AGM/DGM Medical Writing - Hyderabad

Job Description

Role & responsibilities 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. Required Educational Qualification: MBBS and/or MD (Pharmacology) Work Exp.: MBBS with 10-12 years of experience [OR] MD (Pharmacology) 8-10 years of experience Mandatory Skills Required: Clinical Trails, Protocol Writing, Medical Writing, Investigatioons