JOB SUMMARY：

The MR supports the Clinical Study Directors (CSDs) in the medical supervision and scientific

management of all clinical trials handled by the Clinical & Sciences Operation Platform (CSO) of Sanofi R&D. The primary purpose of the MR position is to operationally support study CSDs on safety and efficacy data medical review and validation.   KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS： Scope of activities include all clinical trials or projects related to clinical development (excluding Phase I in healthy subjects, POC managed by CEP and non Sanofi sponsored studies). Under the guidance of Medical Review Team Leader and following CSDs instructions:he/she collaborates with the Clinical Scientists, CTOMs, Coding specialists/Dictionary Managers, Biostatisticians, TIM (BICC), Pharmacovigilance representatives, Medical Writers on delivering high quality medical data in prespecified timframe, as needed. He/she supports the CSDs to ensure appropriate documentation and consistency of the data and

investigations of safety cases with the Clinical Trial Team or Pharmacovigilance.   KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS：

A. Knowledge And Skills:Medical and Scientific expertise.

High level of autonomy, motivation, good communication skills as well as team player Autonomous, proactive, able to drive an activity until final deliverable Self-motivated & results oriented with attention to detail

Quality focused and well organized.   

B. Formal Education And Experience Required:Medical educational background with M.D. or Master or PhD degree

Physician with clinical practice experience in hospitals at least 1 year Prior to consider previous medical validation/review experience in Clinical Research and/or Clinical DrugDevelopment (e.g., at least 1 year within pharma industry or CRO) Knowledge in ICH, GCP Fluent in English (spoken and written).    C. Knowledge And Skills Desirable But Not Essential:Technical: knowledge in reporting tools and technics              PRINCIPAL DUTIES AND RESPONSIBILITIES (LIST 4-7):1. Conduct medical validation/review tasks directly Execute related tasks taking directions from Team Leader and following CSDs instructions through medical validation/review plan, other type of quality documents, or through direct communication Ensure that activities are conducted in adherence with quality standard, and that deliverables are met, in accordance with CSDs needs, and with respect to study timelines 2. Conduct medical validation/review according to compound safety profile, study population characteristics, study design and efficacy criteria 3. Review/comment/provide input at Medical Validation KOM, Medical review plan KOM. Participate in update of MVP/MRP base on new information during course of study conduct 4. Set up /schedule medical review resolution meetings with CSDs (GSOs ad hoc), Schedule CIOMS/PP review reconciliation meetings with CSDs (CTOMs or CMEs ad hoc) 5. Working with Team Leader, taking into account CSDs’ perspective on the task allocated. Define priorities for the allocated tasks 6. Interact with Team Leader regularly on tasks advancement and completion, difficulties encountered, and potential delays 7. Define timelines for completion of each task, in coordination with team Leader and CSDs 8. Proactively communicate with other functions (eg TO, GPE, CSU, CDOC, TIM (BICC) and so on) to resolve safety data issues timely and effectively.          COMPLEXITY & PROBLEM SOLVING (FORMERLY QUALITATIVE DATA):A. Major Challenges/Problems: List challenges or problems commonly encountered in this job, how they are solved, and with whom they would typically be solved. Meet customer expectation in term of deliverables Deliver on time, according to study timelines, and with high quality Active collaboration with CSDs for developing trust and effectiveness Appropriate and Strategic approach for PP medical review, CIOMS/PP reconciliation, ie., clear understanding of definition of critical data accompanied with clear understanding that non-critical data is “out of medical review scope of work” Productivity development B. Key Internal and External Relationships. Describe the most significant contacts outside the regular work unit. Include frequency and purpose. Medical Validation Team leader, CSDs within OMD&CD, Clinical Scientists, Coding Specialists, CSUs Medical Advisors, GPE: Case Medical Evaluators, PV scientists, Global Safety Officers, CTOMs, Medical writers VI – ACCOUNTABILITY (FORMERLY JOB SCOPE) A. Decision Making Authority: Identify the types of decisions made by this job as well as those that must be referred to a superior (i.e., authority to implement plans, personnel decisions, changes to policy, etc.) Influences - Best approach for study monitoring/conduct - Safety data quality of the studies."