GSK looking for Senior Medical Writer

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Post : Senior Medical Writer

Position Summary
The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content. The senior medical writer understands clinical trials design and interpretation of statistically analysed clinical research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments and should be able to meet the quality standards of the global organization. The Senior Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organization

Responsibilities
• Completes assignments independently or for more complex documents, under guidance of a mentor
• Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
• Ensures high integrity of data interpretation, following negotiation with document team.
• Ensures the consistency and quality level of all documents that are issued.
• Actively participates in all planning, coordination and review meetings.
• Ability to work on 2-3 assignments simultaneously.
• Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.
• Works directly with a diversity of roles at different levels within GSK (e.g., Clinical Leads, Asset Leads, Study Delivery Leads (SDL), Biostatisticians, other Medical Writers).
• Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments.

Candidate Profile
PhD or equivalent expertise (e.g., a master’s degree with a minimum of 2 years’ relevant experience) 8 years clinical regulatory writing experience in the pharmaceutical industry

Other Job-Related Skills
• Possesses a good understanding of basic drug development
• Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
• Demonstrates understanding of how to interpret, describe and document clinical data.
• Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
• Possesses necessary computer skills and general computer literacy. Excellent English language skills (verbal and written)

Additional Information
Experience : minimum of 2
Qualification : PhD or equivalent expertise
Location : Bengaluru, India
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 15th October 2026