Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D; focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D;
Position Summary
The Senior Medical Writer is responsible for independently developing high-quality clinical and regulatory documents, seeking guidance from mentor for complex assignments as appropriate. The role requires solid knowledge of clinical trial design, interpretation of statistically analysed clinical research data,
and effective coordination across global stakeholders to ensure timely, accurate, and compliant deliverables within a complex matrix organization.
Key Responsibilities
Prepare a range of clinical and regulatory documents using defined templates, including protocols, clinical study reports, IND/NDA/MAA CTD and IMPD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
Complete assignments independently, seeking mentor guidance as appropriate for complex documents.
Ensure accurate, consistent, and high-integrity interpretation of clinical data in collaboration with the document team.
Maintain consistent quality standards across all documents.
Participate actively in planning, coordination, and review meetings to support timely document delivery.
Manage two to three assignments simultaneously while maintaining quality and timelines.
Identify and discuss concerns in a timely and constructive manner w
📌 Senior Medical Writer (Bengaluru)
🏢 GSK
📍 Bengaluru