Medical Writer Risk Management Plan

Position: Medical Writer for Risk Management Plan
About Alkem:

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 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.

Roles and 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.

Education background:  

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

Preferred Experience (Industry/therapy/function no. of years):  3-5 years experience in authoring risk management plans.