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Associate Director, Medical Writing

GSK plc
10+ years
INR 40 LPA – 65 LPA
Bangalore, India
1 June 23, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: CPT, HCPCS Level II, ICD-10-CM, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICD-10-PCS, Medical Billing, Medical Coding

Associate Director – Medical Writing

Location: Bengaluru, India
Company: GSK
Department: Medical & Clinical / Clinical Development
Employment Type: Full-Time (On-Site)

Role Summary

The Associate Director – Medical Writing is responsible for leading medical writing activities that support clinical development programs and global regulatory submissions. The role involves strategic planning, authoring, review, quality control, and delivery of complex regulatory and clinical documents while collaborating with Clinical Pharmacology, Regulatory Affairs, Biostatistics, Non-Clinical Research, and external partners.

This position serves as a senior medical writing leader, contributing to submission strategy, mentoring medical writers, driving process improvements, and ensuring delivery of high-quality regulatory documentation aligned with global standards.

Key Responsibilities

Medical & Regulatory Writing

  • Lead authoring and review of:

    • Clinical Pharmacology Sections

    • Regulatory Submission Documents

    • Clinical Study Reports (CSRs)

    • Clinical Protocols

    • Briefing Documents

    • Submission Modules

  • Develop:

    • Module 2.7.1 (Summary of Biopharmaceutics)

    • Module 2.7.2 (Summary of Clinical Pharmacology Studies)

  • Ensure scientific accuracy and regulatory compliance.

Submission Strategy & Regulatory Support

  • Serve as Lead Author for complex global submissions.

  • Contribute to regulatory submission strategies.

  • Support preparation of regulatory documentation for health authority interactions.

  • Ensure submission readiness and document quality.

Project Leadership

  • Lead planning and execution of multiple writing projects.

  • Maintain document trackers and project timelines.

  • Identify and mitigate risks impacting deliverables.

  • Coordinate review and approval processes.

Cross-Functional Collaboration

  • Collaborate with:

    • Clinical Pharmacology Teams

    • Regulatory Affairs

    • Biostatisticians

    • Non-Clinical Teams

    • Clinical Development Teams

    • External Vendors

    • Global Stakeholders

  • Build strong partnerships within matrix organizations.

Quality Management

  • Ensure compliance with:

    • Regulatory Guidelines

    • Internal SOPs

    • Quality Standards

    • Submission Requirements

  • Perform quality review and scientific validation of documents.

Mentoring & Capability Building

  • Mentor and coach Medical Writers.

  • Develop training materials and knowledge-sharing resources.

  • Support professional development within the writing team.

  • Promote best practices in scientific and regulatory writing.

Process Improvement & Innovation

  • Identify opportunities to improve writing processes.

  • Implement efficiency and quality enhancement initiatives.

  • Utilize digital tools and technology to optimize document development.

Required Qualifications

Education

  • PhD / MD / PharmD / M.Pharm / M.Sc or equivalent in:

    • Life Sciences

    • Pharmacy

    • Pharmacology

    • Biotechnology

    • Medical Sciences

    • Clinical Research

    • Related Scientific Discipline

Experience

  • 10+ years of Medical Writing experience.

  • Strong experience in Early-Phase Clinical Development.

  • Experience authoring:

    • Clinical Pharmacology Documents

    • Regulatory Submission Documents

    • Clinical Study Reports

    • Protocols

    • CTD Modules

  • Experience working in global matrix organizations.

  • Experience managing external vendors and stakeholders.