Senior Medical Writer
ROLE OVERVIEW
GSK is a global biopharmaceutical leader focused on vaccines and specialty medicines across respiratory, immunology, oncology, HIV and infectious diseases. The Senior Medical Writer in Bengaluru sits within a high-impact R&D documentation function that translates complex clinical and regulatory data into clear, compliant submissions. This role directly supports protocols, clinical study reports, CTD modules, investigator brochures and health-authority responses, making it central to accelerating GSK's pipeline and patient access. Working in a global matrix with clinical leads, biostatisticians and asset teams, the writer ensures scientific integrity and timely delivery. For experienced medical writers, this is a compelling opportunity to deepen regulatory writing expertise, collaborate across therapeutic areas, and contribute to medicines and vaccines that impact billions. GSK's culture of ambition for patients, accountability and inclusion further makes this a strong career platform in India's fast-growing biopharma sector.
ROLE DEFINITION & RESPONSIBILITIES
- •Independently author clinical and regulatory documents using GSK templates, including protocols, clinical study reports, investigator brochures, briefing documents and CTD submission modules.
- •Prepare IND, NDA, MAA and IMPD sections with accurate, consistent interpretation of statistically analysed clinical research data.
- •Coordinate with Clinical Leads, Asset Leads, Study Delivery Leads and Biostatisticians to align document content with program strategy.
- •Draft responses to regulatory authority questions and support submission-ready formatting, quality checks and version control.
- •Manage two to three concurrent writing assignments while protecting quality, timelines and compliance with ICH-GCP.
- •Participate in planning, coordination and review meetings, raising data or document issues constructively and recommending alternatives.
- •Maintain high medical writing standards, ensuring consistency, accuracy and integrity across all deliverables.
- •Build effective communication networks across global stakeholders to support smooth delivery and continuous process improvement.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- PhD or equivalent expertise; master's degree with at least 2 years of relevant clinical regulatory writing experience.
- Up to 5 years of clinical regulatory writing experience in the pharmaceutical, biotech or CRO industry.
- Good understanding of drug development, scientific methodology and statistical principles in clinical research.
- Proven ability to interpret, describe and document clinical data accurately for regulatory and clinical audiences.
- Working knowledge of ICH-GCP requirements and regulatory submission standards.
- Strong computer literacy, including document management and collaborative authoring tools.
- Excellent written and verbal English communication skills for global cross-functional work.
PREFERRED QUALIFICATIONS
- •Experience in vaccines, oncology, immunology or HIV therapeutic areas
- •Working knowledge of Veeva Vault RIM or similar regulatory document systems
- •Prior exposure to global health authority interactions (FDA, EMA, MHRA)
- •Publication writing or medical communications experience
- •Project management certification or formal writing qualification
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
GSK (GlaxoSmithKline) is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. The company focuses on the research, development, and manufacture of innovative vaccines and specialty medicines. GSK's products address a wide range of diseases, aiming to impact the health of millions worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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