Alkem Laboratories Limited, one of India’s top-ranked multinational pharmaceutical companies, is hiring a Medical Writer for Risk Management Plan (RMP) at its Mumbai location. This full-time, on-site opportunity is ideal for professionals with experience in pharmacovigilance medical writing, RMP authoring, and regulatory safety documentation.
If you are seeking a career in drug safety writing, EU GVP-compliant RMP preparation, and global regulatory documentation, this role offers excellent exposure and long-term growth within a reputed organization.
🔹 About Alkem Laboratories Ltd.
Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, with a presence in over 50 countries. Known for leading brands such as Clavam, Pan, Pan-D, and Taxim-O, Alkem consistently ranks among the top five pharmaceutical companies in India.
📌 Job Title
Medical Writer – Risk Management Plan (RMP)
Location: Mumbai, Maharashtra, India
Employment Type: Full-Time | On-site
🧾 Key Responsibilities
- Prepare, maintain, and manage Risk Management Plans (RMPs) including schedules, trackers, and submission timelines.
- Ensure RMPs accurately reflect current clinical, non-clinical, and post-marketing safety data.
- Ensure compliance with EU GVP modules and global regulatory guidelines.
- 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 PV, Regulatory Affairs, Clinical, Medical Affairs, and Quality teams.
- Ensure inspection-ready, version-controlled, and SOP-compliant documentation.
- Support audits, regulatory inspections, and health authority assessments.
🎓 Qualifications & Experience
Education:
- B.Pharm / B.D.S. / B.A.M.S
Experience:
- 3–5 years of experience in RMP authoring / pharmacovigilance medical writing
Preferred Skills:
- Strong understanding of EU GVP regulations
- Experience with regulatory safety documents
- Excellent writing, communication, and organizational skills
💼 Salary & Benefits (Indicative)
- ₹7,00,000 – ₹12,00,000 per annum (depending on experience)
- Health insurance & medical benefits
- Learning & development opportunities
- Career growth in global pharmacovigilance
📨 How to Apply
