Senior Specialist

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.

Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.



Position Description:

The SMA Clinical Q&C Senior Specialist is responsible for the initiation, conduct, and follow-up of audits as assigned by C Q&C Management, including all interaction with involved operational staff (e.g. Project Teams, Clinical Operations, Pharmacovigilance, etc.) within the frame of the mission and responsibilities defined hereafter. This also includes responsibilities as Clinical Project Representative for projects as assigned by C Q&C Management.The position reports to the Director GCP and / or Associate Director GCP.

Duties/Responsibilities
1. Independently prepare, conduct, report, and follow-up on audits according to the SMA Clinical Q&C SOPs, the agreed audit strategy, audit program, and objectives. Audits include project / study related audits, and may also include audits of processes / systems associated with clinical research and pharmacovigilance processes and audits of CROs.
2. Act as a Clinical project Representative (CPR) for assigned clinical projects.
3. May participate in the training on C Q&C activities and other topics related to GCP, Regulations, and Guidelines, etc.
4. Participate in the preparation, implementation and periodic revision of C Q&C SOPs and working methodologies
5. May participate, in liaison with C Q&C Management, in selected Clinical Regulatory Inspections including preparation, escorting inspectors, and communicating information about inspection processes and results.
6. Participate in knowledge updates in areas pertaining to C Q&C and to Regulations / Guidelines / Good Practices through review of literature and participation in relevant internal and external meetings/workshops/symposia.


To Apply Visit Sanofi Aventis

Qualifications:

Knowledge/Skills
- Rigor, diplomacy and integrity
- Good analytical abilities and attention to detail
- Ability to deal with multi-cultural environments- Capacity to work in team oriented environment
- Current regulatory knowledge

Formal Education/Experience

- Bachelor degree in a life / medical / natural sciences or scientific discipline or equivalent
- 6 to 9 years of experience with BA, 4 to 7 years with advanced degree, e.g. MBA, MS, PharmD, PhD. This includes a minimum of 4 years of Clinical Quality Assurance related experience and/or experience in Clinical Trials such as Monitoring or Clinical Trial Management with good performance
- Good working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain (Clinical Development, Pharmacovigilance and Regulatory Affairs)
- Good working knowledge of standard computer office software such as Word, Email system (Outlook, Lotus, etc.), PowerPoint and Excel