Medical Writer Job at Alkem Laboratories | Apply Now
If you are looking for a specialized writer job in the pharmaceutical industry, Alkem Laboratories Ltd. is hiring a Medical Writer for Risk Management Plan activities. This opportunity is ideal for professionals with experience in pharmacovigilance documentation and regulatory compliance who want to build a strong career with Alkem Laboratories in Mumbai, especially for candidates from pharmacy and clinical backgrounds, including BDS jobs.
Job Details:Â
- Job Position: Medical Writer – Risk Management Plan
- Location: Mumbai
About the Company:
Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai that manufactures and sells pharmaceutical generics, formulations, and nutraceuticals in India and globally in over 50 countries. We have consistently been ranked amongst the top five pharmaceutical companies in India. Our portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O, which feature amongst the top 50 pharmaceutical brands in India.
Job Description:
Alkem Laboratories Ltd. is hiring for a writer job focused on Risk Management Plan (RMP) authoring and lifecycle management. The role involves preparing, maintaining, and managing RMPs while ensuring regulatory compliance, safety data alignment, and coordination with cross-functional teams. This position is suitable for candidates seeking long-term growth in Alkem Laboratories through regulated medical writing roles.
Qualifications:
-
B.D.S
Preferred Experience:
- 3–5 years of experience in authoring risk management plans
- Industry experience in pharmacovigilance, regulatory writing, or safety documentation preferred
Key Responsibilities:
- Prepare, maintain, and manage risk management plan (RMP) schedules, timelines, and trackers to ensure timely authoring, review, approval, and submission of RMP.
- Ensure that RMPs accurately reflect the current safety profile of products and are aligned with available clinical, non-clinical, and post-marketing safety data.
- Ensure all RMPs are compliant with applicable global and regional regulatory requirements, including EU GVP and relevant health authority guidance.
- Draft, coordinate, and support responses to regulatory authority queries and requests for clarification related to RMP content.
- Maintain consistency and alignment between RMPs and related safety and regulatory documents, including PSUR/PBRER, SmPC, Package Leaflet, and Safety Specifications where applicable.
- Support the evaluation, justification, and documentation of additional risk minimization measures, including routine and additional risk minimization activities, when required.
- Coordinate cross-functional data inputs and document review cycles to ensure timely finalization and submission of RMPs.
- Ensure all RMPs are inspection-ready, fully traceable, version-controlled, and compliant with internal SOPs and quality standards.
- Support internal audits, regulatory inspections, and health authority assessments related to Risk Management Plan activities.
- Liaise effectively with cross-functional stakeholders, including Pharmacovigilance, Regulatory Affairs, Clinical, Medical Affairs, Quality, and relevant business functions, to gather accurate inputs for comprehensive and compliant RMP preparation.
