ASSISTANT GENERAL MANAGER/DEPUTY GENERAL MANAGER-MEDICAL AFFAIRS

• Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects
• Development and review clinical documents including protocol, investigator’s brochure, case record form, product rationale, prescribing information, drug interactions etc
• Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals

Secondary Responsibilities

• Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans
• Review of clinical and non-clinical overviews and summaries of CTD
• Review of medical rationale for CT waiver applications
• New products evaluation for development
• Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material
• Mentoring/ training team members to gain required skills to enable on-time deliverables.