Senior Medical Writer – Clinical & Regulatory Writing
Company: GSK (GlaxoSmithKline)
Job Requisition ID: 434146
Employment Type: Full-Time
Work Model: Hybrid
Locations: Bengaluru, India | Mississauga, Canada
Application Deadline: January 30, 2026
Experience Required: Up to 5 years
About GSK
GSK is a global biopharmaceutical company committed to uniting science, technology, and talent to get ahead of disease together. With a bold ambition to positively impact the health of 2.5 billion people by the end of the decade, GSK focuses on discovering and delivering innovative vaccines and medicines across key therapeutic areas including respiratory, immunology, oncology, HIV, and infectious diseases.
Driven by a culture that is ambitious for patients, accountable for impact, and grounded in ethical responsibility, GSK offers a collaborative environment where scientific excellence and patient outcomes remain at the forefront.
Job Overview
GSK is seeking a Senior Medical Writer to support the development of high-quality clinical and regulatory documents across the drug development lifecycle. This role requires strong expertise in clinical trial documentation, regulatory writing, and interpretation of clinical data. The Senior Medical Writer will independently manage complex writing assignments, coordinate cross-functional stakeholders, and ensure timely delivery of compliant, submission-ready documents within a global matrix organization.
Key Responsibilities
Author and deliver a broad range of clinical and regulatory documents, including but not limited to clinical protocols, clinical study reports (CSRs), Investigator’s Brochures, briefing documents, CTD modules for NDA/MAA submissions, and responses to regulatory authority queries
Independently manage writing assignments or complex documents under mentor guidance, ensuring adherence to quality and compliance standards
Interpret and present clinical safety and efficacy data accurately, ensuring data integrity and scientific consistency
Coordinate cross-functional review processes involving clinical leads, biostatisticians, study delivery teams, and regulatory stakeholders
Ensure consistency, clarity, and accuracy across all assigned documents
Participate actively in planning, coordination, and document review meetings
Manage multiple writing assignments concurrently while meeting project timelines
Proactively identify content gaps, risks, or inconsistencies and propose scientifically sound solutions
Maintain strong collaboration across global teams to support efficient document development and approval workflows
Required Qualifications
Education: Master’s degree or higher in Life Sciences, Pharmacy, Medicine, or a related scientific discipline
Experience: Up to 5 years of clinical and regulatory medical writing experience within the pharmaceutical or biopharmaceutical industry
Proven experience authoring regulatory documents such as CSRs, clinical summaries, and clinical overviews
Strong understanding of clinical trial design, data analysis, and interpretation of safety and efficacy outcomes
Excellent written and verbal English communication skills
Ability to work effectively within complex, global matrix environments while managing multiple priorities
Preferred Qualifications
Working knowledge of drug development processes
Understanding of scientific methodology and statistical principles in clinical research
Familiarity with interpretation and documentation of clinical data
Knowledge of ICH guidelines and Good Clinical Practice (GCP) requirements
Working Model
This is a hybrid role based in India, offering a combination of on-site collaboration and flexible remote working to support focused writing activities.
Compensation (Location-Specific)
In compliance with regional pay transparency regulations, the annual compensation range for this role in Canada is CAD 103,000 – CAD 153,000, determined based on experience, qualifications, and internal equity. Compensation details for other locations will be discussed during the recruitment process.
Why Join GSK
Be part of a global organization shaping the future of vaccines and specialty medicines
Work in a science-driven, patient-focused environment
Collaborate with global experts across clinical, regulatory, and scientific disciplines
Access continuous professional development and career growth opportunities
Contribute directly to improving global public health outcomes
Inclusion & Accessibility
GSK is committed to fostering an inclusive workplace. Reasonable accommodations are available throughout the recruitment process upon request.
Important Notice
GSK does not charge any fees at any stage of the recruitment process. Candidates are advised to remain vigilant against fraudulent job advertisements or communications not originating from official GSK email domains.
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