Job Posting: Medical Writer – Risk Management Plan (RMP)

Job Summary

Alkem Laboratories is seeking a detail-oriented and experienced Medical Writer to join our team in Mumbai. This role focuses on the development and management of Risk Management Plans (RMPs) in strict alignment with global pharmacovigilance regulations, including EU GVP guidelines. The ideal candidate will bridge the gap between clinical data, regulatory requirements, and patient safety by collaborating with cross-functional teams. This is a vital position for professionals looking to advance their careers in regulatory medical writing and drug safety documentation within a leading pharmaceutical environment.

Key Responsibilities

As a Medical Writer specializing in RMPs, you will play a critical role in ensuring that our safety documentation meets the highest regulatory standards. Your primary responsibilities will include:

• Document Management: Lead the authoring, review, approval, and submission process for RMP documents while maintaining comprehensive schedules and tracking logs.
• Data Integration: Align RMP content with the latest clinical, non-clinical, and post-marketing safety data to ensure accuracy and scientific integrity.
• Regulatory Compliance: Ensure all documentation adheres to global regulatory frameworks, specifically EU GVP guidelines.
• Regulatory Liaison: Draft and coordinate responses to health authority queries regarding RMPs and support the organization during regulatory inspections, internal audits, and external assessments.
• Cross-Document Consistency: Maintain strict version control and ensure content consistency across related regulatory documents, including PSUR/PBRER, SmPC, Package Leaflets, and Safety Specifications.
• Risk Minimization: Support the evaluation and detailed documentation of additional risk minimization measures.
• Collaboration: Act as a central point of contact for internal stakeholders, including teams from Pharmacovigilance, Regulatory Affairs, Clinical Research, Medical Affairs, and Quality Assurance.
• Documentation Standards: Maintain high-quality, inspection-ready documentation with robust version control and traceability.

Requirements

To be considered for this position, applicants must meet the following educational and professional criteria:

Education:

• Bachelor’s degree in Pharmacy (B.Pharm), Dental Surgery (BDS), or Ayurvedic Medicine and Surgery (BAMS).

Experience:

• 3–5 years of professional experience specifically in the pharmaceutical industry, focusing on:
  • Risk Management Plans (RMP).
  • Pharmacovigilance documentation.
  • Regulatory medical writing.

Preferred Skills:

• In-depth knowledge of EU GVP guidelines and global regulatory requirements.
• Proven ability to handle drug safety documentation and PSUR/PBRER preparation.
• Strong analytical skills with a high level of attention to detail.
• Excellent interpersonal skills, with the ability to coordinate effectively within a cross-functional, multi-disciplinary environment.

Benefits

Alkem Laboratories provides a professional environment that encourages growth and technical development. Joining our team offers:

• Professional Growth: Opportunity to build a career in global pharmacovigilance and regulatory affairs.
• Global Exposure: Hands-on experience with international regulatory submissions and high-stakes safety reporting.
• Collaborative Culture: Direct engagement with senior professionals in clinical and safety teams.
• Competitive Compensation: While salary is commensurate with experience and internal policies, this position typically offers an attractive compensation package in line with current industry standards for specialized medical writers in India.

Job Details

• Position: Medical Writer – Risk Management Plan (RMP)
• Company: Alkem Laboratories
• Location: Mumbai, Maharashtra, India
• Experience Required: 3–5 Years
• Employment Type: Full-time
• Industry: Pharmaceutical & Life Sciences

How to Apply

If you are a dedicated professional looking to contribute to global drug safety and regulatory excellence, we invite you to apply. Please visit the official Alkem Laboratories career portal or our authorized job listing page to submit your resume and cover letter. We encourage candidates to ensure their profiles clearly highlight their experience with RMPs and regulatory medical writing.