ASSISTANT GENERAL MANAGER/DEPUTY GENERAL MANAGER-MEDICAL AFFAIRS

Job Description

Primary responsibilities 1.Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects 2.Development and review clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions etc 3.Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Secondary responsibilities 1.Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans 2.Review of clinical and non-clinical overviews and summaries of CTD 3.Review of medical rationale for CT waiver applications 4.New products evaluation for development 5.Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material 6.Mentoring/ training team members to gain required skills to enable on-time deliverables.