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 Principal Medical Writer independently leads the preparation of complex clinical and regulatory documents, ensuring high quality, scientific accuracy, and compliance with applicable standards and regulatory requirements.

Responsibilities
Lead development of key clinical and regulatory documents, including protocols, informed consent forms, clinical study reports,



submission documents and regulatory responses.
Interpret clinical and statistical data and present transparent, accurate scientific messages.
Collaborate with cross-functional matrix teams and manage writing assignments with minimal supervision while ensuring the documents meet GSK and global standards.
Support process improvement initiatives, and mentoring of junior writers.

Basic Qualification
PhD or equivalent expertise with relevant experience; preferably at least 5 years of clinical regulatory writing experience in the pharmaceutical industry.
Solid knowledge of regulatory writing, drug development, clinical research methodology, statistics, ICH-GCP.
Excellent ability to interpret clinical data and communicate clearly in written and verbal English.
Strong computer literacy and ability to use relevant document preparation and review tools.
Key Skills and Capabilities
Robust st

📌 Principal Medical Writer Bengaluru
🏢 GSK
📍 Bengaluru