Principal Medical Writer
📍 Locations:
Bengaluru Luxor North Tower, India
Mississauga Milverton Drive, Canada
🏢 Category: Medical and Clinical
🆔 Job ID: 428769
📅 Posted Date: October 16, 2025
Business Introduction
GSK is a global biopharma company with the ambition 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 deep understanding of the immune system with cutting-edge technology.
We foster a culture that is:
Ambitious for patients
Accountable for impact
Committed to doing the right thing
Our aim is to accelerate significant assets that meet patient needs with the highest probability of success.
Job Purpose
The Principal Medical Writer is an expert contributor responsible for independently executing complex medical writing assignments. This role involves:
Drafting, reviewing, and approving clinical documents, including marketing application submission documents.
Planning and prioritizing work without supervision.
Supporting continuous improvement and implementing best practices in clinical documentation.
Key Responsibilities
Write clinical regulatory documents including: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
Collaborate in matrix teams to deliver high-quality, fit-for-purpose documents aligned with GSK standards and regulatory requirements.
Contribute to the planning and production of clinical dossiers for regulatory submissions worldwide.
Manage projects of increasing scope and complexity effectively.
Understand interdependencies among various functions (e.g., clinical pharmacology, biomarkers, health outcomes).
Assess complex situations and apply scientific, operational, and regulatory knowledge to implement solutions.
Interpret complex clinical and statistical data and organize content effectively.
Review reporting and analysis plans, providing input on the content and presentation of tables.
Utilize tools and automation to expedite document preparation.
Adjust priorities and behavior based on changing requirements or therapeutic areas.
Demonstrate effective oral and written communication skills.
Education Requirements
PhD in a relevant life sciences field or equivalent working experience.
Job-Related Experience
Experience in clinical regulatory writing within the pharmaceutical industry.
Demonstrated leadership skills.
Experience in multicultural and remote team settings.
Ability to interpret, describe, and document clinical data.
Working knowledge of ICH/GCP guidelines.
Computer literacy and proficiency in relevant software tools.
Excellent English communication skills (verbal and written).
Why GSK?
GSK unites science, technology, and talent to get ahead of disease together.
Focused on impacting 2.5 billion people by the end of the decade.
Operates in respiratory, immunology & inflammation, oncology, HIV, and infectious diseases.
Promotes a culture where people thrive, with ambition, accountability, and ethical practices.
Inclusion & Accessibility
GSK encourages candidates to request recruitment process adjustments if needed.
Contact: IN.recruitment-adjustments@gsk.com
Important Notices
GSK does not accept referrals from agencies without prior written authorization.
Beware of fraudulent job postings; only trust emails ending in @gsk.com.
GSK recruitment is free of charge.
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