Quality Control Specialist, Clinical Documentation

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.This is a position for a person with scientific/medical background and having 3 to 4 years of experience either in Clinical Development or in Quality Control. This person will perform scientific quality control of study reports and other regulatory documents falling under Clinical Documentation responsibility. He/she will work in collaboration with other Quality Control specialists at other sites.Duties and Responsibilities
Contribute within the QC group of Clinical Documentation to the review of scientific content and document format of clinical documents according to medical writer's timelines (CSRs, CTDs, CIBs, IMPD and others). Ensure Clinical Documentation standards by applying departmental procedures and/or checklists. Provide findings and comments related to the review of the document to the responsible medical writer.
As the local QC representative, interface between the local Clinical Documentation group and the worldwide Clinical Documentation QC group by regular participation in site meetings as well as in QC group team meetings and regular telephone conferences. Ensure that the QC process on site meets Clinical Documentation standards.
Participate in improving and streamlining the QC process by identifying,evaluating and assessing trends.
Participate in creation and periodic up-dates of Clinical Documentation QC checklists and QC standards.
Weekly tracking of QC needs on site in order to identify and prevent potential bottlenecks.
Regularly communicate with medical writers and technical editors on quality through site QC training, presentations, information sharing and by providing advice on quality.Major Challenges/Problems
Working in a geographically dispersed team and with people involved in different functions within the Clinical Documentation Department.
Completing the work under time pressure when approaching submissions.Key Internal/External Relationships
External: Clinical Research Organizations.
Internal: Regulatory Affairs and Quality & Compliance.
REQUIREMENTS
Knowledge and Skills
Scientific or medical background.
Good understanding and experience of clinical development (3 to 4 years), either as a Quality Control Specialist or within other functions related to Clinical Development.
Ability to work on multiple tasks and deadline orientated, even under stress.
Capacity to adapt to changing priorities.
Strong ability to organize work with a sense of urgency.
Meticulous and attentive to details.
Strong skills in team work and communication within immediate and extended teams (multicultural, multilingual and multiprofessional).
Must be capable of working independently when needed.
Familiarity with statistics.
Good technical skills (electronic document management system).
High level of English (written/oral).Formal Education/Experience
Scientific degree, Bachelor/Master, in Life Science or medical background.
Work experience (3-4 years for BS, 3 years for MS or medical background candidates) should be in Quality Control or related to Clinical Development, such as for example Clinical Research Associates.Knowledge and Skills Desirable but not Essential
French and/or German desirable.