Senior Medical Writer
Locations: Bengaluru, Karnataka, India | Mississauga, Ontario, Canada
Employment Type: Full Time
Function: Medical & Clinical | Medical Writing
Industry: Biopharmaceuticals
Job ID: 434146
Posted Date: January 23, 2026
Work Sites: Bengaluru – Luxor North Tower | Mississauga – Milverton Drive
About GSK
GSK is a global biopharmaceutical organization dedicated 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 the discovery and development of innovative vaccines and medicines across key therapeutic areas, including respiratory, immunology, oncology, HIV, and infectious diseases.
Role Overview
The Senior Medical Writer is a key contributor within GSK’s Research & Development organization, responsible for independently authoring and coordinating complex clinical and regulatory documents. This role requires a strong understanding of clinical trial design, statistical data interpretation, and global regulatory standards.
The position involves close collaboration with cross-functional stakeholders in a complex matrix environment and accountability for delivering high-quality, submission-ready documents that meet global regulatory and organizational standards.
Key Responsibilities
Medical & Regulatory Writing
Independently author and manage complex clinical and regulatory documents under limited supervision.
Prepare a wide range of documents, including clinical trial protocols, clinical study reports (CSRs), investigator brochures, briefing documents, NDA/MAA CTD submission modules, and responses to regulatory authority questions.
Ensure scientific accuracy, data integrity, and consistency across all assigned documents.
Interpret and present statistically analyzed clinical data related to safety and efficacy in a clear, compliant manner.
Cross-Functional Collaboration
Coordinate effectively with Clinical Leads, Asset Leads, Study Delivery Leads, Biostatisticians, and other Medical Writers to gather input and align content.
Actively participate in planning, review, and coordination meetings to ensure timely delivery of writing assignments.
Build and maintain strong communication networks to facilitate efficient document development and review cycles.
Quality & Process Excellence
Uphold global medical writing quality standards and proactively identify gaps or issues, proposing appropriate solutions.
Manage multiple writing assignments simultaneously while meeting project timelines and quality expectations.
Take ownership of final deliverables and ensure compliance with ICH, GCP, and internal standards.
Education & Experience Requirements
Educational Qualifications
Master’s degree or higher in Life Sciences, Pharmacy, Medicine, or a related scientific discipline (mandatory).
Experience Required
Up to 5 years of experience in clinical and regulatory medical writing within the pharmaceutical or biopharmaceutical industry.
Proven experience authoring clinical regulatory documents, including CSRs, clinical summaries, and overviews.
Strong understanding of clinical trial design, drug development processes, and interpretation of clinical data.
Technical & Professional Skills
Excellent written and verbal English communication skills.
Demonstrated ability to interpret, analyze, and document clinical safety and efficacy data.
Working knowledge of ICH guidelines and Good Clinical Practice (GCP).
Familiarity with scientific methodology and basic statistical principles applied to clinical research.
Ability to manage multiple priorities effectively in a global, matrixed organization.
Work Model
This is a hybrid role, based primarily in India, requiring regular in-office collaboration alongside flexible remote working for focused writing activities.
Compensation Transparency
In compliance with regional pay transparency regulations, the annual compensation range for the Mississauga, Canada location is CAD 103,000 to CAD 153,000, based on experience, qualifications, and internal equity. Salary ranges for other locations may vary and will be discussed during the recruitment process where applicable.
Why Join GSK
Competitive base salary with performance-based annual bonus
Flexible and hybrid working options
Comprehensive healthcare and wellbeing programs
Continuous learning, development, and career advancement opportunities
Inclusive, collaborative, and purpose-driven work culture
Inclusion & Equal Opportunity
GSK is committed to fostering an inclusive workplace. Candidates who require adjustments during the recruitment process are encouraged to contact the recruitment team.
Important Notice
GSK does not charge any fees at any stage of the recruitment process and does not accept unsolicited agency referrals without prior written authorization. Candidates are advised to remain vigilant against fraudulent job advertisements.
Apply via thepharmadaily.com to explore global medical writing and clinical documentation career opportunities with GSK.
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