Senior Medical Writer – Clinical and Regulatory Writing
Location: Bengaluru, India | Mississauga, Canada
Job Type: Full-Time / Hybrid Work Model
Experience Required: 3–5 years in clinical and regulatory medical writing
About GSK
At GSK, we unite science, technology, and talent to advance healthcare and improve the lives of billions worldwide. Our research and development focus on delivering vaccines and medicines that address the world’s most pressing health challenges. With a culture that fosters accountability, inclusivity, and innovation, GSK empowers employees to drive meaningful impact in patients’ lives across multiple therapeutic areas, including respiratory, oncology, immunology, HIV, and infectious diseases.
Role Overview
The Senior Medical Writer will independently manage complex clinical and regulatory writing assignments, ensuring high-quality scientific documentation that supports product development and regulatory submissions. This role requires expertise in clinical trial design, data interpretation, and regulatory requirements, combined with strong coordination and stakeholder management skills.
The Senior Medical Writer will collaborate across matrix organizations, including Clinical Leads, Biostatisticians, Study Delivery Leads, and other Medical Writers, to deliver high-quality documents such as protocols, clinical study reports, NDA/MAA submissions, investigator brochures, and regulatory responses.
Key Responsibilities
Document Creation & Review
Independently author and edit clinical and regulatory documents, ensuring accuracy, clarity, and compliance with global standards.
Draft protocols, clinical study reports (CSRs), briefing documents, investigator brochures, and regulatory submission documents (NDA/MAA CTD).
Ensure integrity and consistency of data interpretation across all documents.
Participate in peer reviews to maintain high medical writing standards.
Project Coordination & Stakeholder Engagement
Proactively coordinate with internal and external stakeholders to facilitate document development.
Manage 2–3 assignments simultaneously, tracking progress, timelines, and quality standards.
Identify and escalate risks or issues promptly, proposing effective solutions to maintain project timelines.
Build collaborative networks to streamline interactions across functional teams.
Compliance & Quality Assurance
Ensure adherence to Good Clinical Practice (GCP), regulatory requirements, and organizational quality standards.
Support review meetings and planning sessions to align writing assignments with project objectives.
Maintain documentation consistent with global regulatory expectations.
Required Qualifications
Experience: 3–5 years in clinical and regulatory medical writing within the pharmaceutical or biotechnology industry.
Education: Master’s degree or higher in Life Sciences, Pharmacy, Medicine, or related scientific discipline.
Proven expertise in drafting clinical regulatory documents, including CSRs, clinical summaries, and regulatory submissions.
Strong understanding of clinical trial design, statistical analysis, and interpretation of efficacy and safety data.
Excellent written and verbal communication skills in English.
Ability to work effectively in a complex matrix environment and manage multiple priorities.
Preferred Qualifications
In-depth knowledge of the drug development process.
Understanding of scientific methodology and statistical principles applied in clinical research.
Knowledge of ICH guidelines, GCP, and global regulatory standards.
Ability to independently analyze and interpret clinical data for scientific writing purposes.
Collaborative mindset with experience in cross-functional teams across global projects.
Working Model & Benefits
Hybrid Role: Core office days for collaboration and remote work flexibility for focused writing tasks.
Competitive base salary and annual bonus linked to company performance.
Learning and career development opportunities.
Access to healthcare, wellbeing programs, and employee recognition initiatives.
Why Join GSK
Contribute to life-changing medicines and vaccines with global impact.
Collaborate with international teams on advanced clinical research projects.
Gain exposure to cutting-edge scientific and digital tools accelerating drug development.
Thrive in an inclusive environment that values accountability, patient-centric innovation, and professional growth.
Apply now on ThePharmaDaily.com to become a Senior Medical Writer at GSK and help deliver high-quality scientific communication that drives global healthcare innovation.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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