Medical Writer for Risk Management Plan

Roles & Responsibilities
• Prepare, maintain, and manage Risk Management Plans (RMPs), including schedules, trackers, and submission timelines
• Ensure RMPs reflect current clinical, non-clinical, and post-marketing safety data
• Ensure compliance with EU GVP modules and global regulatory requirements
• Draft and coordinate responses to regulatory authority queries related to RMPs
• Maintain alignment between RMPs and related documents such as PSUR/PBRER, SmPC, Package Leaflet, and Safety Specifications
• Support evaluation and documentation of additional risk minimization measures
• Coordinate cross-functional inputs from Pharmacovigilance, Regulatory Affairs, Clinical, Medical Affairs, and Quality teams
• Ensure version-controlled, SOP-compliant, and inspection-ready documentation
• Support audits, regulatory inspections, and health authority assessments

Qualification
• B.Pharm / B.D.S. / B.A.M.S

Experience
• 3–5 years of experience in RMP authoring or pharmacovigilance medical writing

Skills
• Strong understanding of EU GVP regulations
• Experience with global regulatory safety documentation
• Excellent medical writing, communication, and organizational skills
• Ability to work cross-functionally in a regulated environment

About the Organization
Alkem Laboratories Limited is one of India’s leading multinational pharmaceutical companies, known for its strong presence in branded generics, global regulatory compliance, and commitment to quality healthcare solutions across domestic and international markets.