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<title><![CDATA[Hays Pharma Pharmaceutical Jobs - Switzerland]]></title>
<link>http://www.hayspharma.com/</link>
<description><![CDATA[Hays Pharma Jobs in Switzerland]]></description>
<lastBuildDate>Tue, 07 Sep 2010 12:37:24 GMT</lastBuildDate>
<language>en-gb</language>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/regulatory-affairs/ra-officer/HQ00015570</guid>
<pubDate>Sun, 05 Sep 2010 23:00:00 GMT</pubDate>
<title><![CDATA[RA Officer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/regulatory-affairs/ra-officer/HQ00015570</link>
<description><![CDATA[My client is looking for a Regulatory Affairs Officer. You will be based in Geneva, Switzerland. You will be responsible for the following assignments under supervision of the Regulatory Affairs Manager

* New product registration and maintenance of product licenses (variations, renewals)
* Communications with National health authorities (Swissmedic)
* Preparation and writting of registration files in liaison with company&#039;s technical departments (QA/QC/Production)
* Development, writting and compliance checking of packaging/labelling materials 
* Providing regulatory direction and support to Sales team


Qualification and experience required
**********************************************

* University degree in Pharmacy (preferred), biomedical or equivalent. 
* Regulatory Affairs certification is a plus.
* Some years experience in Regulatory affairs field. 
* Good written and oral communication skills. 
* Fluency in English and German (French a plus)
* Knowledge of relevant regulations (Swiss and EU),
* Strong attention to details and ability to multitask]]></description>
<category><![CDATA[Regulatory Affairs]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/regulatory-affairs/ra-specialist/HQ00015028</guid>
<pubDate>Sat, 04 Sep 2010 23:00:00 GMT</pubDate>
<title><![CDATA[RA Specialist]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/regulatory-affairs/ra-specialist/HQ00015028</link>
<description><![CDATA[Mein Klient ist weltweit die Nummer eins bei den Medikamenten zur Behandlung von Eisenmangelerscheinungen. Sie sind für die Forschung, Entwicklung, Produktion der international vertriebenen Eisenpräparaten zuständig. 
 
******** REGULATORY AFFAIRS SPECIALIST ***********

AUFGABENGEBIET 
Diese spannende, interdisziplinäre Aufgabe beinhaltet die Betreuung von Registrierungsdossiers weltweit Verfassen, Zusammenstellen und Aufdatieren der Dossiers unter Berücksichtigung der internationalen Vorschriften (EU, FDA, ICH). Des weiteren sind Sie die Schnittstelle zu anderen Abteilungen, Partnern und regulatorischen Behörden auf nationaler und internationaler Ebene. Ein Teilaspekt ist die Erstellung von Dokumenten in Zusammenarbeit mit den Fachabteilungen im Bereich von Pharmakovigilanz/Medizin, z.B. Company Core Data Sheet, PSUR und SmPC/PIL. Ihre ausgezeichneten Sprachkenntnisse in Englisch sind dabei unerlässlich. 
 
IHR PROFIL 
Sie verfügen über ein abgeschlossenes Hochschulstudium in Pharmazie oder naturwissenschaftlicher Bereich und haben ausgewiesene Qualifikationen und Erfahrungen im Bereich internationale Registrierung. Sie freuen sich auf die konstruktive Zusammenarbeit mit einem dynamischen, gut eingespielten Team, um anspruchsvolle Ziele kreativ zu erreichen.]]></description>
<category><![CDATA[Regulatory Affairs]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/medical-information/principal-medical-writer/HQ00015039</guid>
<pubDate>Sat, 04 Sep 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Principal Medical Writer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/medical-information/principal-medical-writer/HQ00015039</link>
<description><![CDATA[Principal Medical Writer - Location Basel - Senior / Principal Medical Writers
Are you an experienced Medical Writer considering your next career move?
 
My client, an international agency with offices around the globe,  is continuing to expand and has exciting opportunities in London, Manchester, Oxford and Basel.
 
Continuing to work at the cutting edge of science with some of the most influential clinicians in the world, My client will provide you with the opportunity to develop and expand your scientific knowledge within specialist disease areas including immunology, oncology, rheumatology, vaccines, hepatitis and haematology.
 
They place the highest value on the scientific knowledge and expertise of their employees in the belief that good science makes good communication.  They have built a formidable reputation as an employee-focussed employer, offering talented and committed individuals a career structure that helps them develop both personally and professionally.
 
Successful candidates will have at least some relevant medical information, communications or marketing writing experience (agency or pharmaceutical) and a strong life sciences background to BSc, MSc or PhD level]]></description>
<category><![CDATA[Medical Information]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/senior-principal-biostatistician/HQ00013781</guid>
<pubDate>Sat, 04 Sep 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior / Principal Biostatistician]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/senior-principal-biostatistician/HQ00013781</link>
<description><![CDATA[A leading international pharmaceutical company has 2 urgent permanent Principal Biostatistician opportunities to be based in there head office in Switzerland.

KEY RESPONSIBILITIES:

- Responsible for all statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence. For example, clinical trial design/planning, regulatory interactions, analysis plan, reporting activities, CTD and summary documents, exploratory analyses, and statistical consultation.
- May be assigned to lead a small project or parts (e.g., indication(s)) of a project, initially under the supervision/guidance of a more experienced statistician but with increasing autonomy and accountability.
- Track clinical trial/allocated project activities and milestones.
- Interact with the Method group as appropriate.
- Ensure timelines and adequate quality of all Biostatistics and Statistical Reporting (B&SR) deliverables for the assigned trials and project tasks.
- Follow processes and adhere to the clients and project specific standards as well as Health Authority requirements (SOPs, Master Analysis Plan, full development project specifications, and regulatory guidelines).
- Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and B&SR team.
- Participate in or lead non-clinical project activities as needed.

Minimum requirements:
- Master Degree in Statistics (or equivalent degree) with at least 5 years of pharmaceutical experience or PhD in Statistics with at least 2-3 years of pharmaceutical experience
- Experience in all tasks of a Trial Statistician
- Experience in Oncology Statistics and/or regulatory activities would be advantageous
- Fluent English (oral and written)
- Proven knowledge and expertise in statistics and its application to clinical trials
- Proven knowledge of drug development and Health Authority guidelines
- Knowledge of statistical software packages (e.g. SAS, S+)
- Good communication and presentation skills
- Good team player]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/statistics-sas/contract-biostatistician/HQ00015294</guid>
<pubDate>Fri, 03 Sep 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Contract Biostatistician]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/statistics-sas/contract-biostatistician/HQ00015294</link>
<description><![CDATA[A leading pharmaceutical company currently has a urgent contract Biostatistician opportunity to join their growing team. You would be based in there head office in Switzerland.

PURPOSE OF ROLE

We are seeking professionals and experienced biostatisticians to support Clinical Development in the main therapeutic areas Neurodegenerative diseases, Oncology, Autoimmune & Inflammatory Diseases, Endocrinology and Fertility.

Responsibilities include designing PoC studies, phases II, III and IV clinical trial clinical trials, accurately interpreting and clearly communicating statistical results and concepts, co-authoring final integrated reports of clinical trial data and interacting with regulatory agencies.

The role will be to provide and validate statistical information development, outcomes reporting and protocol/CRF development and developing general statistical standardisation initiatives. Positions will also serve as biostatistical support for other Departments (i.e., Marketing) for the corresponding therapeutic areas, ensuring the timely and accurate completion of all statistical aspects of assigned clinical trials, including data mining and exploratory works.

In this role, you will serve as the project biostatistician for assigned Phase IIIB and IV studies.

Qualifications

Qualified candidates will have either a PhD in Statistics or Biostatistics and some pharmaceutical/biotechnology experience or a Master&#039;s degree in Statistics or Biostatistics and significant experience. Full knowledge of advanced statistical analytical methods, clinical trial research, regulatory requirements, programming skills, and statistical software is required.

You must have demonstrated competency in SAS, as well as in analyzing clinical trial data. Comprehensive project management, problem solving and prioritization skills are a must. Fluency in English and excellent communications skills are essential. Prior experience in managing CROs and external vendors will be an asset.]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/team-leaders-biostatistics/HQ00015313</guid>
<pubDate>Fri, 03 Sep 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Team Leaders - Biostatistics]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/team-leaders-biostatistics/HQ00015313</link>
<description><![CDATA[A Global pharmaceutical company currently has several new opportunities for Team Leaders within Biostatistics, these are permanent positions. You would be based in there head office in Switzerland. 

KEY RESPONSIBILITIES

- Leader of a global and cross-functional team to deliver at the trial/project level in support of the overall strategy. 
- Responsible for data management, statistics, statistical reporting and coordinating with medical writing and database programming. 
- Project deliverables include statistical input into clinical development plans, protocols, submission, publication and- risk management plans, clean and complete databases, analysis for clinical trials, submissions, RMPs, and HA questions, publications, and, submission documentation for a designated project. 
- Primary point of contact for assigned projects/programs.

Minimum requirements

- Degree in science or relevant discipline or equivalent experience.
- Broad experience in clinical development (e.g. experience as functional team leader). 
- Successful project management experience.
- Regularly demonstrated active contributions to line function as well as ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills.
- Proven track record in successfully leading interdisciplinary teams.
- Excellent communication, collaboration and negotiation skills. 
- High level understanding of clinical development, quality, standards and policies.
- Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems (e.g., MS-project) and associated processes. Degree in science or relevant discipline or equivalent experience.
- Broad experience in clinical development (e.g. experience as functional team leader). 
- Successful project management experience.
- Regularly demonstrated active contributions to line function as well as ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills.
- Proven track record in successfully leading interdisciplinary teams.
- Excellent communication, collaboration and negotiation skills. 
- High level understanding of clinical development, quality, standards and policies.
- Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems (e.g., MS-project) and associated processes.]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/regulatory-affairs/change-manager-packaging/HQ00015563</guid>
<pubDate>Thu, 02 Sep 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Change Manager Packaging]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/regulatory-affairs/change-manager-packaging/HQ00015563</link>
<description><![CDATA[My client, a world-leading pharmaceutical company are currently looking for a 

Change Manager Packaging (Technical Registration)

to join them on a contract basis (15 months) in their HQ in Basel

Tasks
Change assessment and planning

* evaluate regulatory impact @ local level and fill in change form
* evaluate regulatory impact @ global level and fill in change form
* attend planning meetings and give advice
* plan dispatch timeline
* evaluate bundling possibility with other regulatory departments

Change package preparation and dispatch
* allocate Change Number in Database
* establish country list
* finalize country list in agreement and timeline with regulatory departments, product managers, logistics and enter list into database
* write technical registration documents and/or organize documents (cmc, certificates, declarations, pictures etc.)
* compile the technical regulatory change package (Cover letter, To whom it may concern letter, Questionnaire) 
* make dossier ready to dispatch
a) non-eCTD-electronic Submission sharedrive for b-/I countries
b) eCTD  tracking sheets for EU submission order Dispatch at Dispatch Center

Dispatch follow- up.
* tracking of country feedback in database
* provide adequate feedback and/or required additional documents if requested to the countries (if necessary in collaboration with Center of Excellence )
* send reminders if necessary
* write completion letter if necessary in collaboration with regulatory departments and logistics
* keep logistics informed regarding implementation timeline delays and shifts
* follow - up on tracking in database until change is finalized in all countries

General activities
* store case specific electronic and hardcopy documents/information acc. to departmental rules
* maintain technical regulatory packaging change list
* fill in forthcoming change dispatch list for other regulatory department
* work on renewals requests and provide packaging material specifications

The ideal candidate has gained experience in change management for packaging systems and devices within technical registration combined with solid PC knowledge, ideally fluent German and English and a profound knowledge of regulations regarding changes (especially packaging)]]></description>
<category><![CDATA[Regulatory Affairs]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/clinical-trial-head/HQ00014994</guid>
<pubDate>Thu, 02 Sep 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Clinical Trial Head]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/clinical-trial-head/HQ00014994</link>
<description><![CDATA[Clinical Trial Head - My client, a leading pharmaceutical company is currently looking to employ a Clinical Trial Head based in Basel.  

In this role you will be accountable for the:
- writing of clinical protocols and related documents in collaboration with the GPMD/PSL/MSE** 
- lead the clinical trial protocol development process; 
- contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in - - other line functions; 
- obtain approval from internal review boards. 
- Collaborate with the Medical Advisors of the major local medical organizations to ensure country feedback is adequately integrated into protocol. 
- Participate in development of effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. 
- Contribute to trial-related advisory boards. Lead investigators meetings. 
- Lead protocol training meetings to support my client&#039;s local medical organizations in the conduct of regional meetings
- Accountable for all internal meetings related to the clinical trial. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures chair CTT meetings, report study progress and issues with their resolution plan to International Clinical Teams; lead trial level interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and the client&#039;s local medical organizations. In collaboration with the GPMD/PSL/BSL and/or MSE, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations. Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Business Relationship Manager in the Contract Management Department. Forecast trial resources needs (headcount and external costs) accountable for the development, management and tracking of trial budget working closely with the TA program operations group. Accountable for accuracy of trial information in all trial databases and tracking systems. Assess resource needs with program and TA management to ensure appropriate line function allocation. Assign short to mid-term responsibilities to CM who assist in the planning, conduct and reporting of clinical trials; independently manage the day-to-day interactions with the CMs; contribute to talent and career development of TA staff; provide input to performance evaluations and promotion recommendations of the CMs. Contribute to the development of clinical sections of regulatory documents like Investigators&#039; Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions. Accountable that program specific standards (e.g., CRFs, outsourcing specifications, data monitoring and validation plans) are developed and applied across all trials to ensure consistency of clinical dossier. Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned. Participate in the on-boarding, and training of new staff. Mentor TA staff. May serve as faculty member for training programs.  We offer relocation service.  * The therapy areas in my client&#039;s are 1. CVM (Cardiovascular & Metabolism) 2. IID (Immunology & Infectious Diseases) 3. EM (Established Medicines) 4. NSO (Neuroscience & Ophthalmics) 5. Resp (Respiratory)  **IID Development Business Franchise Immunology and Infectious Diseases  GPMD Global Program Medical Director PSL Program Section Leader MSE Medical Scientific Expert CTT Clinical Trial Team BSL Brand Safety Leader TA Therapy Area (Immunology and Infectious Diseases) CM Clinical Manager
	
Minimum requirements:	
- Advanced degree or equivalent education/degree in life science/healthcare is required. MD, PhD preferred.  
- Languages Fluent English (oral and written)  
- Experience at least some technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation. 
- Specific experience in the development of clinical trial protocols and trial start-up. 
- Proven ability to work independently, proven leadership experience to lead a multidisciplinary trial team in a complex matrix environment. 
- Results oriented work style, high commitment, strong skills in team work and communication.  
- Experience in developing effective relationships with key investigators. 
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process. 
- Knowledge assigned to a therapy area is an advantage.]]></description>
<category><![CDATA[Clinical Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/clinical-data-management/senior-clinical-data-manager/HQ00015567</guid>
<pubDate>Thu, 02 Sep 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior Clinical Data Manager]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/clinical-data-management/senior-clinical-data-manager/HQ00015567</link>
<description><![CDATA[My client a leading pharmaceutical company currently has a Senior Clinical Data Manager opportunity to join their growing team. You would be based in there head office in Switzerland. 

PURPOSE OF ROLE

To perform project management tasks within DM for trials and projects. To represent DM on the Trial Team. To be responsible for the creation of the CRF and key documents like the Data Management Plans, Reports and other documents, to perform data cleaning activities of in-house trials. To provide training. To supervise CRO activities regarding details of data collection, handling and transfer. Ensure database is ready for lock. Assure quality of data by establishing and administering of guidelines and standards for data management. To lead process and technology improvement and re-engineering initiatives.
 
Qualifications

* Master or Diploma of Science preferred
* Excellent knowledge of English
* Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to 4 years
* Successful completion of multiple studies from beginning to end providing a full scope of DM experience
* Proven experience with the use of CDISC and related standards (e.g. SDTM)
* Proficiency with data management systems such as ClinTrial™, InForm™
* Basis knowledge of SQL is a plus
* Good knowledge of SAS
* Understanding of relational database design
* Proficient Computer Skills e.g. word processing, spreadsheets
* Knowledge of medical terminology required
* Excellent knowledge of regulations and guidances with regard to clinical development and the systems used in this context]]></description>
<category><![CDATA[Clinical Data Management]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/scientific-engineering/ingenieur-device-developemnt/HQ00015566</guid>
<pubDate>Thu, 02 Sep 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Ingenieur Device Developemnt]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/scientific-engineering/ingenieur-device-developemnt/HQ00015566</link>
<description><![CDATA[Mein Klient, ein führendes Baseler Pharmaunternehmen sucht momentan für den Zeitraum von bis zu 15 Monaten eine/n
Ingenieur Device Development (m/w)
Standort Basel
Dauer 15 Monate (Dez. 2011)
Excellenter Stundensatz

Aufgaben und Verantwortung
Mitarbeit bei der Entwicklung von Devices / Primärbehälter / Combination Products für parenterale Darreichungsformen
Enge technische Koordination und Abstimmung mit abteilungsinternen und -externen Stellen
Eigenständige Kontaktaufnahme zu und das Management von externen Anbietern von Primärverpackungen, Devices, Fertigungstechnologien, Laborserviceleistungen etc.
Technische Prüfung, Analyse und Bewertung der Devices / Primärbehälter / Combination Products im Rahmen der Entwicklungsaktivitäten
Mitarbeit in technischen und interdisziplinären  Teams Experteninput, Übernahme von Verantwortung im Hinblick auf technische Meilensteine und Entwicklung
Interaktion und Kooperation mit Kollegen in TR&D (u.a. Clinical Supply, QVS, Formulation Development, Analytik, Bioprocess, QA, technische Registrierung, Produktion)
Mündliche und schriftliche Berichterstattung über Stand der Arbeit und Ergebnisse von Projekten an Gruppenleiter bzw. Abteilungsleiter
Dokumentation der Entwicklungsarbeiten gemäss den zum jeweiligen Zeitpunkt geltenden Regeln (z.B. Laborberichte, Development Reports, Support für die Erstellung von CTDs)
Übernahme von weiteren Aufgaben und Pflichten nach Zuteilung durch den Vorgesetzten

Erwünschte Qualifikationen

Ausbildung als Ingenieur (m/w) 
Erfahrung mit Entwicklung  von Devices / Primärbehälter / Combination Products
Gute Kenntnisse über Fertigungsprozesse für Devices / Primärbehälter / Combination Products sowie Materialtechnologie (Kunststoffe, Metalle, Glas etc.) 
Erfolgreiche Arbeitserfahrung in komplexen Projekten
Gute PC-Kenntnisse
Deutsch und Englisch in Wort und Schrift
Kenntnisse der Regelwerke im pharmazeutischen GMP-Umfeld und im Device-Umfeld


Interessiert? Bitte senden Sie mir Ihren aktuellen Lebenslauf mit Honorarvorstellung.

HAYS Pharma is acting as a recruitment/employment company on behalf of our client.]]></description>
<category><![CDATA[Scientific & Engineering]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/expert-clinical-manager-cardio/HQ00015527</guid>
<pubDate>Tue, 31 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Expert Clinical Manager - Cardio]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/expert-clinical-manager-cardio/HQ00015527</link>
<description><![CDATA[My client, a leading Pharmaceutical company based in Basel, Switzerland are looking for 3 Expert Clinical Managers to work in the Cardio team to start ASAP on 12 month contracts.

Job Purpose

Responsible for supporting, under the leadership of the Clinical Trial Head (CTH), all aspects of clinical trial(s) (Phase II through lifecycle management) and program level activities as assigned. 

Major Accountabilities 	

1. Support CTH in ensuring all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of protocol and related documents; development of study tools, guidelines and training materials; management of clinical study material; implementation of issue resolution plan; preparation of clinical outsourcing specifications. 
2. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget. 
3. Support the development, management and tracking of trial budget working closely with the TA program operations group. 
4. Support CTH in managing interactions with Global Clinical Development Operations and other relevant functions including Drug Supply Management and company&#039;s local medical organizations. 
5. Accountable for accuracy of trial information in all trial databases and tracking systems. 
6. Contribute to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing. 
7. May participate in the organization and logistics of various oversight or Advisory Boards. 
8. Point of contact for managing/answering questions related to trial procedures and patients&#039; eligibility. 
9. Draft CTT meeting minutes. Participate in International Clinical Team meetings. 
10. May organize and chair trial sub-teams within the scope of his/her delegated responsibilities. 
11. Assist with program level activities (e.g., tracking of CD&MA brand-related publications, development of clinical sections of regulatory documents like Investigators&#039; Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions). 
12. Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned. 

Key Performance Indicators 	

Job Dimensions 

Number of Associates: Direct None, Indirect None 	
Financial responsibility: None 	
Impact on the organisation: Successful completion of trial operational activities which enable CTT to fulfil deliverables according to agreed timelines and budget. 	

Ideal Background 	

Education 	 
Advanced degree or equivalent education/degree in life science/healthcare required if no previous experience in clinical research. or Bachelor degree or equivalent education/degree in life  	

Sr CM Sr CM 2 
science/healthcare required if accompanied with previous experience in clinical research.  	
Languages: Fluent English (oral and written) 
	
Experience 	
Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in supporting trial planning, executing, reporting and publishing activities.  
Good communication, organization and tracking skills.  
Proven networking skills and ability to share knowledge and experience amongst colleagues.  
Proven ability to work both independently or in a team setting, and to meet set goals by managing own timelines.  
Knowledge of Good Clinical Practice; basic knowledge of clinical trial design; understanding of the overall drug development process.  
Basic knowledge of principles for trial budgeting is preferable.  
Basic knowledge of Therapy Area preferable.]]></description>
<category><![CDATA[Clinical Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/clinical-operations-manager/HQ00015528</guid>
<pubDate>Tue, 31 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Clinical Operations Manager]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/clinical-operations-manager/HQ00015528</link>
<description><![CDATA[My client is a leading Pharmaceutical company in Basel.  They are looking for a contract Operations Manager in Clinical Medical Services /  ICRO to work on a 12 month contract, starting ASAP.

Reports to (Job Title): Head of Operations and Business Development    		
	
Job Purpose	
Manage all operational aspects of clinical trials / projects accountably including trial allocation according to patient accessibility. Perform trial feasibility assessment together with the ICRO organization and ensure optimum utilization of resources in cooperation with the Regional Heads ICRO and setting of realistic timelines together with the Clinical Team and organize input to the protocol design. Track performance and quality aspect.

Responsible for supporting the Clinical Project Manager (CPM) in the conduct of clinical trial(s) activities as assigned. Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards.
Deputize for CPM in interaction with Sponsor(s as needed).

Major Activities		
Work closely with the Regional Heads ICRO and local ICRO Managers on trial feasibility and local resource utilization
Participate in  CT meeting and give input on trial protocol feasibility based on CPO / Region assessment
Agree with Sponsor(s) on realistic project and trial timelines. Escalate to higher level in the organization if no agreement can be achieved
Provide common understanding to Clinical trial teams (CTTs) of the competitive environment in clinical trial conduct while leading the development and implementation of contingency plans
Accountable for project / trial allocation plans and implementation following the global allocation strategy to ensure optimum patient accessibility, resource utilization / allocation and country development, agree with the Global Trial Allocation Board.
Determine external clinical trial costs and internal ICRO monitoring resources for assigned projects. Negotiate trial costs with the CPOs. Monitor ICRO resource requirements.
Responsible for the delivery of individual trial data on agreed time and in acceptable quality together with the Regional Heads ICRO and the CPOs
Work with CTH / DM / ICRO Managers to identify potential quality issues and implement actions to resolve them
Work with EDM to ensure timely availability of reports / activities needed to track trial performance. Escalate issues endangering data quality to the next level if no solution can be achieved
Provide liaison interface with other line functions  EDM, IVRS, CRO Management,  Logistics, etc.
Support CPM in the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis and reporting.
Support CPM in preparing training materials and presentations related to the planning and conduct of the trial.
Support CPM in interactions with Global Line Functions.
Accountable for accuracy of trial information in all trial databases and tracking systems.
Participate in the organization and logistics of various oversight and Advisory boards.
Support CPM in clinical trial and project team meetings. Organization, minutes preparation. Budget management.
Support CPM in regular updates of trial databases and tracking systems.


Key Performance Indicators  
Key trial deliverables and milestones achieved
External & internal customer satisfaction survey

Job Dimensions  	
Number of associates: None.		
Financial responsibility: (Budget, Cost, Sales, etc.)    	
Indirect responsibility: responsible for the forecast and actual cost of individual clinical trials(investigator fees/TCF related) within a development program. Ensuring that the regular alignment of forecasting vs actuals to ensure tracking and control is performed.
Impact on the organization: ptimal allocation of studies balancing the need for high quality, cost effective trials and best use of resources and expertise available in the CPOs. This process  will support the strategic resourcing model that will increase the productivity of the ICRO organization with year on year gains.
Together with CPM, participate in the timely delivery of high quality analysis of clinical trial data to sponsor. Company to be seen as a credible, ethical and preferred partner by Sponsors.		

Ideal Background 	
Education (minimum/desirable): Life Science/Nursing degree  or equivalent.		
Languages: Fluent English (oral and written). 		
Experience/Professional requirement	
Experience in clinical development/project management, including involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and budgetting activities.
Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
Proven ability to work both independently or in a team setting, including a matrix environment
Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process.
Good leadership, negotiation and project management skills
Robust knowledge of the regulatory and local requirements within regions and countries 
Demonstrated ability of establish effective working partnerships with RICRO Heads, CPO associates, and TA associates
Medical / Scientific knowledge of the assigned  therapy area and associated trial designs 
Demonstrated presentation and diplomacy skills
Willingness to act accountably in project / trial management]]></description>
<category><![CDATA[Clinical Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/biostatistician-sas-programmer/HQ00015095</guid>
<pubDate>Tue, 31 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Biostatistician & SAS Programmer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/biostatistician-sas-programmer/HQ00015095</link>
<description><![CDATA[My client a leading biopharmaceutical company is looking for a contract Statistician and contract SAS Programmer. These are 1 year contracts ideally to start September / October 2010. Excellent rates of pay.

Biostatistician - Key Responsibilities
- Informs and suggests solutions to the project statistician on critical issues within trial. 
- Makes sure that the statistical part of the protocol, the statistical analysis plan and the study reports are reviewed and approved by the project statistician 
- Discusses protocol and CRF and data transfer specifications with the authors. 
- Writes the statistical section of the protocol stating the hypothesis, defining the planned analysis, primary and secondary variables, time periods, interim analysis specifications, intent-to-treat population and explaining the statistical basis for the choice of sample size.
- Plans details of the randomization schedule with the appropriate members of the clinical trial team. 
- Approves the randomization list. 
- Verifies the consistency of the protocol with the CRF/data transfer specifications. 
- Ensures that the trial design is compatible with the trial objectives.
- Reviews and approves protocol and CRF/data transfer specifications prior to their use or submission to approval committees.
- Discusses, reviews and approves protocol amendments 
- Verifies the appropriateness of the planned analysis and writes the statistical analysis plan. Authorizes the closure/freezing of the databases and release of the randomization list. 
- Asesses the impact of subjects withdrawn/lost to follow-up and of the deviations from planned trial design. 
- Assesses the impact of deviations from distribution assumptions, lack of homogeneity of treatment arms, possible outliers etc. 
- Documents methods and procedures used in the analysis. 
- Plans and directs or performs the programming for the protocol specific data reports and statistical evaluations. Assists in programming and/or validation where appropriate. 
- Discusses and plans model reports, data presentation/statistical evaluation methods and writing responsibilities with the appropriate members of the clinical study team. 
- Writes the statistical section of reports (CSR, integrated safety/efficacy reports and publications). Reviews and approves the reports. 
- Verifies adherence to statistical standards and SOPs/PSPs within the  study. 


SAS Programmer - Responsibilities

- Informs and suggests solutions to the statistician on critical issues within the project. 
- Performs the programming for trial or project specific data reports and statistical evaluations in agreement with the guidelines of the statistician, according to the project quality requirements.
- Discusses data presentation methods with the appropriate members of the project team
- Performs the programming for standard and special analyses and provides the appropriate members of the project team with trial or project specific listings, summary tabulations and graphics
- Maintains up-to-date documentation for the reporting, analysis and graphics software that is under his responsibility
- Provides technical advice and support to other project team members
- Assesses, recommends and develops new standards, policies and procedures
- Supports computerized systems/subsystems implementation that facilitate the handling and the documentation of trial specific or project specific CRF or non-CRF data, including data flow monitoring and reporting tools, according to the project quality requirements
- In agreement with the statistician, designs and implements trial and project analysis database structures and programs the algorithms that are to be applied to the data for the conversion between different database structures]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/regulatory-affairs/ra-manager-human-nutrition-health/HQ00014978</guid>
<pubDate>Sun, 29 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[RA Manager Human Nutrition & Health]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/regulatory-affairs/ra-manager-human-nutrition-health/HQ00014978</link>
<description><![CDATA[My client is looking for a Global Regulatory Affairs Manager Human Nutrition and Health. It is a permanent position based near Basel, Switzerland. My client needs someone with experience in CTD and API submission dossiers. 

Main responsibilities:
*************************
- Manage an international portfolio of pharmaceutical approval dossiers.
- Assist in development and review of RA work processes
- Assist in the development of regulatory strategy and update strategy based upon regulatory changes
- Maintain annual licenses, registrations and listings Information for a product portfolio.
- Secure regulatory compliance including coverage of product safety
- Participate in professional associations, international industry/trade groups and relevant standards organizations

Ideal profile:
**************
- University degree in natural sciences and/or pharmaceutical sciences
- A solid work experience in Regulatory Affairs in pharmaceutical field is required; direct experience about maintenance of certificate of suitability (CEPs) would be welcomed.
- Project management skills 
- Very good command of English language 
- Strategic thinking and sense for practical solutions 
- Precise working style, persistence in pursuing objectives 
- Strong sense of communication and good team working skills]]></description>
<category><![CDATA[Regulatory Affairs]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/health-economics-and-outcomes-research/director-global-health-economics-and-outcomes-research/HQ00014734</guid>
<pubDate>Sun, 29 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Director Global Health Economics and Outcomes Research]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/health-economics-and-outcomes-research/director-global-health-economics-and-outcomes-research/HQ00014734</link>
<description><![CDATA[My client is a rapidly growing Global Pharmaceutical company who is looking to expand is HE&OR function due to pipeline.  

Key Tasks:
Identify, evaluate, retain and oversee aglobal network consultants and contract organizations to execute the health outcomes work. In particular, representing the HE&OR function at team meetings, BU meetings, and meetings with senior management to ensuring provision of HE&OR outputs to support internal decision making during product development and commercialization to 
Produce high-quality project deliverables to agreed timelines and budgets 
Develop and maintain a strong network of professional contacts 
Produce cost effectiveness model-based economic evaluations, budget impact analyses and burden of illness studies 
Support adaptation of economic models in accordance with local requirements/guidelines 
Prepare economic and product value strategy dossiers 
Contribute to reimbursement and HTA submission documentation 
Perform prosepective or retrospective database analyses 
Provision of prompt health economic assessments to support decisions on possible in-licensing of products made jointly with Commercial, BU, and R&D colleagues 
To ensure development of programs to support value proposition(s) for product pipeline globally, including 
Contribute to the design, HE&OR endpoint selection, reporting and analysis of clinical studies 
Support scientific content output based on clinical studies ensuring publications support for HE&OR analyses for products where available 
Maintain awareness of global HEOR requirements, regulatory legislation, payor trends & requirements 
Research and perform critical analysis of medical and scientific evidence as the basis for disease management guidelines, P&T Committee actions, and pharmacoeconomic comparisons of therapies. 

Education and Experience Requirements 

Masters degree in Health Economics, Pharmacoeconomics, decision sciences (or similar) with significant experience in global pharmaceutical or medical device industry or PhD in Health Economics, Pharmacoeconomics, decision sciences (or similar) with significant experience. Alternatively, significant experience interacting with Health Technology Assessment Agencies. Experience in interfacing with external scientific bodies & preference for experience with interactions with reimbursement agencies in US and/or Europe.]]></description>
<category><![CDATA[Health Economics and Outcomes Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/statistics-sas/principal-biostatistician/HQ00014741</guid>
<pubDate>Sun, 29 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Principal Biostatistician]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/statistics-sas/principal-biostatistician/HQ00014741</link>
<description><![CDATA[My client a leading pharmaceutical company currently has a Principal Biostatistician opportunity to join their growing team. You would be based in there head office in Geneva, Switzerland.

PURPOSE OF ROLE

We are seeking professionals and experienced biostatisticians to support Clinical Development in the main therapeutic areas Neurodegenerative diseases, Oncology, Autoimmune & Inflammatory Diseases, Endocrinology and Fertility. 

Responsibilities include designing PoC studies, phases II, III and IV clinical trial clinical trials, accurately interpreting and clearly communicating statistical results and concepts, co-authoring final integrated reports of clinical trial data and interacting with regulatory agencies. 

The role will be to provide and validate statistical information development, outcomes reporting and protocol/CRF development and developing general statistical standardisation initiatives. Positions will also serve as biostatistical support for other Departments (i.e., Marketing) for the corresponding therapeutic areas, ensuring the timely and accurate completion of all statistical aspects of assigned clinical trials, including data mining and exploratory works.

In this role, you will serve as the project biostatistician for assigned Phase IIIB and IV studies.

Qualifications

Qualified candidates will have either a PhD in Statistics or Biostatistics and some pharmaceutical/biotechnology experience or a Master&#039;s degree in Statistics or Biostatistics and solid experience. Full knowledge of advanced statistical analytical methods, clinical trial research, regulatory requirements, programming skills, and statistical software is required. 

You must have demonstrated competency in SAS, as well as in analyzing clinical trial data. Comprehensive project management, problem solving and prioritization skills are a must. Fluency in English and excellent communications skills are essential. Prior experience in managing CROs and external vendors will be an asset.]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/project-statistician/HQ00013996</guid>
<pubDate>Sat, 28 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Project Statistician]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/project-statistician/HQ00013996</link>
<description><![CDATA[Expert Statistician - The Expert Statistician is fully responsible for scientific input into projects and studies in both early and late phases of development (Profiling and PK studies). The expert statistician is fully responsible for the operational aspects of the project, and for effective interactions with the project teams.

Main Activities

-  Provide operational oversight for all CIS deliverables for assigned projects and studies, including full responsibility for timelines and quality standards. Scope of projects may include those in very early phases of development leading up to a proof of concept (PoC), but also the ED aspects of late phase projects and submissions. 

-  Provide scientific input and advise to project and study teams, and provide guidance and leadership with respect to innovative approaches to study design and decision making; ensure appropriate involvements of M&S, Statistical Methodology and other internal or external statistical consultants in all assigned projects.

-  Contribute to Clinical Development Plans for assigned projects.

-  Partner with the project and study teams, and represent Biostatistics in review and decision boards such as protocol review committee and PoC peer review.  

-  Be accountable to the TA lead statistician in the Respiratory TA and to the global head of ED Biostatistics for timeliness and high quality of all CIS deliverables in assigned projects.

-  Interact with Health Authorities and external consultants and experts as appropriate.

-  Support evaluation of in-licensing opportunities as appropriate.

-  Provide technical statistical leadership within the ED Biostatistics group, and may serve as mentor to more junior members of staff.

-  May contribute to major potentially cross-functional initiatives to improve infrastructure and efficiency, or may lead a small initiative herself/himself.


Measurable  Responsibilities

-  Quality and timeliness of statistical deliverables in assigned projects
-  Adequate representation of ED Biostatistics on the project-level -  Visible contributions of ED Biostatistics to the clinical development strategies and plans in assigned projects, including PoC summits, dose finding strategies, and clinical development plans.
-  Appropriate use of innovative designs and methods in assigned projects and trials.


Preferred Skills/Experience

-  Preferred PhD in Statistics (or equivalent degree/knowledge/expertise).
-  Experience gained in all main tasks of a Senior Statistician, and experience as project statistician for international clinical teams or comparable experience in similar ED role.  
-  Good leadership skills. 
-  Very good project management skills. 
-  Very good communication and presentation skills
-  Good knowledge of the drug development process and relevant HA guidelines.  
-  Basic coaching and mentoring skills. 
-  Good team player. 
-  Strong knowledge and expertise in statistics and its applications in clinical trials.
-  Experience with implementation of novel methods and/or innovative strategies]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/regulatory-affairs/director-regulatory-affairs/HQ00015245</guid>
<pubDate>Fri, 27 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Director Regulatory Affairs]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/regulatory-affairs/director-regulatory-affairs/HQ00015245</link>
<description><![CDATA[My client is looking for 2 Director Regulatory Affairs. Under the direction of the Vice President of International Regulatory Affairs, the Director of Regulatory Affairs is responsible for developing and directing objectives, policies and programs pertaining to development, marketing, and life cycle of the drug in WW markets as directed by the business objectives.  This role includes the lead regulatory responsibility for global registration and life cycle support for the Angioedema franchise.  	

You will report into the VP of International Regulatory Affairs 	
Department Global Regulatory Affairs	
Location French part of Switzerland	
  	
	
Responsibilities	
******************
	
* Designs and implements regulatory strategies to obtain, maintain and extend the product registrations globally.
* Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. 
* Key member of the franchise and brand teams, and liaison with the Program Executive. 
* Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., CTAs, MAAs, Variations, and other relevant regulatory filings.  
* Actively works with Project Management and Operations to ensure alignment of regulatory implementation associated with submissions. 
* Serves as corporate liaison as necessary with WW regulatory agencies to develop effective professional relationships as well as our positive company image. 
* Provides guidance to all appropriate departments to assure compliance with applicable regulations.   
* Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel. 
* Attends key meetings with Health Authorities to ensure full discussion of issues and opportunities. 
* Provides broader guidance on regulatory interpretation to the staff. 
* Makes recommendations for regulatory department operating procedures.
* May be responsible for creating and reviewing SOPs as needed. 	

Education & Experience Requirements	
*********************************************	
* Higher degree in a scientific field is strongly preferred.
* Extensive pharmaceutical experience including some with applicable EU or International-focused Regulatory Affairs experience
* Management experience; or an equivalent combination of education and experience.  
	
Key Skills and Competencies	
**********************************	
* Demonstrated ability to routinely accept empowerment from senior leadership to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation. 
* Strong competency in understanding regulatory requirements and emerging regulatory landscape  
* Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents. 
* Experienced in responding to inquiries or complaints from regulatory agencies. 
* Ability to present complex issues highly effectively in oral and written form. 
* Proven ability to work successfully with cross-functional teams and influence appropriate plans and actions. 
* Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines. 
* Must be able to work highly effectively in a global, fast paced environment with demonstrated ability to handle multiple competing tasks and demands. 
* Excellent interpersonal, communication, analytical, managerial, and organizational skills. 
* Ability to effectively present information to senior management, public groups, and other departments. 
* Consistently demonstrates and models core values. 
* Up to 25% international travel could be expected]]></description>
<category><![CDATA[Regulatory Affairs]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/regulatory-affairs/senior-director-ra/HQ00015246</guid>
<pubDate>Fri, 27 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior Director RA]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/regulatory-affairs/senior-director-ra/HQ00015246</link>
<description><![CDATA[My client is looking for a Senior Director, Regulatory Affairs EU. Under the direction of the Vice President, International Regulatory Affairs, the Senior Director Regulatory Affairs, EU is responsible for leading the EMA region regulatory function, based in Switzerland. The individual will serve as the liaison between the company and EMA, Swissmedic and regulatory agencies in the EU member states and ensure timely approvals for the products in these markets. Will coordinate all aspects of EU regional regulatory strategy within Global RA. In addition, this individual will be responsible for a specific lysosomal disease franchise strategy. 	

Essential Functions	
************************
* Oversees and directs the European regulatory team to advance the development, commercialization and life cycle of the products  
* Provide European regulatory expertise and perspective for the clinical development and manufacturing of company&#039;s product pipeline leading to rapid approvals.   
* Serves as corporate liaison with relevant global regulatory agencies, as well as European Medicines Agency, SwissMedic and regulatory agencies in the EU member states to develop effective professional relationships as well as a positive company image. 
* Develops and implements EU regulatory strategy for integration in the product development plans and strategic product lifecycle activities. 
* Works with global regulatory Franchise strategists to direct key strategic decisions on commercial programs Designs and implements regulatory strategies to obtain, maintain and extend product registrations globally. 
* Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. 
* Key member of one franchise and brand teams, and liaison with the specific Program Executive. 
* Provides guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. 
* Actively trains/mentors staff. 	
* 25% travel anticipated 

Education & Experience Requirements	
*********************************************
	
* M.D., Ph.D, or Pharm.D. preferred 
* Extensive experience in drug/biologics development the EU pharmaceutical and biotechnology industry or Government Health Agency, with some years in a regulatory leadership role.  Experience in biologics, drug safety, pharmacovigilance and/or risk management preferred.  
	
Key Skills and Competencies	
***********************************
	
* Experience leading the development of regulatory strategy globally and interacting to influence regulators.  Previous biologics experience strongly preferred.   
* Knowledge of the drug development process and laws and regulations affecting pharmaceutical development in EU region.  Prior experience and a track record of success in working with EMA required. 
* Demonstrated ability to motivate, mentor and manage a team. 
* Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.  - Excellent interpersonal, communication, analytical, managerial, and organizational skills. 	

Internal and External Contacts	
************************************
	
Key contacts include regulatory affairs, strategic marketing, franchise leads, clinical and medical affairs, strategic planning and program management.  Externally, interactions with EMA region regulatory agencies.]]></description>
<category><![CDATA[Regulatory Affairs]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/manager-qa-compliance/HQ00014473</guid>
<pubDate>Thu, 26 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Manager, QA Compliance]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/manager-qa-compliance/HQ00014473</link>
<description><![CDATA[My client is looking for a Manager, QA Compliance	for its manufactuing site based in Switzerland (French part), to ensure cGMP compliant processes on the Manufacturing site. 3 direct reports.
	
1.	Competences

This position is responsible for quality assurance (QA) involved primarily with supplier qualification, oversight and update of critical vendor contracts, annual quality reporting, ownership of the deviation handling, investigation and CAPA system. Furthermore the position holder is responsible for the internal audit system as well as the follow up of internal audit CAPAs. 
The position holder assists the Director QA in maintaining and improving the Quality Management System (QMS). As a key member of the Quality Operations team, this position will be working with the QA Compliance Specialists, the Batch Release Office and the qualification/validation engineers to identify and handle process quality, QC laboratory quality and cGMP compliance related issues. The position will be expected to be a reliable source of information and interpretation of quality and cGMP-compliance requirements.

2.	Skills/Knowledge Required

- Extensive experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.
- MSc or equivalent in Science, or related field.
- Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
- Solid understanding of solid oral dosage form manufacturing processes and QC testing methods.
- Proven experience in people management and excellent interpersonal, collaborative and organizational skills.
- Works independently, yet effectively in a team environment.
- Ability to focus attention to details.
- Excellent written & oral communication skills.
- Excellent investigational and QA problem solving skills.
- Knowledge of most common office software (Microsoft Office).

3.	Duties and Responsibilities

* Handles in cooperation with Corporate Quality & Compliance, CQM, the approval and qualification of suppliers of API, bulk drug products, quality control laboratories, packaging services and packaging materials including auditing and establishing Technical/Quality Agreements (QM-POL-006).
* Handles in collaboration with Corporate Quality & Compliance, CQM, the approval of GMP Material suppliers for the production site (QM-POL-006).
* Is responsible for the compilation of the Annual Quality Review Report and the Product Quality Review according the Swiss-, EMEA- and FDA-requirements for the products as assigned.
* Has the overall ownership of the deviation handling, the investigation and the CAPA system including the electronic systems in place. Performs/reviews QA investigations of manufacturing, packaging and laboratory issues (including OOS reports) in support of the Batch Release Office and in collaboration with the QA compliance specialists.
* Is responsible for the internal GMP-audits process (AI-SOP-076) including the yearly internal audit plans necessary, the writing of audit reports (paper or electronically) and is responsible for the follow up and the implementation of the internal audit CAPAs. * Ensures establishment of a liaison for the internal audits performed by the Quality Management (CQM) and ensures follow up of CQM internal audit CAPAs.
* Is responsible for the successful preparation of site authorities&#039; inspections (QM-SOP-017) in collaboration with the QA compliance specialists. 
* Acts as QA representative during authorities inspections as Subject Matter Expert.
* Assist in the improvement of existing processes and the development of new processes or sub-processes related to the QMS.
* Support QC/QA transfers of new products 
* Prepares a monthly trending of Deviations, CAPAs, internal audits and external audits, either as part of shared KPIs or separately, for the Head of International Quality Operations.
* Assigns tasks to direct reports in accordance with their responsibilities and capabilities. Provides continuous support and adequate coaching to ensure direct reports fulfil their duties and objectives. Assures continuous professional development and guidance to direct reports.]]></description>
<category><![CDATA[QA, QC & Validation]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/health-economics-and-outcomes-research/global-director-market-access-and-public-policy/HQ00015234</guid>
<pubDate>Thu, 26 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Global Director Market Access and Public Policy]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/health-economics-and-outcomes-research/global-director-market-access-and-public-policy/HQ00015234</link>
<description><![CDATA[My client is a rapidly growing and exciting Bio Pharma which has created a number of position in their Market Access department.  The Director Market Access & Public Affairs is created to develop international external communications strategies to support market access.  These strategies will be developed in partnership with Global Business Units to aligned functional capabilities including colleagues within Pricing and Reimbursement

Responsibilities include
To develop sustainable external communication strategies to support and accelerate market access for my clients portfolio.  
To form a KOL network and accentuate key market access messages.
To work alongside other departments such as Government Relations, Public Policy or Communications to ensure alignment and consistent messages.

Key Skills
* Strategic level thinking
* Clinical experience/expertise
* Extensive expertise in public policy and external communication 
* Strong negotiating skills
* Networking skills
* Ability to serve complex network of internal customers
* Ability to manage/balance differing functional demands
* Strong business acumen
* Judgment and decision making
* Courage to challenge accepted trends

This is a global position and the role requires extensive travel in Europe & North America.]]></description>
<category><![CDATA[Health Economics and Outcomes Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/specialiste-assurance-qualit/HQ00015218</guid>
<pubDate>Wed, 25 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Specialiste Assurance Qualité]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/specialiste-assurance-qualit/HQ00015218</link>
<description><![CDATA[Mon client est une entreprise pharmaceutique internationale, basée à Geneve,en Suisse, renommée dans le domaine de l&#039;immunologie. Il recherche un SPECIALISTE ASSURANCE QUALITE PHARMACEUTIQUE pour rejoindre le departement Qualité, Environnement et Sécurité.

Département Qualité, Environnement, Sécurité  7 personnes dont le responsable 
Vous reporterez au Responsable Qualité.
CDI

VOS RESPONSABILITÉS
*********************************

* Maintenir et promouvoir l&#039;amélioration de la qualité en relation avec les Bonnes Pratiques de Fabrication (BPF/cGMP)
* Rédiger ou réviser les procédures opératoires
* Réaliser des audits BPF internes et externes (fournisseurs et sous-traitants)
* Participer à la gestion des non-conformités, des réclamations et des changements
* Réaliser les Revues Qualité sur les produits intermédiaires et produits finis
* Participer à la formation GMP des collaborateurs
* Participer à la gestion du risque qualité
* Participer à la libération des produits (vérifications des dossiers de lot), 
* Garantir la conformité réglementaire du site 
* Participer aux divers projets en assurant le support qualité / conformité GMP. 
* Réviser et approuver les protocoles et rapports de qualification / validation

VOTRE PROFIL
*********************

* Pharmacien(ne) ou titre universitaire jugé équivalent (maîtrise ou master)
* Expérience dans l&#039;industrie pharmaceutique, de préférence sur les produits biologiques
* Connaissances des exigences réglementaires (conformité des installations, GMP)
* Excellente maîtrise de l&#039;anglais, allemand un atout
* Bonne maîtrise des logiciels bureautiques
* Rigoureux (se), autonome, esprit d&#039;analyse et doté(e) d&#039;un bon esprit d&#039;équipe]]></description>
<category><![CDATA[QA, QC & Validation]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/health-economics-and-outcomes-research/associate-director-market-pricing-reimbursement/HQ00015201</guid>
<pubDate>Wed, 25 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Associate Director Market Pricing & Reimbursement]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/health-economics-and-outcomes-research/associate-director-market-pricing-reimbursement/HQ00015201</link>
<description><![CDATA[My client is an exciting Global Bio Pharma company who are expanding their Pricing and Reimbursement department due to a strong pipeline.

The function of the role is to 

To implement global strategic pricing plans in conjunction with key stakeholders 
Support Business Unit&#039;s and International Operations through market analysis and provisions of appropriate pricing data in order to support pricing and reimbursement negotiations

Support International through post launch price maintenance strategies once products are in line

* Monitors & evaluates P&R environmental developments in specific Regions or Countries.  
* Maintains & supports an internal network of National P&R negotiators within LOC & Distributors.  
* Works with their internal network to identify & maintain an external panel of national & regional expert Payers to use as a sounding board & provide the &#039;Voice of the Customer&#039;.]]></description>
<category><![CDATA[Health Economics and Outcomes Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/health-economics-and-outcomes-research/associate-director-strategic-pricing-reimbursement/HQ00015205</guid>
<pubDate>Wed, 25 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Associate Director Strategic Pricing & Reimbursement]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/health-economics-and-outcomes-research/associate-director-strategic-pricing-reimbursement/HQ00015205</link>
<description><![CDATA[My client is a leading BioPharmaceutical organisation who are looking for a Pricing and Reimbursement specialist to join their expanding team.

Primary Role
Provide a brief summary describing the major role, responsibilities and purpose of the job.  Summarize key areas of accountability and budget responsibility, if applicable.

For selected developmental products to plan, design and implement global strategic pricing plan in conjunction with key stakeholders including Business Units (BU&#039;s) and Local Operating Companies (LOC&#039;s)

To support selected BU&#039;s  and International  Operations through market analysis and provisions of appropriate pricing & reimbursement data in conjunction with HEOR in order to support pricing and reimbursement negotiations

To work jointly with Senior Director Global Health Economic and Outcome Research ( HEOR) to jointly execute P&R/HEOR activities throughout the product lifecycle

Support Business Development (BD) in providing pricing input for product acquisitions

Works cross functionally on specific therapeutic areas or products to define sales maximizing P&R strategies & evidential requirements.  
Works with HEOR & Market Pricing to support & drive national adaptation in a consistent & credible manner. 
Leads in conjunction with colleagues in Market Pricing & HEOR the development of product specific P&R training, including deployment of negotiation tradables & communication skills for members of the internal P&R networks.  

Responsibilities
Work with BU&#039;s, HEOR & Clinical Development to develop market access plans and shape functional plans to instigate development programs that will adequately demonstrate product effectiveness to reimbursement authorities

Conduct formalized market pricing reviews at key stages of product development cycle (Phase III and Phase III). Incorporate into Strategic Product Plan (SPP)

To support Market pricing by generating data to support product launch and market access strategies through national managed entry programmes

Support licensing/M&A activity through analysis of market data to provide guidance on product pricing

Support Market pricing negotiation process in conjunction with LOC GM and BU, and provide resource as required

Contribute to the design of clinical studies via PST in order to support product value propositions

Network with reimbursement authorities & Key Opinion Leaders to ensure effective presentation of the company&#039;s strategy

Education & Experience Requirements
* Previous experience managing Health Economics function
* Track record in preparing submissions for NICE
* Track record in supporting pricing negotiations for launch product
* Academic credibility via publication
* Established network within International reimbursement authorities
* Qualified in HE

Key Skills and Competencies
* Strategic level thinking
* Clinical experience/expertise
* Extensive expertise in HE
* Strong negotiating skills
* Networking skills
* Ability to serve complex network of internal customers
* Ability to manage/balance differing functional demands
* Strong business acumen
* Judgment and decision making
* Courage to challenge accepted trends]]></description>
<category><![CDATA[Health Economics and Outcomes Research]]></category>
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<guid>http://www.hayspharma.com/jobs/switzerland/regulatory-affairs/regulatory-affairs-manager-centraleastern-europe/HQ00014432</guid>
<pubDate>Tue, 24 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Regulatory Affairs Manager - Central/Eastern Europe]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/regulatory-affairs/regulatory-affairs-manager-centraleastern-europe/HQ00014432</link>
<description><![CDATA[My client is looking for a Regulatory / Pharmaceutical Affairs Manager - Central & Eastern Europe, to ensure the compliance to local regulations and internal procedures of all the activities carried out locally in relation to the commercialization of the products in the countries under the scope of responsibilities as nominated by the Marketing Authority Holder for CEE countries.

Key tasks

1. Leadership function
- Obtain and guarantee the maintenance of the licenses (eg operator, wholesale follow-up) in Central & Eastern Europe countries
- Be the official link with local Regulatory Authorities and Ethics Committees 
* Submission of clinical trial application 
* Ensure compliance with Marketing authorization and Risk management plan (especially Organize, validate and verify the vaccination certificate)
* Participation in local audit
* Manage inspection by Regulatory Authorities
* Follow the administrative work

- Follow-up the CEE countries specific regulatory environment &#039;&#039;intelligence survey&#039;&#039;
- Interface with EMEA HQ Pharmaceutical Affairs for any Regulatory Affairs
- Interface with APIS Quality Assurance for good manufacturing and good distribution related items in designated countries
- Organise local training on SOPs
- Notify in advance local Regulatory Authorities of congresses&#039; sponsorship according to local regulations
- Manage the official &#039;&#039;Transparency Database&#039;&#039; for monitoring the status of the company applications to local Regulatory Authority
- Monitor local the official &#039;&#039;Pharmacovigilance Database&#039;&#039; to control submission of Adverse Drug Reactions (ADR) under the supervision of European Pharmacovigilance (EU QP PV)
- Regularly submit sales results to local Regulatory Authority (if applicable, depending on the country)
- Organize, validate on a pharmaceutical point of view and follow-up the submission of promotional documentation to Regulatory Authority (if applicable, depending on the country)

2. Support function
- Provide input to the finalization of local dossiers (e.g.  pricing, reimbursement) under the supervision of EMEA HQ
·- Approve and validate official local document such as packaging Blue Box.

3. Release function
- Assume the pharmaceutical responsibilities (as &#039;&#039;Qualified Person&#039;&#039;) in accordance with Internal intercompany agreements (QA Agreement, distribution, pharmacovigilance), SOPs, EU directives and local regulations for 
* Safety of the drug in collaboration with the EU QP
* Quality assurance (good manufacturing and distribution practices)
* In collaboration with Global quality group (Product Complaints follow up, Batch recall)
* Promotion documentation validation and Anti-gift law (relationships with healthcare professionals)

Professional requirements

- Pharm. Dipl. or equivalent and as required by local regulations
- Strong experience in Pharmaceutical or Biotechnological industry in similar Regulatory functions
- Strong exposure to CEE countries regulatory requirements, ideally having worked in 2-3 CEE countries
- At ease with managing and developing remotely business relationship with local authorities and key players of each country.
- Willing to work with others as well as independently
- Knowledge of local pharmaceutical regulations and related ethical behaviors
- Understanding of price negotiation and price & reimbursement system is mandatory
- Pharmacovigilance vision is an asset
- Based in Lausanne but prepared to travel extensively (up to 50%) in specific countries
- Fluent in English and German and 1-2 other local languages both spoken and written

Reporting Reporting to the Area Manager CEE and functionally to the Pharmaceutical Affairs Director EMEA]]></description>
<category><![CDATA[Regulatory Affairs]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/marketing-brand-management/emea-marketing-director/HQ00015193</guid>
<pubDate>Tue, 24 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[EMEA Marketing Director]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/marketing-brand-management/emea-marketing-director/HQ00015193</link>
<description><![CDATA[Headquartered in the US, our client are currently developing their EMEA HQ in Switzerland and are a fast-growing and award-winning international medical technology and device company with operations spanning the globe. They have been developing innovative technologies for the past 20 years and keen to expand their operations further. 

EMEA Marketing Director 
The EMEA Marketing Director is responsible for all aspects of strategic and product marketing plan of the company product portfolio. Develops, implements and maintains product marketing plans to exceed units, revenue and profitability goals in key targeted regions. Establishes, implements, and maintains &#039;&#039;best practices&#039;&#039; within the EMEA region. Serves as a critical link between EMEA customers, sales team, with close working collaboration with Corporate Global Marketing. 

Responsibilities 
* Reporting to the EMEA President will be responsible for managing all aspects of EMEA marketing plan to ensure the achievement of financial/budget expectations. Develops and executes annual EMEA marketing plan. 
* Works closely with EMEA regions for marketing activities including pricing strategies, competitive analysis, promotional programs, market research requirements and channel strategies. 
* Effectively communicates business priorities to all functional areas to ensure goals are met. Communicates both short-term and long-term customer needs and sales requirement. 
* Recommends and promotes &#039;&#039;best practices&#039;&#039; including sales strategy, sales tools, and marketing programs, among the regions. 
* Develops strategies and training plans pertaining to new product launches for direct sales force, distributors and customer service. 
* Provides marketing support at conventions, users&#039; meetings, workshops, and other specific marketing functions for both National and International events. 
* Identify optimal marketing mix including trade shows, advertising, direct response&#039;&#039;. 

Requirements 
* BS in business or engineering/science. MBA preferred. 
* Experienced in developing and implementing detailed global product marketing plans with a minimum of 8 years of business experience in the medical device industry. Business experience may include marketing, sales, or business development. Experience in Patient Monitoring industry mandatory. 
* Developed and implemented global marketing strategies. Proven ability in problem identification, analyzing the problem, solution development, and successful implementation. 
* Conducted competitor analysis or profile and market share analysis. Created product training materials and conducted sales training. 
* Responsive to internal and external customers. Possesses knowledge of customer base and customer needs. Travel frequently to assist sales reps in closing key accounts or to build thought leader relationships. 
* French or German language proficiency preferred. 
* 30-40% international travel required.]]></description>
<category><![CDATA[Marketing & Brand Management]]></category>
</item>
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<guid>http://www.hayspharma.com/jobs/switzerland/statistics-sas/scientist-disease-modeling-simulation/HQ00014713</guid>
<pubDate>Tue, 24 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[SCIENTIST, DISEASE MODELING & SIMULATION]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/statistics-sas/scientist-disease-modeling-simulation/HQ00014713</link>
<description><![CDATA[My client a leading a leading international tobacco company is urgently looking for an experienced SCIENTIST, DISEASE MODELING & SIMULATION to join there expanding team. This is a permanent position to be based in Switzerland

KEY RESPONSIBILITIES
- Develop mathematical and computational models of disease mechanisms using multiple approaches and leveraging collaboration partners. 
- Develop hypotheses for disease mechanisms based on the analysis of experimental data in the context of current scientific knowledge 
- Use state of the art software tools to model the causal relationship between individual components within the whole biological system 
- Function as a member of a multidisciplinary  team which executes scientifically challenging projects 
- Have a strong interest in collaboration with biologists for the elucidation of biological mechanisms 

MINIMUM REQUIREMENTS
- Ideally a Ph.D. in Applied Mathematics, Bioengineering, Computational Biology, Physics, or other closely related field with a strong background in nonlinear dynamics, ODEs, and statistics 
- Demonstrated interest and experience in applying your technical knowledge to solve problems in biology and/or medicine. 
- Preferably, you also have domain knowledge in inflammation, cardiovascular disease and/or cancer 
- Able to communicate with scientists in biology and mathematics 
- Familiar with scripting languages 
- Fluency in English is a must]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/principal-statistical-programmer/HQ00014715</guid>
<pubDate>Tue, 24 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Principal Statistical Programmer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/principal-statistical-programmer/HQ00014715</link>
<description><![CDATA[A leading pharmaceutical company currently has urgent requirements for 4 permanent Principal Statistical Programmer. You would be based in there HQ in Switzerland. 

KEY RESPONSIBILITIES

- Coordinate programming activities across several trials and indications with a given compound including publication and regulatory submission activities. 
- Lead the indication/project team including resources planning and coordination of the different programming sites (Basel, India, Japan and US) 
- Make certain that indication/project documents and specifications are consistent and comply with company standards by providing input into Study protocol, CRF and Data structures and outputs (listings, tables and figures) for phase I-IV clinical trials and submission activities. 
- Develop programming specifications for analysis datasets, pooled datasets and deliverables in consultation with the statistician. 
- Develop and comply with project/study programming standards and specifications following internal guidelines. 
- Support quality control and quality audit of deliverables. 
- Participate as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial/project level activities. 
- Track clinical trial milestones for statistical reporting deliverables. 
- Maintain records for all assigned projects and archiving of indication/project analysis and associated documentation. 
- Maintain efficient interfaces with internal and external customers and communicate effectively across line functions. 
- Program according to specifications, analysis datasets, pooled datasets, listings, tables and figures for phase I-IV clinical trials and for SCS and SCE with high quality and within milestones.

Minimum requirements

- Ideally a Bachelor/Master&#039;s degree in Mathematics, Statistics, Data Analysis Program or Computer Science (or equivalent degree with experience). 
- Ability to lead and coordinate programming work across several studies. 
- Solid experience using SAS in the analysis and the reporting of pharmaceutical data 
- Working knowledge and expertise with SAS (including SAS macro language) 
- Strong analytical skills and the ability to think laterally 
- Working knowledge of database design/structures 
- Good understanding of global clinical trial practices, procedures and methodologies. 
- Good understanding of regulatory requirements (e.g. GCP, ICH) 
- Fluent English (oral and written)]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/regulatory-affairs/technical-project-leader/HQ00015475</guid>
<pubDate>Mon, 23 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Technical Project Leader]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/regulatory-affairs/technical-project-leader/HQ00015475</link>
<description><![CDATA[My client is looking for a Technical Project Leader with experience in CMC project and biotech background. You will be responsible for technical project leadership of biopharmaceutical CMC* development projects. Is assigned as Technical Project Leader, to lead the CMC strategy by developing the overall Bx/CMC -project strategies.

Main responsabilities
************************

* Experience with Monoclonal Antibodies, Fusion Proteins, Therapeutic Proteins, Gene Therapy, Somatic Cell Therapy or Medical Devices for Biologicals is desirable
* Formulate the Bx/PSP CMC project strategy, integrate it into project teams. Ensure cooperation with other departments, functions and third parties. Take overall responsibility and lead for Bx/PSP CMC objectives in the project teams
* Elaborate scientifically sound technical development strategies with subteams and project team. Develop contingency plans, compile/maintain Technical Development Plan (TDP) including PSP/BPO/TRD-product strategy
* Assess and plan internal resource needs and negotiate with department(s)/line function for FTEs and external cost (resources), strategies, and timelines for assigned projects. Prepare and monitor project plans and budgets, actively contribute to resource management and ensure timely availability of grants (as appropriate)
* Create, ensure implementation and monitor progress of the respective (technical) development plans. Adapt project strategy and prioritize project activities, according to agreed upon timelines
* Represent Bx/PSP in Due Diligence teams and/or other business initiatives. Participate in strategic initiatives and lead the implementation in the respective departments
* Lead, manage and support the Bx/PSP CMC team(s) and support the respective functional subteam(s) in line with the values. Set priorities for the Bx/PSP CMC team(s), coach, mentor, and motivate subteam members as appropriate and provide input on performance of team and its members, if requested by line functions
* Monitor the preparation and timely availability of all relevant Bx/PSP source documents necessary for regulatory filings and health authority responses, and provide strategic review of relevant CMC documents. Assure cross functional regulatory aspects are covered on International Project Team level etc; participate in regulatory interactions as appropriate 

*Bx The Biologics
CMC Chemistray/Manufacturing/Controls
PSP Protein Science Design
BPO Biopharmaceutical Operations
TRD Technical R&D
FTE Full Time Equivalent

Minimum requirements
****************************
* PhD in Life Sciences with strong background in biotechnology and/or biochemistry;
* Extensive experience in Manufacturing or Development (e.g. several years of experience as head of laboratory), including experienced as a member of functional subteam. 
* Successful performance in the role of leading interdisciplinary teams of scientists working on technical projects
* Excellent English required (oral & written). Good skills in German = bonus (oral)]]></description>
<category><![CDATA[Regulatory Affairs]]></category>
</item>
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<guid>http://www.hayspharma.com/jobs/switzerland/sales-business-development/sales-force-excellence-manager/HQ00014947</guid>
<pubDate>Mon, 23 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Sales Force Excellence Manager]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/sales-business-development/sales-force-excellence-manager/HQ00014947</link>
<description><![CDATA[We are looking for a Sales Force Excellence Manager (m/f) for a permanent position within a global medical device company in West Switzerland. As a senior member of the sales force excellence team within the largest therapeutic are of this company, you will be responsible for the design and Implement this units Sales Force Excellence (SFE) infrastructure for their Europe and Central Asia region. In addition to supporting the Sr. Strategic Marketing Manager in the execution of this strategy, you will also be creating valuable tools for their sales and marketing organizations.
 
For a confidential discussion, please contact Reshma on reshma.nanjappa@hayspharma.com.

DUTIES
- CRM (Salesforce) responsibilities 
- Project manager of initial implementation of CRM 
- Business user and country user coaching and coordination 
- Drive continuous improvement process on CRM tools and implementation 
- Account Segmentation Responsibilities 
- Needs assessment, design, development, implementation and training on aligned account segmentation capabilities for their therapeutic unit.
- Strategic owner of segmentation and management of segmentation tool development and roll-out to the field Interface with Field Force, Country Managers and Business Heads 
- Member of the field advisory boards
 
QUALIFICATIONS
- Master&#039;s degree in related business or other quantitative area of expertise (e.g. Business, Technical/ Engineering) 
- Previous experience and comfort working with online tools or databases 
- Understanding of EFRS system and SAP 
- Business Object usage capabilities 

EXPERIENCE 
- Profound Experience in Sales, Marketing, Sales Force Effectiveness, and/ or Strategy expertise, preferably in the Healthcare Industry 
- Demonstrated field experience in at least one European country preferably working with field-based personnel 

CAPABILITY PREFERENCES 
- Ability to communicate complex concepts to multiple stakeholders in an adaptive manner 
- Able to communicate in at least three European languages 

SPECIFIC SKILLS/COMPETENCIES 
Project management skills 
Strategic perspective 
Cross-functional understanding, communication and alignment skills 
Fluent in English 
Strong analytical skills 
Business acumen 
Relationship building 
Results orientation 

Competitive salary and relocation package are on offer for the right candidate.]]></description>
<category><![CDATA[Sales & Business Development]]></category>
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<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/regulatory-affairs/global-regulatory-director/HQ00014904</guid>
<pubDate>Sun, 22 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Global Regulatory Director]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/regulatory-affairs/global-regulatory-director/HQ00014904</link>
<description><![CDATA[My client is looking for a Global Program Regulatory Director (GPRD) for its Immunology and Infectious Diseases department. You will act as a Global drug regulatory affairs leader of a global program/brand team, which will consist of early phase projects in development and/or foundation projects in full development or foundation brands. 

Functions as a core member of the Global Program Team (GPT) or Global Brand Team (GBT) to define the global regulatory strategy for the development, submission, approval and life cycle management of the project(s) and/or brand(s) in the major and emerging markets. 

Leader of global regulatory team for the program. May also have direct regional responsibilities for one or more of the projects in that program. 

Main tasks and responsibilities:

Regulatory Strategy, HA Interactions, Submissions and Approvals, Prescribing Information, Compliance, Promotional Review and Managerial tasks (Management of direct/indirect reports; leads Drug Regulatory team).


Education and experience:

- PharmD, MD or PhD in Life Sciences, Pharmacy or Medicine, or equivalent experience 

- Languages Fluency in English (oral and written) 

- Some years of involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in most or all of the following areas 
1. Innovation in regulatory strategy. 
2. Prior history with post-marketing/brand optimization strategies and commercial awareness preferred. 
3. Involvement in a CTD/MAA submission and approval. 
4. Leadership role in HA negotiations in multiple regions 
5. Proven success in global drug regulatory submission and commercialization. 
6. Proven ability to analyze and interpret efficacy and safety data. 
7. Regulatory operational expertise. 

- Demonstrated leadership Experience and accomplishment in all aspects of regulatory Affairs in a global/matrix environment in the pharmaceutical industry. 
- Experience in people management required; this may include management in a matrix environment. 
- Global people management experience desirable. 
- Strong management, interpersonal, communication, negotiation and problem solving skills. 
- Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working cross functionally and in global teams.]]></description>
<category><![CDATA[Regulatory Affairs]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/clinical-qa-manager-emea/HQ00014199</guid>
<pubDate>Sun, 22 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Clinical QA Manager EMEA]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/clinical-qa-manager-emea/HQ00014199</link>
<description><![CDATA[My client is a US biotechnology. Due to continued global expansion, they are looking to recruit a Clinical QA Manager EMEA. It&#039;s a permanent position based in Lausanne.

Mission

The Clinical QA Manager develops, implements and leads the clinical quality assurance activities (GCP) and provides quality oversight to help ensure that the clinical research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws, and Company&#039;s established standards and practices in an efficient and expeditious manner.

Key responsibilities

- In agreement with global audit planning Plan, conduct audits to ensure trials conformity to applicable regulations. Audits can include 
 * Clinical investigator sites 
 * Clinical and/or pharmacovigilance systems and/or processes 
 * Regulatory submission related documents (pivotal study reports..)
 * Third party vendors, e.g., CROs, central laboratories, etc.
 * Communicate audit findings, evaluate and follow up on the appropriateness and completeness of corrective action plans until closure.
- Prepare and manage European regulatory inspections. 
- Maintain the global CQA vision and efficiencies of a single system.  
- When needed, develop local SOPs and manage document review and approval processes.
- Conduct cQA training to the organization or to third parties as needed (i.e during clinical investigators&#039; meeting).


Professional Profile

- Must have a University degree in Life sciences.
- Extensive experience within the pharmaceutical industry  in quality assurance, pharmacovigilance, clinical research and drug development, regulatory affairs or regulatory compliance.
- Working knowledge of applicable PV and/or GCP regulations and guidelines.
- Fluency in French and English both written and oral mandatory, good knowledge of other languages is highly desirable.
- Travel required up to 30%.


Personal skills

- Excellent interpersonal skills with a track record of effectiveness as a team leader/player and project team leader/member who gets results.
- Strong ability in influencing others.
- Able to keep the global perspective thinking strategically and act at the operational details level in the same time
- Results focused which may require negotiating skills, empathy, diplomacy, common sense
- Excellent oral and written communication and presentation skills
- Natural flexibility and ability to adapt to changing conditions.
- Team-oriented approach to project management and problem resolution.

You will report to the Pharma Affairs Director, EMEA and functionally through Global cQA]]></description>
<category><![CDATA[QA, QC & Validation]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/qa-qc-validation/plant-engineer/HQ00015470</guid>
<pubDate>Sun, 22 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Plant Engineer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/qa-qc-validation/plant-engineer/HQ00015470</link>
<description><![CDATA[My client, a leading Pharmaceutical company in Basel, Switzerland, is looking for a Plant Engineer to work on an initial 12 month contract

Plant Engineer  BiopharmOps Basel  	

Job Purpose  
Ensures the technical support (repair and maintenance, qualification, improvement) on the production equipment (Fermentation, Chromatography and auxiliary equipment) and infrastructure at BioharmOps Basel according to current GMP, SOP and HSE requirements. 
Main focus on automation and qualification engineering (CSV and mechanical, functional qualification).

Major Accountabilities 
Maintains a functional and qualified condition of the assigned plant and production/lab areas by performing timely maintenance work according to defined maintenance plans and complete documentation according to the current standards.
Ensures the availability of the plant  by applying  spare parts management
Ensures that the assigned plants and production area correspond to the valid GMP regulations and environmental protection guidelines.
Leads technical tasks such as installing, qualification, trouble shooting/root cause finding, repairing and performing preventive maintenance
Optimizes the existing plants regarding state of the art, GMP, security, process-robustness, handling and cost savings
Keeps SOPs and operational procedures up to date which are in context with the technical support responsibilities
Ensures the performance of prospective and retrospective qualification of equipment
Coordinates  the technical support team ( internal and external staff)
Planning, execution of projects 
Ensures a GMP conform deviation handling
Responsible for the ordering-process of technical parts and services in SAP and ePro

Key Performance Indicators 
Job Dimensions 

Number of associatesN.A.		
Financial responsibility (Budget, Cost, Sales, etc.)N.A.		
Impact on the organisation 	Critical technical issues in plant can lead to supply chain and quality risks for the company and patients.	

Ideal Background

Education (minimum/desirable)	
University degree of applied science and technology in the area of automation/electrical engineering, process engineering, biotechnology or equivalent education	
Languages: English	
Experience: Previous experience as an Engineer or Project manager in Pharmaceutical/ biopharmaceutical GMP environment. Experience with electronic, pneumatic and mechanical systems related to a manufacturing equipment.	

Technical / Professional Knowledge and Skills 

Key activities 	
Knowledge of equipment and facility 	
Extensive knowledge of the equipment and facility, Understands the current technologies.		
Process/ -Automation technology and maintenance	
Extensive knowledge of the process-/automation technology and maintenance. 
Recognizes technical opportunities to improve processes and solves problems. Interprets technical data to provide an assessment of their business implications. 		
Regulatory compliance: Extensive knowledge of the relevant guidelines, SOPs and GXP and GSU regarding requirements of technical equipment 		
Project management: Knowledge in leading a project applying project management tools. Manages projects based on technical expertise and capability in accordance with company guidelines assuring optimal cost/time/functionality, quality and sustainability.		

GERMAN IS REQUIRED FOR THIS ROLE]]></description>
<category><![CDATA[QA, QC & Validation]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/health-economics-and-outcomes-research/european-health-outcomes-associate-director/HQ00011937</guid>
<pubDate>Sun, 22 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[European Health Outcomes Associate Director]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/health-economics-and-outcomes-research/european-health-outcomes-associate-director/HQ00011937</link>
<description><![CDATA[The overall objective is to develop & drive the BioScience Health Economic and Reimbursement/Market Access strategy for Region Europe and for Key European subsidiaries to

Support pricing and reimbursement strategies for new and developing technologies and services
In collaboration with market business manager, ensure the successful management of interactions with payers on tenders, HTA&#039;s and other business critical payer threats.
Ensure evaluations of pharmaco-economic and outcomes research required to support these strategies
Working with Govt Affairs and the business influence Governments, Key Opinion 

In more details, he/she will have the following essential duties and responsibilities

Lead the process by which the Region&#039;s and Country&#039;s Health Economic and reimbursement/market access plans are developed and executed.
Lead the identification of European business in terms of pricing, reimbursement and health technology assessment for products in global development, and liaise with global colleagues to ensure global and clinical programmes meet these needs. 
Conduct payer research in Europe to assist Global Development Plans
Work with commercial to develop market access training for all European and country commercial personnel.
Work with the sales and marketing organizations to develop training programs for incorporating economic messages into product detailing in support of the achievement of sales goals and objectives. 

The position reports to the European Health Outcomes Director and is part of the European Government Affairs and Public Policy team.]]></description>
<category><![CDATA[Health Economics and Outcomes Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/clinical-research/registry-project-leader/HQ00015178</guid>
<pubDate>Sat, 21 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Registry Project Leader]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/clinical-research/registry-project-leader/HQ00015178</link>
<description><![CDATA[My client is one of few biopharmaceutical companies to successfully discover, develop and commercialize a first-in-class therapy. They have offices in the US, France, Japan and Australia as well as Switzerland. For their European HQ in Lausanne they are looking for a
Registry Project Leader, Lausanne

Mission

The Registry Project Leader will be in charge of managing my client&#039;s Registry programs and other non-interventional programs in Europe, Middle-East and Africa (EMEA). He/she will support the planning, preparation, execution and management of the assigned programs, coordinating and interacting with various functions within company, and with Contract Research Organizations (CROs) 

Key tasks

The Registry Project Leader will

* Work with the Global and EMEA Clinical Operations teams to plan, track and coordinate the assigned Registry activities in EMEA
* Work with the local offices to prepare the implementation of the assigned Registry in each country
* Communicate effectively with all of my client&#039;s entities and provide regular updates at both local and global levels
* Attend assigned Registry Team regular meetings
* Define and negotiate terms and conditions for outsourcing of clinical trial activities to Contract Research Organizations (CRO) or other external vendors, and track deliverables and performances.
* Assist with and/or lead creation of essential project documents, e.g. protocols, amendments, revised CRFs, informed consents, operation manuals, safety updates and study reports
* Coordinate with Marketing and local offices the preparation, validation and submission (where applicable) of all country-specific documents such as physicians leaflet, patients leaflet…
* Create/revise materials for external/internal communication around the assigned Registry
* Provide training to internal/external stakeholders on assigned Registry materials and procedures
* Check and prepare ethics submission process before implementation in a new country.
* Validate ethics submission when managed by CRO
* Assist Regulatory Affairs when preparing regulatory applications
* Develop/amend country specific physician agreements before validation by Legal Affairs
* Monitor the program timelines, resources and budgets
* Assist with planning, implementation and execution of key project events
* Coordinate Executive Committee/DSMB meeting planning with CRO

Profile

Qualifications/Experience

* BA/BS degree, or equivalent. An advanced degree is preferred
* Solid experience (including monitoring, coordination, project management) in Clinical Research in Biotechnology or Pharmaceutical or CRO, ideally having worked in a matrix environment
* Broad multidisciplinary understanding of the pharmaceutical clinical development processes
* Good knowledge of the EMEA regulatory environment required, understanding of the US environment is a plus
* Excellent knowledge of ICH/GCP and relevant guidelines
* Experience in non-interventional studies and/or patients registries is an asset
* Outstanding clinical management skills are essential
* Computer skills
* Fluency in English both written and oral mandatory
* Fluency in other languages is desirable
* Travel required up to 10%

Personal skills

* Possess excellent interpersonal skills with a track record of effectiveness as a team player and project leader who gets results
* Ability to work independently while seeking advice as required
* Flexibility and ability to adapt to changing conditions
* Excellent problem solving, organizational, and negotiating skills
* Excellent oral and written communication skills in English
* Must demonstrate an energy and enthusiasm which brings a positive approach to all challenges and fosters the idea that nothing is impossible.

Reporting to Director of Clinical Operations, EMEA]]></description>
<category><![CDATA[Clinical Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/marketing-brand-management/director-of-communications/HQ00015170</guid>
<pubDate>Sat, 21 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Director of Communications]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/marketing-brand-management/director-of-communications/HQ00015170</link>
<description><![CDATA[My client, a top 5 pharmaceutical company, is looking to recruit a Director of Communications for its &#039;not-for-profit&#039; operations.  You will work alongside highly intelligent and able individuals, working on cutting edge research and innovation.

For an informal discussion about this position, please contact me on +44(0)207 922 7107 or phil.woodhead@hayspharma.com]]></description>
<category><![CDATA[Marketing & Brand Management]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/statistics-sas/urgent-contract-senior-sas-programmer/HQ00015184</guid>
<pubDate>Sat, 21 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Urgent contract Senior SAS Programmer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/statistics-sas/urgent-contract-senior-sas-programmer/HQ00015184</link>
<description><![CDATA[A leading pharmaceutical company currently has contract opportunities for an experienced SAS Programmer. You would be based in there head office in Switzerland. 

PURPOSE OF ROLE
* Independently, function as a lead statistical programmer coordinating programming aspects for a clinical trial.
* For clinical trials requiring routine or complex data manipulation and analysis, independently program (or write validation programs for) and document tables/listings/figures/analysis datasets.
* For integrated safety and efficacy summaries for regulatory submissions, independently program (or write validation programs for) and document tables/listings/figures/analysis datasets.
* With direction, provide input into general standardization efforts and create (or validate) global macros that streamline repetitive operations
* May administratively and functionally manage up to two statistical programmers with respect to statistical programming strategy, deliverables, processes, and professional development.

Qualifications

* Ideally a BSc or MS (in a numerate discipline, preferably in Statistics, Computer Science, or Mathematics)
* Fluent in English (French or German is a plus)
* Strong  industry experience in the Pharmaceutical/Biotechnology industry in clinical development
* Expertise SAS/BASE, SAS/STAT
* Knowledge of SAS/CONNECT, SAS/MACRO, SAS/GRAPH, SQL
* Knowledge of relevant regulatory guidelines applicable to clinical development
* Familiarization with or ability to develop an understanding of relevant therapeutic areas]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/sas-application-developer-sas-programmer/HQ00015187</guid>
<pubDate>Sat, 21 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[SAS Application Developer/ SAS Programmer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/sas-application-developer-sas-programmer/HQ00015187</link>
<description><![CDATA[FREELANCE urgent SAS Application Developer/ SAS Programmer - Switzerland - Length 6 month contract

PURPOSE OF ROLE

Provide statistical software and software development and documentation support to all groups within the Biometrics Department.

Develop and maintain analysis system tools and requirements with the user community.

Liaise with statisticians and statistical programmers working on early and/or development stage projects and participate in the planning, development, validation, documentation and maintenance of generic tools (across-project programs).

Give advice and provide training on SAS and other software usage and support users in problem solving.

Qualifications and experience

- University education or equivalent with major emphasis on numerate discipline
- Expert knowledge of SAS with UNIX and PC experience
-  Must have experience within the Pharma industry and working experience in application development
- SAS application development experience, especially with standard analysis and reporting tools for regulatory submissions
- SDLC expertise
- Advance software testing/validation skills
- CDISC expertise, SDTM & ADaM data models
- Ability to process information, analyse data, and reach conclusions based on sound reasoning.
- Ensure all statistical elements in clinical studies for the project are managed in accordance with standards agreed (SOPs, TOPs, etc.)
- Ability to work simultaneously on different activities.
- Fluent in the English language]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/scientific-engineering/lean-manager/HQ00015173</guid>
<pubDate>Fri, 20 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Lean Manager]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/scientific-engineering/lean-manager/HQ00015173</link>
<description><![CDATA[Mon client recherche un Lean Manager. Mon client développe, produit et diffuse des médicaments vendus avec ou sans ordonnance, ainsi que des spécialités paramédicales de haute qualité. CDI basé dans la region de Lausanne/Bern en Suisse.

VOS RESPONSABILITES

Vous êtes responsable du développement, de la planification et de la mise en oeuvre de la stratégie Lean dans le service de production et d&#039;ingénierie. De plus, vous êtes chargé de conduire et de superviser les projets d&#039;optimisation. Par la formation et la transmission de la philosophie Lean, vous contribuez de manière décisive à l&#039;établissement et au maintien de la culture Lean dans l&#039;entreprise. Par ailleurs, vous soutenez le service de production et d&#039;ingénierie dans le cadre des projets industriels les plus divers. 

VOTRE PROFIL 

Vous possédez une formation technique ou équivalente et disposez d&#039;une expérience professionnelle conséquente idéalement dans la production industrielle dans le secteur pharmaceutique. Vous avez en outre déjà réalisé avec succès des projets Lean et 6 Sigma et avez de bonnes connaissances dans le domaine des critères de rentabilité et de la gestion de projets. Vous êtes une personne indépendante fortement orientée sur les objectifs et suivez une méthode de travail centrée sur l&#039;efficacité et l&#039;esprit d&#039;équipe. Vous utilisez régulièrement vos bonnes connaissances linguistiques en allemand, en français et en anglais.]]></description>
<category><![CDATA[Scientific & Engineering]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/expert-clinical-manager/HQ00015154</guid>
<pubDate>Thu, 19 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Expert Clinical Manager]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/expert-clinical-manager/HQ00015154</link>
<description><![CDATA[My client is a leading Pharmaceutical company who are looking for an Expert Clinical Manager to work with them on an initial 6 month contract in the Oncology Team.

Responsibilities:
Serves as a Clinical Manager within Oncology	

Reports to:
Clinical Trial Head
	
Key Job Skills:
* BS/BA in Biological Sciences/Nursing/Pharmacy degree 
* A thorough understanding of clinical trial design, in Oncology/ Hematology, trial monitoring practices and all aspects of the drug development process is essential  
* Experience in activities related to interim analysis and data base lock e.g.  data cleaning / clinical data review is a must 
* Ability to coordinate CROs 
* Team player with strong communication skills 
* A thorough knowledge of ICH/GCP guidelines and their impact on all areas of the clinical research process 
* Trial Management, Field monitoring or Data management experience is an advantage 
* Medical scientific writing skills would be an advantage		
		
Desirable Skills	
Some experience in the clinical environment	

Key Behaviours	
* Must have the ability to work independently and collaboratively on a project 
* Effective oral and written communication skills	
		
Start Date		
Immediately]]></description>
<category><![CDATA[Clinical Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/clinical-trial-head/HQ00015157</guid>
<pubDate>Thu, 19 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Clinical Trial Head]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/clinical-trial-head/HQ00015157</link>
<description><![CDATA[My client is a leading Pharmaceutical company who are looking for a Clinical Trial Head to work on an initial 6 month contract based in Basel.

Job Description	
Clinical Trial Head		

Responsibilities	
Serves as a CTH within Oncology		

Reports to	                
CTH Lead (based in US)		

Key Job Skills	
* BS/BA in Biological Sciences/Nursing/Pharmacy degree
* A thorough understanding of clinical trial design, preferably on Oncology/ Hematology, trial monitoring practices and all aspects of the drug development process is essential
* Medical scientific writing skills
* A thorough knowledge of ICH/GCP guidelines and their impact on all areas of the clinical research process.
* Trial Management or Field monitoring experience is an advantage
* Experience in activities related to interim analysis and data base lock e.g.  data cleaning
* Ability to coordinate CROs 		

Desirable Skills	
Experience in the clinical environment and worked as CTH before 		

Key Behaviours	
* Must have the ability to work independently and collaboratively on a project
* Effective oral and written communication skills		

Start Date		
Immediately 		

Length of contract	          
6 months]]></description>
<category><![CDATA[Clinical Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/global-study-leader/HQ00015163</guid>
<pubDate>Thu, 19 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Global Study Leader]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/global-study-leader/HQ00015163</link>
<description><![CDATA[My client is a leading Swiss pharmaceutical company. For their HQ in Basel, they are currently looking to employ a
Global Studies Leader (GSL) 
for a permanent position

Job Description

Location: Basel

Reports to: Study Management Line Manager

Job Purpose

To provide leadership to one or more global Study Management Teams (SMTs) and ensure the effective and efficient 
delivery (leading to and including DRAM specified outputs) of one or more studies in accordance with the Clinical 
Development Plan and ICH/GCP standards.

Principal  Accountabilities and Responsibilities

Provides direction and leadership to one or more SMTs.

Builds effective, high performing SMTs through influence, integration, motivation and optimizing team performance. 
Embeds the Company&#039;s values into the team(s) culture and promotes the team spirit.

Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders and co-
development partners, eg, OPLs, Project Data Managers and non-PDOC functional management.

Represents the SMT(s) at the Clinical Team at the request of the Operations Project Leader (OPL). 

Ensures that each team member is aware of their specific area of responsibility, contribution and participation in the core 
SMT.

In collaboration with functional management, coaches and supports team members to ensure performance is optimized.

Liaises with functional groups to ensure the core SMT(s) receives appropriate study specific training.

Ensures SMT receives therapeutic area training.

Communicates regularly on study(s) status and escalates unresolved issues appropriately to the OPL. 

Develops scenario plans that deliver the studies on time, with the most efficient use of budget and resources.

Maintains awareness of external clinical research practices to ensure the core SMT(s) are aware of the risks, priorities, 
value and impact of their work and contributions.



Establishes study timelines, budget, resource, risk and quality plans

Sets the SMT goals in line with the operational strategy agreed by Clinical and Lifecycle, or Research and Development 
Teams.  Provides coaching to the team to facilitate the setting and achievement of goals.

In accordance with the overall project plan, establishes and maintains accurate study level plans in Pharma Planning 
System, (PPS).

Ensures that milestones are set and managed for the overall studies delivery.

In collaboration with other functional groups,(eg, PDQ) develops and oversees the implementation of the audit, quality, 
risk management and contingency plans within the SMT(s). Ensures that the plans are reviewed, executed and updated 
over the course of the studies.

Leads the development of the protocol feasibility questionnaire with cross-functional input.

Ensures all the relevant functional groups provide input to develop and finalize core study documents including protocol, 
informed consent, CRF and SSPM (study-specific procedures manual).

Oversees the development and active management of the study patient recruitment strategies.

Finalizes country selection for studies across project with consultation from the OPL.           

Oversees the drug supply requirements and availability across studies in liaison with the Global Trial Coordinator.

Ensures that the SMT(s) has the appropriate resources to effectively deliver high quality studies on time and within 
budget. 

Works with Resource Planners to ensure that the SMT(s) is adequately and optimally resourced, and that the study 
resource requirements are planned and contoured accurately in study level plans in PPS.
Oversees the management of the studies budget, with appropriate input from the Global Studies Operations Manager 
(GSOM) to ensure efficient expenditure and minimal variance between actual and planned spend. Reviews accuracy of 
forecasting at RFP rounds and makes adjustments as necessary.
Finalize study budget based upon raw budget estimate from OPL, input from Global Study Operations Manager and in alignment with LCT/CT and 
SMT assumptions. 

Manage the delivery of study activities in order to meet study plans

Monitors progress against SMT goals.  

Chairs core SMT meetings, ensuring minute-taking is rotated and appropriate follow-up is taken on action points.

Organizes agenda and oversees the chairing of investigator meetings and CRO kick off meetings.

Ensures that trial management tracking tools (e.g. AIMS/CTMS) and systems are populated and maintained.

Ensures that data are reviewed in accordance with SMT Data Quality plans. 

Ensures that the SMT(s) complies with GCP regulations and SOPs including essential documentation requirements, etc. 

Oversees the safety reporting activities (including SAE tracking, SDE and SUSAR reporting and provision of safety data 
to external bodies).

Provides direction and oversight of outsourced activities to ensure CRO and vendor delivery against contracted 
scope of work.

Primary point of contact with Business Manager (PDOR).

CRO/CRO partners

Leads the identification, and selection of CRO/CRO partners under guidance of the OPL and Project Data Manager.

Leads the development of the scope of work and is the primary contact for CRO/CRO partner outsourced studies.  
Defines study budget negotiation strategy with the Business Manager. 

Maintains oversight of performance, issues and their resolution to ensure studies are delivered in line with the agreed 
scope of work.

Vendors (e.g. IVRS, Central Laboratory Suppliers)

Leads the identification and selection of vendors.

Provides guidance to the GSOM, ensures appropriate cross-functional SMT input, into the development of the scope of 
work.

Inputs into the contract and budget negotiation led by Business Manager. 

Maintains oversight of performance, issues and their resolution to ensure studies are delivered in line with the agreed 
scope of work. 


Identifies areas of best practice and process improvements.

Leads the evaluation of standards across one or more SMTs with the objective of enhancing quality, productivity and 
efficiency.

Proactively incorporates learnings and recommendations from other study debriefs and best practices.

Contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the 
function.

Maintains oversight and ensures consistency across studies within a project. 

Active contribution to therapeutic area strategy teams (e.g. Oncology Franchise Network).

Leads the SMT Debrief process in consultation with PDOS.

Minimal requirements for position

Life sciences degree or nursing equivalent.

Strong leaderships skills developed through leading global multi-functional matrix study teams through all stages of clinical 
studies and highlighted by a consistent achievement of team delivery against commitments and goals.

Experienced project manager, having led the development and implementation of risk management plans, managed 
complex study budgets and resourcing plans.

Proven experience of all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ 
development team, implementation of clinical development plans and coordinating study level activities to deliver data for 
filing or publication purposes.

Experience of influencing and negotiating at all levels to achieve team delivery.

Self-motivated and achievement driven.

Excellent written and verbal communications skills demonstrated by an ability to present clear messages from complex 
information/data to all levels in the organisation.]]></description>
<category><![CDATA[Clinical Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/clinical-research/clinical-trial-manager/HQ00015428</guid>
<pubDate>Thu, 19 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Clinical Trial Manager]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/clinical-research/clinical-trial-manager/HQ00015428</link>
<description><![CDATA[My client, a leading Geneva based biopharmaceutical company, are currently looking for a 
Clinical Trial Manager
to join their HQ on a permanent basis.
  
PURPOSE OF THE ROLE
 
To drive and manage the conduct of one or more Early development Clinical trials in accordance with the approved Clinical Development Plan (CDP by executing assigned study responsibilities as the Clinical Trial Leader (CTL) or Clinical Research Manager (CRM). The Senior Clinical Project Manager (SCPM) is an expert in the operational execution of clinical trials so that performance expectations are high. SCPMs should act as Clinical Trial Leaders (CTL - see role description) for one or more pivotal studies and as such manage and drive the overall execution of trial team activities in accordance with the approved Clinical Development plan.
 
 
KEY TASKS AND RESPONSIBILITIES
 
 Project Management and Execution
* As assigned CTL - responsible for validation and feasibility assessment of the trials including contingency planning, implementation of rescue strategy where needed, analysis of trial information and feedback to the CDP in order to ensure Go/No go decisions
* Lead and coordinate investigator/site selection and manage/present at Investigator Meetings
* Manage drug supply at trial level and interface with  members of Trial Team and Clinical Supply Chain coordination team
* Define, negotiate and ensure execution of study related SLAs, such as Clinical Trial Agreements, CROS, Central Lab services etc.
* Execute trial level activities in accordance with study objectives, budget objectives and quality objectives in accordance with the approved Study Plan
* Develop study related documents from concept sheets to final study reports
* Liaise with Document Management to ensure maintenance of a compliant Trial Master File
* Review clinical trial data during course of study for safety and data cleaning purposes and during trial analysis and reporting
* Contribute to review, validate and approve Trial Team documents including Statistical Analysis Plan, Data Management Operational Plan, Data Validation Plan, Trial Team Gant etc.
* Act as an interface for regulatory compliance issues
* Manage SAE reporting procedures with  Clinical Safety and Pharmacovigilance
* Feedback knowledge learned during study to Project Team, CMO Organization, Functions, Global Product Development Units
* Maintain excellent scientific and technical knowledge of relevant therapeutic areas and general issues (e.g. critical understanding of laboratory parameters, clinical trial design, compound mechanisms, etc.)
Qualifications
  
CANDIDATE PROFILE
 
EDUCATION/LANGUAGES
* Biological Science/Pharmacy/Nursing degree; advanced degree preferred
* Certification in Clinical Research highly desirable (US, ACRP or other certification)
* Excellent oral and written English; other language(s) an asset

PROFESSIONAL SKILLS AND EXPERIENCE
 
* Solid experience in project management plus several years in related clinical research role (Phases I through IV) in CRO, Pharmaceutical or Biotechnology environment
* Experience in executing a wide range of clinical trial activities (start up through final report)
* Project management including forecasting and budgeting
* Excellent knowledge of clinical trial processes
* Sufficient functional knowledge of Trial Team roles
 
PERSONAL SKILLS AND COMPETENCIES
* Proven Team leadership skills
* Excellent organizational ability
* Excellent communication skills
* Highly self-motivated and proactive
* Flexible]]></description>
<category><![CDATA[Clinical Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/expert-clinical-manager/HQ00015451</guid>
<pubDate>Thu, 19 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Expert Clinical Manager]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/clinical-research/expert-clinical-manager/HQ00015451</link>
<description><![CDATA[My client is a leading Pharmaceutical company based in Basel, Switzerland.  They are looking for an expert clinical manager to work on an initial 6 month contract.  This is to start ASAP.

Responsibilities	
Serves as a Clinical Manager within EGM / Oncology		

Reports  CTH		

Key Job Skills	
* A thorough understanding of clinical trial design, trial monitoring practices and all aspects of the drug development process is essential
* Medical scientific writing skills
* A thorough knowledge of ICH/GCP guidelines and their impact on all areas of the clinical research process.
* Trial Management or Field monitoring experience is an advantage
* Experience in activities related to interim analysis and data base lock e.g.  data cleaning
* Ability to coordinate CROs 

Desirable Skills	
* Scientific background		
* BS/BA in Biological Sciences/Nursing/Pharmacy degree
* Experiance as CRA or in clinical research
* Good computing skills required

Key Behaviours	
* Must have the ability to work independently and collaboratively on a project
* Effective oral and written communication skills		

Start Date: Immediately 		
Length of contract: 6 months]]></description>
<category><![CDATA[Clinical Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/clinical-data-management/data-manager/HQ00015453</guid>
<pubDate>Thu, 19 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Data Manager]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/clinical-data-management/data-manager/HQ00015453</link>
<description><![CDATA[My client a leading pharmaceutical company are looking for a Data Manager for a 6 month contract in Switzerland

As part of this role you will provide timely and professional ongoing management of clinical trial data by identifyingand resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines.

Provide professional DM input on Clinical Trial Team(s)
2. Input to and review of clinical trial database design including User Acceptance
Testing (UAT).
3. Responsible for the Validation and Analysis Plan (VAP) meeting for the clinical
trial, which includes chairing the meeting, writing the study specific validation
checks and necessary reports to ensure high quality and consistent data.
4. Identify errors/inconsistencies and resolve them or initiate their resolution either
via the field monitor or directly with the investigational site, to ensure high quality
and timely database locks.
5. Review and contribute to the preparation of protocols, specifically related to the
data management section, visit schema and study design.
6. Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic
or paper .
7. Support and assist Assistant Data Managers and other Data Managers for allocated
trials.
8. Freeze and lock data as appropriate in time for statistical review, blinded interim
quality review, interim and final database lock.
9. Perform training on the generic electronic database and study specific eCRF to
sites and Novartis personnel at the Investigator meeting for all trials across all
TAs. Travel is required as needed.

The ideal candidate will have experience in all aspects of data management including database lock. Will have experience in VAP, CRF Design, UAT of eCRF and EDC User Training.

If you are interested in this role please feel free to forward an updated CV to leah.crawford@hayspharma.com  or for a confidential discussion please feel free to call me 0044 2079227108]]></description>
<category><![CDATA[Clinical Data Management]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/health-economics-and-outcomes-research/senior-epidemiologist/HQ00015455</guid>
<pubDate>Thu, 19 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior Epidemiologist]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/health-economics-and-outcomes-research/senior-epidemiologist/HQ00015455</link>
<description><![CDATA[A leading Pharmaceutical company has an opportunity for a Senior Epidemiologist to be based in either the UK or Switzerland. This is a permanent opportunity

PURPOSE OF ROLE

* Conduct custom software programming on observational clinical data to generate tables, listings, graphs and other supportive outputs to meet the study and query requirements of Epidemiologists and other customers
* Manage and execute the data analytics process for projects in EpiPRO for Product Development division needs in early and late development projects and in drug safety, clinical science, regulatory, operations, and other functions
* Work under the direction of the Head of the Healthcare Data Strategy and Analytics group, the Data Strategy Lead, Epidemiologists and PRO Specialists in a cross-functional global matrix structure to gather requirements on requests for healthcare data and their associated analytics to support key decision-making points in drug development processes
* Serve as an ambassador with and outside of Product Development to optimize the use and understanding of patient-level clinical, economic and humanistic data. Train internal and external stakeholders on observational data assets 
* Manage outsourcing of analytics work; Validate and QA project work, both internally and externally conducted
* Proactive nature Accountable for Healthcare Data Analysis the tactics for leveraging healthcare data (including external sources of patient and disease-level data) in support of EpiPRO, Biometrics and drug development programs.
* Identify potential sources of healthcare data.
* Gather requirements for the use of healthcare data for applicability to the drug safety, clinical development and marketing partners of EpiPRO.
* Develop and cultivate important professional collaborative relationships with internal partners and stakeholders, including healthcare data institutions, thought leaders and key opinion leaders.
* Assist customers in selecting and working with healthcare data in support of their needs.
* Provide important analyst input into epidemiologist assessment for drug development projects.
* Recommendation-driven Ensures that the objectives, standards, deadlines and other requirements set by management are attained.
* Solutions-oriented Deliver multiple projects and programs on-time, on-target and within-budget.
* Decision-making Identifies improvements in the way observational data are used to support customer needs. Ensures issues are identified, prioritized, and communicated to the appropriate PDI management

Qualifications

* Masters degree or equivalent in Computer Science, Medical Informatics, Outcomes Research, Business Administration or related field. 
* considerable experience in the principles and techniques of data analysis, interpretation, and clinical relevance.
* Ability to process data programmatically through SAS or equivalent programming language, analyze data and reach conclusions based on sound reasoning, medical knowledge and clinical experience.
* Overall knowledge of the Drug Development process, preferably in pharmaceutical clinical research and development.
* Application of logical processes/conceptual thinking/Problem Analysis and Solving.
* Ability to communicate concisely, clearly and accurately in written reports and data, presentations and meetings as required.]]></description>
<category><![CDATA[Health Economics and Outcomes Research]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/principal-statistical-programmer/HQ00015156</guid>
<pubDate>Thu, 19 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Principal Statistical Programmer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/principal-statistical-programmer/HQ00015156</link>
<description><![CDATA[A leading pharmaceutical company currently has an opportunity for an Experienced Principal Statistical Programmer to join there growing team. You would be based in there head office in Switzerland.


PURPOSE OF ROLE

The successful candidate will act as an Indication or Program Programmer for assigned project and will take a programming leadership role on the indication/project team. She/he will be responsible for the following activities 

* Coordinate programming activities across several trials and indications with a given compound including publication and regulatory submission activities. 
* Lead the indication/project team including resources planning and coordination of the different programming sites internationally
* Make certain that indication/project documents and specifications are consistent and comply with company standards by providing input into Study protocol, CRF and Data structures and outputs (listings, tables and figures) for phase I-IV clinical trials and submission activities. 
* Develop programming specifications for analysis datasets, pooled datasets and deliverables in consultation with the statistician. 
* Develop and comply with project/study programming standards and specifications following internal guidelines. 
* Support quality control and quality audit of deliverables. 
* Participate as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial/project level activities. 
* Track clinical trial milestones for statistical reporting deliverables. 
* Maintain records for all assigned projects and archiving of indication/project analysis and associated documentation. 
* Maintain efficient interfaces with internal and external customers and communicate effectively across line functions. 
* Program according to specifications, analysis datasets, pooled datasets, listings, tables and figures for phase I-IV clinical trials 

Qualifications

* Bachelor/Master&#039;s degree in Mathematics, Statistics, Data Analysis Program or Computer Science (or equivalent degree with experience). 
* Ability to lead and coordinate programming work across several studies. 
* Industry experience is a must, using SAS in the analysis and the reporting of pharmaceutical data 
* Working knowledge and expertise with SAS (including SAS macro language) 
* Strong analytical skills and the ability to think laterally 
* Working knowledge of database design/structures 
* Good understanding of global clinical trial practices, procedures and methodologies. 
* Good understanding of regulatory requirements (e.g. GCP, ICH) 
* Fluent English (oral and written)]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/statistics-sas/seniorprincipal-biostatistician/HQ00015421</guid>
<pubDate>Thu, 19 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior/Principal Biostatistician.]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/statistics-sas/seniorprincipal-biostatistician/HQ00015421</link>
<description><![CDATA[A rapidly growing global biopharmaceutical company has a permanent opportunity for a senior/Principal Biostatistician. This is to be based in the French speaking region of Switzerland.

KEY RESPONSIBILITIES

- Discuss, plan and drive the different analysis approaches together with Outcome Survey management and investigators.
- Oversee, construct and develop the analysis data base that based on the information gathered in the application 
- Generate statistical information ensuring accuracy and reproducibility by following relevant working practices
- Provide statistical interpretations and explain statistical methodology
- Interact and interface with customers, medical writers and others when communicating the statistical information. 
- Maintain a high level of professional expertise through familiarity with statistical methodology, current literature and messages from competitors


Education & Experience Requirements

- Masters or PhD degree in Biostatistics or a closely related field.
- 8 years pharmaceutical industry or other relevant experience
- 3+ years of programming in SAS 
- Ability to confidently communicate with and effectively present information to customers, senior management and other departments.
- Strong SAS programming skills using SAS/base, SAS/stat, SAS/graph, and SAS macro.
- Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands. 
- Ability to work independently and oversee deadlines with a high degree of flexibility and commitment.
- Take ownership of projects and moves them forward without supervision
- Ability to take full accountability and ownership of deliverables.
- Actively seeking ways to improve processes and work flow]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/statistics-sas/senior-sas-programmer/HQ00015422</guid>
<pubDate>Thu, 19 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior SAS Programmer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/statistics-sas/senior-sas-programmer/HQ00015422</link>
<description><![CDATA[A rapidly growing global biopharmaceutical company has a permanent opportunity for a Senior SAS Programmer. This is to be based in the French speaking region of Switzerland.

KEY RESPONSIBILITIES

The Senior SAS programmer is accountable for managing the Outcome Survey analysis data bases, development of new reporting applications and providing descriptive statistics, the incumbent is responsible and accountable for that these deliverables meet the expectations. The Senior SAS programmer is also responsible for managing the global macro library and will provide support to Global Outcome Surveys.

- Managing the Outcome surveys analysis data bases and macro library 

- Generate descriptive statistics ensuring accuracy and reproducibility by following relevant working practices and managing the development of new reporting applications. 

- Planning and interacting with the Outcome Survey Biostatisticians 

- Maintain a high level of professional expertise through familiarity with updates in the programming field, current literature and messages from competitors. 

- Interact and interface with the Outcome Survey Biostatisticians, medical writers and others when communicating the descriptive statistic information.


Education & Experience Requirements

- A SAS Certified Advanced Programmer degree or equivalent (SAS/Base, SAS/Advanced, SAS/Macro, SAS/SQL, SAS/Graph and SAS/Effective programming)

- 4+ years as SAS programming in pharmaceutical industry or other relevant experience

- Looking for someone with the ability to work independently and oversee deadlines with a high degree of flexibility and commitment

- This work involves international travel]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/expert-statistician/HQ00014165</guid>
<pubDate>Wed, 18 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Expert Statistician]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/expert-statistician/HQ00014165</link>
<description><![CDATA[A leading pharmaceutical company currently has urgent requirement for a permanent Principal Biostatistician. You would be based in there HQ in Switzerland. 

KEY RESPONSIBILITIES

Provide operational oversight for all deliverables for assigned projects and studies, including full responsibility for timelines and quality standards. Scope of projects may include those in very early phases of development leading up to a proof of concept (PoC), but also the aspects of late phase projects and submissions. 

Provide scientific input and advise to project and study teams, and provide guidance and leadership with respect to innovative approaches to study design and decision making; ensure appropriate involvements of M&S, Statistical Methodology and other internal or external statistical consultants in all assigned projects. 

Contribute to Clinical Development Plans for assigned projects. 

Partner with the project and study teams, and represent Biostatistics in review and decision boards such as protocol review committee and PoC peer review. 

Be accountable to the lead statistician in the respective TA and to the global head of Scientific Support for timeliness and high quality of all IIS/TS deliverables in assigned projects. 

Interact with Health Authorities and external consultants and experts as appropriate. 

Support evaluation of in-licensing opportunities as appropriate. 

Provide technical statistical leadership within the TS/Scientific Support group, and may serve as mentor to more junior members of staff. 

May contribute to major potentially cross-functional initiatives to improve infrastructure and efficiency, or may lead a small initiative herself/himself.

Minimum requirements

University degree in Statistics or Mathematics (Ph.D. or MSc) 
At least five years of relevant experience in the field of clinical trials 
Strong statistical skills and knowledge of clinical trials methodology 
Ideally fluent in English, written and spoken 
Experience gained in all main tasks of a Senior Statistician, and experience as project statistician for international clinical teams or comparable experience in similar ED role. 
Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/Global Clinical Team and the Integrated Information Sciences team. 
Evaluate and explore the implementation of innovative statistical methods to support clinical studies. 
Ensure timeliness and adequate quality of all deliverables for the assigned tasks. 
(SOPs, Master Analysis Plan, GCP, and regulatory guidelines)
Strong knowledge and expertise in statistics and its applications in clinical trials
Experience with implementation of novel methods and/or innovative strategies]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/scientific-engineering/manufacturing-project-leader/HQ00015139</guid>
<pubDate>Wed, 18 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Manufacturing Project Leader]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/scientific-engineering/manufacturing-project-leader/HQ00015139</link>
<description><![CDATA[My client is looking for a Manufacturing Project Leader. My client is a Swiss Biotech Company focusing on the development of vaccines and immunotherapeutic against Alzheimer&#039;s disease. They are seeking an experienced Manufacturing Project Leader to support their product development programs. 

The Manufacturing Project Leader will lead the development and implementation of manufacturing processes for the production of either new biological or entities (NBE) in collaboration with internal labs and external partners (CMO) to timely deliver the required quantities of material for preclinical and/or clinical studies.

Location  Lausanne, Switzerland

Percentage 100% - available immediately

Reporting Line Head of Manufacturing and Project Management


Job Description 
******************

Lead and coordinate the development and implementation of manufacturing processes for the production of NBE. The activities typically encompass mammalian cell-line, cell culture and purification process development, process scale-up, industrialization and implementation for the production of GLP and GMP material.

Qualifications 
******************

The candidate should have the following qualifications

* Graduate degree in Life Sciences subject or Chemical Engineering
* Extensive experience in mammalian cell-line, cell culture and purification process development, scale-up and GxP manufacturing
* Strong experience in CMC project management in the pharmaceutical industry which should cover
* demonstrated ability to plan, coordinate and complete complex CMC projects within agreed budgets and timelines
* demonstrated ability to lead a process development and manufacturing project (team) to success and timely deliver related milestones
* experience in formulation development and/or clinical production and supply would be an asset
* experience in process development for small molecules would be an asset
 
Personal features include
* Ability to communicate clearly and efficiently at all levels, within the company and with external partners
* Ability to integrate and learn fast
* Self motivating
* Team player
* Fluency in English is a must; French and a third language are assets]]></description>
<category><![CDATA[Scientific & Engineering]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/trial-statistician/HQ00014760</guid>
<pubDate>Mon, 16 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Trial Statistician]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/trial-statistician/HQ00014760</link>
<description><![CDATA[A leading international pharmaceutical company has 2 urgent Contract Trial Statistician opportunities to be based in there head office in Switzerland.

KEY RESPONSIBILITIES:

* Responsible for all statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence. For example, clinical trial design/planning, regulatory interactions, analysis plan, reporting activities, CTD and summary documents, exploratory analyses, and statistical consultation.
* May be assigned to lead a small project or parts (e.g., indication(s)) of a project, initially under the supervision/guidance of a more experienced statistician but with increasing autonomy and accountability.
* Track clinical trial/allocated project activities and milestones.
* Interact with the Method group as appropriate.
* Ensure timelines and adequate quality of all Biostatistics and Statistical Reporting (B&SR) deliverables for the assigned trials and project tasks.
* Follow processes and adhere to the clients and project specific standards as well as Health Authority requirements (SOPs, Master Analysis Plan, full development project specifications, and regulatory guidelines).
* Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and B&SR team.
* Participate in or lead non-clinical project activities as needed.

Minimum requirements

*  Master Degree in Statistics (or equivalent degree) with  pharmaceutical experience or PhD in Statistics 
* Experience in all tasks of a Trial Statistician
* Experience in Oncology Statistics and/or regulatory activities would be advantageous
* Fluent English (oral and written)
* Proven knowledge and expertise in statistics and its application to clinical trials
* Proven knowledge of drug development and Health Authority guidelines
* Knowledge of statistical software packages (e.g. SAS, S+)
* Good communication and presentation skills
* Good team player]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/qa-validation-specialist/HQ00014878</guid>
<pubDate>Sun, 15 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[QA Validation Specialist]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/qa-validation-specialist/HQ00014878</link>
<description><![CDATA[My client is looking for a QA Validation Specialist to join the local QA department. You will report into the Compliance Supervisor. This is a permanent position for a large international pharmaceutical company based near Geneva, Switzerland.

Function
Compliance Supervisor / Validation Engineer

Management dimension 
Responsible for QA Validation system and function

Special Issues connected to the Function
Ensure validated status of equipment/systems for the whole manufacturing site.

MAIN TASKS

1.Ensure that qualification and validation standards are met according to the internal procedures and guidelines
2.Review and approve protocols and reports related to qualification and validation activities
3.Establish an assessment of deviations and approval of related action plan
4.Participate in the qualification tests on site and at supplier side
5.Design and review of technical documentation for the purpose of regulatory submission of the products
6.Update procedures related to qualification and validation matters
7.Train employees on qualification, validation principles
8.Train employees on Trackwise modules
9.Handle the change control system and impact assessment on validation status
10.Assess the deviations and change controls for the contractors
11.Be responsible for the coordination of the support documentation room for inspection from clients and health authorities.

QUALIFICATIONS & EXPERIENCE REQUIRED

- Degree level in engineering, technical/scientific qualification
- Some years experience in Validation within the pharmaceutical industry
- Experience in regulatory inspections
- Excellent knowledge of current GMP requirements (ICH, FDA, EU etc.)
- Good management skills in setting direction, motivation and empowering people
- Good communication and interpersonal skills
- Team spirit, flexible and result-oriented

Fluency in French and English]]></description>
<category><![CDATA[QA, QC & Validation]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/sales-business-development/global-drug-supply-chain-manager/HQ00014877</guid>
<pubDate>Sun, 15 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Global Drug Supply Chain Manager]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/sales-business-development/global-drug-supply-chain-manager/HQ00014877</link>
<description><![CDATA[My client is looking for a GLOBAL DRUG SUPPLY CHAIN MANAGER to join the Non-Clinical Development and CMC department. My client is a Swiss pharmaceutical company based in Geneva. You will report into the VP Non-Clinical Development and CMC.
 
Main tasks and responsibilities:

- The Supply Chain Manager will oversee activities related to ensuring drug supply for all on-going and planned world-wide Company clinical trials (Phase I-IV) as well as for all Company product commercialization.  This includes 
- Managing of supply forecasting, labeling, packaging, inventory management and distribution to clinical sites. 
- Managing the supply process for commercial products, in turn dealing with finished products, contract manufacturers, API&#039;s and new market/product launches, as well as all downstream participants in the distribution chain.
- Defining, recommending and implementing the manufacturing and packaging control systems necessary to meet the needs of the Company development and commercial needs to ensure compliant and rigorous supply chains. 
- Interfaces with Clinical Operations and Commercial Operations to assess and determine required quantities of materials and develops supply model to address these needs along with CMC project managers 
- Managing and interfacing with outside CROs and CMOs to ensure bulk drug product and finished dosage form related packaging operations are maintained in compliance with cGMP requirements

EDUCATION and EXPERIENCE:

- Ph.D. or M.S. in Chemistry, Biology, Biochemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field. 
- Strong experience with some years experience in the pharmaceutical supply chain operations, including global clinical/marketed drug management, such as sourcing, inventory control, deployment/logistics and/or product planning 
- Experience managing the supply chain for global Phase I to IV studies including knowledge of International packaging regulations, import/export licensure and drug depot utilization.
- Hands on experience in developing and managing integrated supply chain IT support systems 

ROLE and RESPONSIBILITIES:

- Manage drug supply chain operations including forecasting for all clinical trials, working closely and collaboratively with Clinical Trial Managers and CMC managers.
- Work with Clinical Operation, CMC and Regulatory Affairs to design appropriate labeling, packaging and shipping configurations.
- Be accountable for the scheduling and timely delivery of all necessary clinical supply materials, such as bulk drug, label and packaging inserts, randomization schemes, packaging and shipping configurations, labeling and distribution plans of all portfolio projects
- Direct outsourcing of labeling, packaging and on-time distribution of clinical drug supply to world-wide clinical sites.
- Develop word class processes, and integrated IT support for product launch management, demand planning, logistics and fulfillment.
- Provide support to sales in a variety of areas including sales forecasting, product release schedule, returns, product samples, and other special product requests
- Establish metrics to define supply chain performance and provide recommendations to optimize operations and build the supply chain function 
- Ensure that all supplies are controlled and distributed in accordance with GMP, GLP, GCP and GDP regulations.
- Represent supply chain function on internal and external cross functional teams. 

PERSONNAL ATTRIBUTES:

- Advanced knowledge of labeling, packaging, inventory management and distribution procedures related to clinical/commercial supplies 
- Experience in auditing and managing supply chain and drug packing CMOs. 
- Extensive knowledge of GMP, GLP, GCP and GDP compliance requirements. 
- Deep understanding of drug development and clinical development processes.
- Excellent organizational, planning, communication, negotiation and organization skills. 
- Basic knowledge of clinical protocol design.
- In depth knowledge of state of the art industry supply chain control systems including IT packages 
- In depth knowledge of business related areas project management, contracts, invoicing, and finance
- Complete fluency in English is a must. French is a plus]]></description>
<category><![CDATA[Sales & Business Development]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/qa-compliance-specialist/HQ00014824</guid>
<pubDate>Thu, 12 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[QA Compliance Specialist]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/qa-compliance-specialist/HQ00014824</link>
<description><![CDATA[Entreprise à la pointe de l&#039;innovation biopharmaceutique, avec des racines européennes et active dans plus de 45 pays à travers le monde, mon client recherche un QA Compliance Specialist pour faire face au développement de nos activités sur notre site de production. CDI basé proche Lausanne/Geneve.

Au sein du secteur Compliance du département Assurance-Qualité pour le site de production, vos missions sont les suivantes 
- Assurer la conformité du système qualité aux réglementations internationales applicables ainsi qu&#039;aux procédures internes du groupe
- Implémenter les procédures de qualité (Compliance SOPs)
- Analyse des indicateurs de qualité (KPI) et proposition des plans d&#039;actions 
- Développer, gérer et effectuer les audits assignés (internes, fournisseurs, inspections) 
- Participer activement aux investigations lors de &#039;&#039;complaints&#039;&#039; 
- Participer à l&#039;animation de formations GMP sur le site  
- Participer à la préparation des inspections réglementaires
  
Votre profil:
- Formation universitaire dans le domaine pharmaceutique, chimique, biologique ou équivalent
- Connaissance et pratique approfondies dans le domaine « GMP compliance systems »
- Bonne expérience professionnelle dans un département QA au sein d&#039;une entreprise pharmaceutique
- Expérience dans la préparation et mise en place d&#039;inspections des autorités de santé
- Autonome, dynamique et avec la volonté de s&#039;investir dans une activité en plein essor
- Excellentes compétences en communication et négociation
- Esprit d&#039;entrepreneur, pragmatique, résolument orienté vers les résultats et bon « teamplayer »
- Langue maternelle française avec pratique courante de l&#039;anglais (parlé et écrit)]]></description>
<category><![CDATA[QA, QC & Validation]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/senior-gcp-audit-coordination-manager/HQ00014839</guid>
<pubDate>Thu, 12 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Senior GCP Audit Coordination Manager]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/senior-gcp-audit-coordination-manager/HQ00014839</link>
<description><![CDATA[My client is looking for a Senior GCP Audit Coordination Manager (based in Geneva) for the biopharmaceuticals division. This role is to  support the Head of GCP Audit Management in the planning, development, maintenance, coordination, implementation, tracking and follow-up of the Global R&D Audit Master Plan of Clinical Sites, Vendors and Pharmacovigilance etc ... 

PURPOSE OF THE ROLE

-  Ensure that the audit programs are result-driven and based on a risk management approach for Global Development activities
- Manage the audit team responsible for the development, implementation and follow-up of development of Clinical Sites, Vendors and Pharmacovigilance audit programs
- Ensure that the audit resources and allocation are designed to positively support the achievement of the goals and objectives of the Global Research & Development Quality Assurance
- Encourage and promote quality improvement to maintain fit for purpose quality in the Research & Development organization
- Supports the preparation and follow up of regulatory inspection activities
 
 
KEY TASKS & RESPONSIBILITIES
  
Functional Tasks
 
- Support the Head of GCP Auditing Management in the development, maintenance and tracking of the Global R&D Audit Master Plan functions, including quarterly updates
- Support junior auditors through mentoring, coaching, individualized training and career development
- Manage the audit resourcing and allocation taking into consideration prioritization and risk-management and assurance that they are designed to positively support the achievement of the goals and objectives of the Global Research & Development Quality Assurance
- Ensures the conduct & follow-up of auditing activities related to audits of Clinical Sites, Vendor (In-process),  Pharmacovigilance,
etc ...
  
Managerial Tasks
 
- Lead and motivate direct reports
- Agree on objectives with direct reports in line with the company strategy, and evaluate performance according to company procedures
- Identify, agree and support direct reports&#039; training and development needs directly or indirectly (as appropriate) as well as to set and follow up appropriate plans to support the career development of employees
- Ensure direct reports are trained on appropriate company Policies, Quality Documents, and all job related skills, and that this training is fully documented as applicable
- Together with the Head of the GCP Audit Management, ensure, through an efficient management system, that the skills&#039; pool in the Audit teams are transferable, sustainable to guarantee the versatility, flexibility of the audit resources and assure the successful implementation of the audit program
 
EDUCATION & LANGUAGES
- Life-science degree at a minimum, post-graduate degree in scientific area preferred
- Fluent command of spoken and written English; knowledge of other language(s) such as French and/or German an asset
 
PROFESSIONAL & TECHNICAL SKILLS
 
- Some experience in Good Clinical Practice auditing
- Some People Management experience
- Some experience in clinical development setting in an international pharmaceutical, CRO and/or biotech industry with excellent knowledge of regulatory and business requirements
- In-depth knowledge and expertise of the auditing concepts, approaches and techniques
- Willingness to share and impart knowledge and train, support and mentor more junior auditors
- Creativity, flexibility and openness
- Excellent negotiation and influencing skills with peers and more senior colleagues
- Ability to prioritize and work in a dynamically changing environment]]></description>
<category><![CDATA[QA, QC & Validation]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/gcp-senior-auditor/HQ00011132</guid>
<pubDate>Tue, 10 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[GCP Senior Auditor]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/qa-qc-validation/gcp-senior-auditor/HQ00011132</link>
<description><![CDATA[My client is looking for a GCP Senior Auditor.

Location  Neuchatel, Switzerland 

PREREQUISITES
*********************
- BS in Science or relevant discipline. 
- some years of GCP auditing experience in the pharmaceutical industry or diverse pharmaceutical experience, or demonstration of required skills and knowledge 
- Valid Swiss working permission or EU Citizenship required.

RESPONSIBILITIES
************************
- Maintains current with industry expectations and provides guidance and assistance to ensure the company sustains effective and efficient systems in support of GCP operations 
- Performs audits of processes, clinical documents (CSRs, Protocols, IBs etc.), departments, and systems, internally and externally verses the company Standards and applicable regulatory requirements 
- Participates and supports Regulatory Authority inspections 
- Gives technical guidance and works with junior auditors in GCP training and preparation of audit reports 
- Prepares and reviews audit reports based on audit results 
- Provides guidance and assistance in the development of corrective action commitments and performs regular follow-up 
- Is a mentor to new or less experienced auditors 
- Position requires approx. 40-50% travel 

SKILLS / KNOWLEDGE
***************************** 
- B.S. or B.S./M.S. in Chemistry, Biology, or related fields 
- some auditing or diverse experience in the pharmaceutical industry, or is able to demonstrate required skills and knowledge 
- Performs duties with minimal supervision 
- Current knowledge of applicable regulations from FDA and international agencies 
- Manages complex situations and is effective in influencing compliance decision-making 
- Well developed communication skills (verbal and written) 
- Possesses a high level of maturity and character 
- Extensive acumen in problem solving, managing priorities and a commitment to quality and customer focus]]></description>
<category><![CDATA[QA, QC & Validation]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/principal-statistical-programmer/HQ00014317</guid>
<pubDate>Tue, 10 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Principal Statistical Programmer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland-basel/statistics-sas/principal-statistical-programmer/HQ00014317</link>
<description><![CDATA[A leading international pharmaceutical company has an outstanding opportunity for a permanent Principal Statistical Programmer to be based in there head office in Switzerland.

KEY RESPONSIBILITIES

Responsible for all project level programming aspects (analysis datasets, pooled datasets, listings and tables) for drug project.

- Manage the programming activities for a global project following internal project management guidelines including resource planning.
- Act as Program Programmer for assigned projects and take a programming leadership role on the B&SR project team.
- Maintain efficient interfaces with internal and external customers with advice from SR management.
- Develop and comply with project / study standards and specifications following internal and regulatory guidelines.
- Oversee programming style, quality of SR contributions and compliance with timelines.
- Provide SR input and lead sections of Full Development and Submission Working Groups.
- Ensure that documents and specifications are consistent and comply with company standards by providing input into study protocol, CRF and data structures.
- Program, according to specifications, analysis datasets, pooled datasets, listings, summaries, figures and tables for phase I-IV clinical trials and for SCS and SCE. Ensure quality control and quality audit of deliverables.
- Maintain records for all assigned projects and archive trial / project analysis and associated documentation.
- Participate in the selection of CROs, as required, and supervise SR project activities for CROs.
- Train staff on trial and project level activities and internal processes.
- Participate in or lead non-clinical project activities. for SCS and SCE with high quality and within milestones.

Minimum requirements

- BA/BS or equivalent experience in mathematics, statistics, computer science, life sciences or related field.
- Languages Fluent English (oral and written)
- Expert knowledge of / experience with SAS software
- Good understanding of global clinical trial practices, procedures, methodologies
- Good understanding of regulatory requirements relevant to SR (e.g. GCP, ICH)
- Experience in providing recommendations for maintenance or development of SR global policies, procedures and clinical data presentation standards
- Intermediate knowledge of office tools
- Solid experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/statistics-sas/principal-biostatistician/HQ00014318</guid>
<pubDate>Tue, 10 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Principal Biostatistician]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/statistics-sas/principal-biostatistician/HQ00014318</link>
<description><![CDATA[A leading international pharmaceutical company has 2 urgent permanent Principal Biostatistician opportunities to be based in there head office in Switzerland.

KEY RESPONSIBILITIES

-  Responsible for all statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence. For example, clinical trial design/planning, regulatory interactions, analysis plan, reporting activities, CTD and summary documents, exploratory analyses, and statistical consultation.
-  May be assigned to lead a small project or parts (e.g., indication(s)) of a project, initially under the supervision/guidance of a more experienced statistician but with increasing autonomy and accountability.
- Track clinical trial/allocated project activities and milestones.
- Interact with the Method group as appropriate.
- Ensure timelines and adequate quality of all Biostatistics and Statistical Reporting (B&SR) deliverables for the assigned trials and project tasks.
- Follow processes and adhere to the clients and project specific standards as well as Health Authority requirements (SOPs, Master Analysis Plan, full development project specifications, and regulatory guidelines).
- Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and B&SR team.
- Participate in or lead non-clinical project activities as needed.

Minimum requirements

- Master Degree in Statistics (or equivalent degree) with solid pharmaceutical experience or PhD in Statistics with at least some pharmaceutical experience
- Experience in all tasks of a Trial Statistician
- Experience in Oncology Statistics and/or regulatory activities would be advantageous
- Fluent English (oral and written)
- Proven knowledge and expertise in statistics and its application to clinical trials
- Proven knowledge of drug development and Health Authority guidelines
- Knowledge of statistical software packages (e.g. SAS, S+)
- Good communication and presentation skills
- Good team player]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/statistics-sas/principal-statistical-programmer/HQ00015349</guid>
<pubDate>Tue, 10 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Principal Statistical Programmer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/statistics-sas/principal-statistical-programmer/HQ00015349</link>
<description><![CDATA[My client a leading pharmaceutical company currently has a new opportunity for a Principal Statistical Programmer to join there expanding department. You would be based in there head office in Switzerland. 

PURPOSE OF ROLE

-  Independently, function as a lead statistical programmer coordinating programming aspects for a clinical trial.
- For clinical trials requiring routine or complex data manipulation and analysis, independently program (or write validation programs for) and document tables/listings/figures/analysis datasets.
- For integrated safety and efficacy summaries for regulatory submissions, independently program (or write validation programs for) and document tables/listings/figures/analysis datasets.
- With direction, provide input into general standardization efforts and create (or validate) global macros that streamline repetitive operations
- May administratively and functionally manage up to two statistical programmers with respect to statistical programming strategy, deliverables, processes, and professional development.

Qualifications

- Ideally a BSc or MS (in a numerate discipline, preferably in Statistics, Computer Science, or Mathematics)
- Fluent in English (French or German is a plus)
- Strong  industry experience in the Pharmaceutical/Biotechnology industry in clinical development
- Expertise SAS/BASE, SAS/STAT
- Knowledge of SAS/CONNECT, SAS/MACRO, SAS/GRAPH, SQL
- Knowledge of relevant regulatory guidelines applicable to clinical development
- Familiarization with or ability to develop an understanding of relevant therapeutic areas]]></description>
<category><![CDATA[Statistics & SAS]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/marketing-brand-management/global-medical-marketing-director/HQ00014817</guid>
<pubDate>Sun, 08 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[Global Medical Marketing Director]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/marketing-brand-management/global-medical-marketing-director/HQ00014817</link>
<description><![CDATA[Hays Pharma in Switzerland is looking for its client, bio pharmaceutical company, a Global Medical Marketing Director.  

Reporting to the VP Marketing and Business Development­, you will be in charge of: 

- Focus on the development and implementation of a new product worldwide&#039;s medico-marketing strategy­
- Development and implement of medico-marketing programs to support the launch of a new product (publications, educational programs, treatment guidelines, Key Opinion Leader programs, Advisory Boards, Phase IV study)­
- Providing medical support to the marketing team for the launch of the product (medical input to the marketing and sales support materials) ­
- Maintaining close contacts with the team responsible for development and registration (pre-clinical, manufacturing, clinical, regulatory team) ­
- Establishing and maintaining personal contacts to relevant Key Opinion Leaders in the therapeutic area­

Background and qualifications: 

- Medical Doctor­
- Significant experience in pharmaceutical/biotechnology industry, preferably in medico-marketing ­
- Strong oral and written communication skills ­
- Experienced in new product launch­
­
- Dynamic, results oriented, team player and able to work independently ­
- Strong interpersonal, communication and presentation skills­
- Complete fluency in English is a must. French is a plus­
- Willingness to travel ­
­]]></description>
<category><![CDATA[Marketing & Brand Management]]></category>
</item>
<item>
<guid>http://www.hayspharma.com/jobs/switzerland/statistics-sas/sas-programmer/HQ00015183</guid>
<pubDate>Sun, 08 Aug 2010 23:00:00 GMT</pubDate>
<title><![CDATA[SAS Programmer]]></title>
<link>http://www.hayspharma.com/jobs/switzerland/statistics-sas/sas-programmer/HQ00015183</link>
<description><![CDATA[A leading pharmaceutical company currently has contract opportunities for a number of experienced SAS Programmer. You would be based in the head offices in Switzerland making an impact in the Oncology group.

PURPOSE OF ROLE

-Independently, function as a lead statistical programmer coordinating programming aspects for a clinical trial.

- For clinical trials requiring routine or complex data manipulation and analysis, independently program (or write validation programs for) and document tables/listings/figures/analysis datasets.

- For integrated safety and efficacy summaries for regulatory submissions, independently program (or write validation programs for) and document tables/listings/figures/analysis datasets.

- With direction, provide input into general standardization efforts and create (or validate) global macros that streamline repetitive operations

- May administratively and functionally manage up to two statistical programmers with respect to statistical programming strategy, deliverables, processes, and professional development.

QUALIFICATIONS

- Ideally a BSc or MS (in a numerate discipline, preferably in Statistics, Computer Science, or Mathematics)
- Fluent in English (French or German is a plus)
- Strong  industry experience in the Pharmaceutical/Biotechnology industry in clinical development
- Expertise SAS/BASE, SAS/STAT
- Knowledge of SAS/CONNECT, SAS/MACRO, SAS/GRAPH, SQL
- Knowledge of relevant regulatory guidelines applicable to clinical development
- Familiarization with or ability to develop an understanding of relevant therapeutic areas]]></description>
<category><![CDATA[Statistics & SAS]]></category>
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