Senior Medical Writer – Regulatory & Clinical Development
Location: Bengaluru, India | Mississauga, Canada
Employment Type: Full-Time | Hybrid
Experience Required: 3–5 Years (Clinical & Regulatory Medical Writing)
Application Deadline: February 6, 2026
About GSK
GSK is a global biopharmaceutical company driven by a bold ambition—to positively impact the health of 2.5 billion people by the end of this decade. By uniting science, technology, and talent, GSK accelerates the discovery and delivery of innovative vaccines and medicines across key therapeutic areas including oncology, immunology, respiratory diseases, HIV, and infectious diseases.
GSK’s culture is anchored in being ambitious for patients, accountable for impact, and committed to doing the right thing, ensuring high-quality outcomes that truly matter to patients worldwide.
Role Overview
The Senior Medical Writer will independently author and manage complex clinical and regulatory documents while collaborating across global, matrixed teams. This role requires a strong understanding of clinical trial design, statistical data interpretation, and regulatory submission standards.
You will take ownership of end-to-end document development—from planning and drafting through review and final approval—ensuring accuracy, consistency, and compliance with global regulatory standards.
Key Responsibilities
Medical & Regulatory Writing
Author and manage a wide range of clinical and regulatory documents, including:
Clinical Study Protocols
Clinical Study Reports (CSRs)
Investigator’s Brochures
NDA/MAA CTD submission documents
Regulatory briefing documents and responses to health authority queries
Ensure high-quality scientific interpretation of safety and efficacy data.
Maintain consistency, accuracy, and regulatory compliance across all deliverables.
Project & Stakeholder Coordination
Lead document development processes by coordinating with clinical leads, biostatisticians, study delivery teams, and other medical writers.
Participate actively in planning, review, and cross-functional meetings.
Manage multiple writing assignments simultaneously while meeting timelines.
Quality & Continuous Improvement
Proactively identify content gaps, data inconsistencies, or process risks and propose solutions.
Uphold and promote global medical writing standards across teams.
Support collaboration within complex matrix organizations to ensure smooth document delivery.
Required Qualifications & Experience
Education: Master’s degree or higher in Life Sciences, Pharmacy, Medicine, or a related scientific discipline.
Experience:
3–5 years of hands-on experience in clinical and regulatory medical writing within the pharmaceutical industry.
Technical Expertise:
Proven experience authoring CSRs, clinical summaries, and regulatory submission documents.
Strong understanding of clinical trial design, safety and efficacy data analysis, and interpretation.
Skills:
Excellent written and verbal English communication skills.
Ability to work independently in a fast-paced, matrix environment.
Strong organizational and stakeholder management capabilities.
Preferred Qualifications
Knowledge of the drug development lifecycle.
Understanding of scientific methodology and statistical principles in clinical research.
Familiarity with ICH guidelines and Good Clinical Practice (GCP).
Ability to interpret, document, and clearly communicate complex clinical data.
Work Model
This is a hybrid role, based in India, combining in-office collaboration with flexible remote working for focused writing activities.
Why Join GSK?
At GSK, your work directly contributes to advancing global health. You will collaborate with world-class scientists, clinicians, and data experts in an environment that values integrity, inclusion, innovation, and impact.
GSK offers a workplace where professionals can grow, thrive, and make a meaningful difference—while working on therapies that change lives at scale.
Equal Opportunity & Inclusion
GSK is an equal opportunity employer and is committed to fostering an inclusive workplace. Reasonable accommodations are available throughout the recruitment process for qualified candidates.
Apply Now
Interested candidates can explore this opportunity and apply through GSK’s official careers platform.
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