•As CL (70%):◦Be capable of planning an******** a clinical programleading to regional regulatory submissions. This entails writing theclinical part of the Integrate******** Plan (IDP), protocolExtende******** (ES), briefing package for meeting/consultation with HA,supervising the writing of the full study protocol, writing and/ordirecting Common Technical Document (CTD) clinical mo******** responcesto HA inqurie******** letter in order to surely register the drug withappropriate scientific justifications.
◦To coordinate an******** supervise the conduct of clinical trials incompliance with Sanof******** as well as institutional an********regulations an******** close collaboration with the Clinical StudyDirector (CSD) an******** Clinical Operations Group in order to ensurethe completion of these trials with require******** an******** a timelyfashion. Supervise the writing of the Key Result Memo an******** theClinical Study Report.
◦Serve as medical an******** expert for the clinical programs an********responsible for the ongoing review of clinical trial data as regards toquality an******** accordance with China regulations an********.
◦Select, in collaboration with the Clinical Science & Operationsplatform, the investigator centers participating in these studies.
◦Direct an******** all responses – clinical part - in the building ofregistration dossier in close relationship with the Project Lead,Regulatory Affa******** an******** key contributors.
◦Interact with the Pharmacovigilance department to ensure that theserious adverse events occurring in clinical trials are followe********,evaluated, reporte******** regulatory authorities an******** toinvestigators promptly. Collaborate with Pharmacovigilance in the timelyan******** follow-up of the patient safety (e.g. adverse events) inclinical tr******** ensure the data surveillance plan an******** riskmanagement plan, if any is implemente******** conducted.
◦Participate in written an******** presentations to experts an********,to business partners, an******** regulatory bodies involving discussionof the clinical issues relating to the project.
•As PL (30%)◦Project Strategy:Directs the creation of an IDP totranslate the overall project strategy an******** into an executabledevelopment plan in region an********. Leads the implementation ofcross-functional Project Team at the start of a new project. Uponarrival of new team members, in collaboration with functional managementtrains the team member on project-specific issues an******** optimalintegration into the team.