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.
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Position Summary
You will lead medical writing activities that support clinical development and regulatory submissions. You will work closely with clinical pharmacology, non-clinical, pre-clinical research, regulatory and biostatistics external partners to plan, author and deliver complex documents. We value explicit scientific judgement, practical project leadership and cooperative communication.
This role offers you with meaningful impact and alignment with our mission of uniting science, technology and talent to get ahead of disease together.
This role will provide you with the prospect to lead key activities to progress your career. These responsibilities include some of the following:
Lead planning, authoring and quality control of early phase clinical and regulatory documents.
Coordinate cross-functional and external input to ensure alignment and regulatory readiness.
Serve as lead author on complex submissions and contribute to submission strategy.
Mentor and coach medical writers and develop training materials for the team.
Identify and implement process improvements to increase quality and efficiency.
Apply digital tools and technology
Responsibilities
Author and review documents including but not limited to Clinical Pharmacology Sections for Regulatory Submissions. Lead the authoring a
📌 Associate Director, Medical Writing Bengaluru
🏢 14260 GSK India Global Services Private
📍 Bengaluru
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