Primary responsibilities1.Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects2.Development and review clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions etc3.Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals

Secondary responsibilities1.Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans2.Review of clinical and non-clinical overviews and summaries of CTD3.Review of medical rationale for CT waiver applications4.Current products evaluation for development5.Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material6.Mentoring/ training team members to gain required skills to enable on-time deliverables.

📌 Assistant General Manager/Deputy General Manager-Medical Affairs (Hyderabad)
🏢 Hetero
📍 Hyderabad