Principal Medical Writer
Location: Bengaluru, Karnataka, India
Category: Medical Writing | Clinical & Safety Writing
Job Type: Full-Time | Hybrid (Remote & On-Site)
Company Overview
Join GSK, a global biopharmaceutical leader, uniting science, technology, and talent to improve the lives of billions worldwide. With a mission to positively impact the health of 2.5 billion people by the end of the decade, GSK focuses on innovative vaccines and medicines across multiple therapeutic areas including respiratory, immunology, oncology, HIV, and infectious diseases. At GSK, you’ll be part of a diverse, inclusive culture where your work drives real impact on patients’ lives.
Benefits include:
Competitive base salary with annual performance bonus
Flexible working options
Learning and career development opportunities
Healthcare and wellbeing programs
Employee recognition programs
Position Summary
GSK is seeking an experienced Principal Medical Writer to lead the preparation of high-quality clinical, regulatory, and safety documents. This role requires strong expertise in complex medical writing, ability to work cross-functionally, and leadership skills to mentor junior writers. You will ensure content aligns with global regulatory requirements, integrates clinical and statistical data, and supports GSK’s mission to advance healthcare worldwide.
Key Responsibilities
Independently lead the preparation of complex medical and safety documents, including:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports / Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs)
US Periodic Adverse Drug Experience Reports (PADERs/PAERs)
Addendums to Clinical Overviews (ACOs)
Risk Management Plans (RMPs)
Responses to regulatory authority queries
Provide oversight and mentorship to co-authors or a team of medical writers.
Lead cross-functional teams in document planning, content strategy, review schedules, and project timelines.
Ensure accurate interpretation of clinical, safety, and statistical data in line with global, regional, and local regulatory standards.
Anticipate complex challenges and resolve issues using scientific and operational expertise.
Organize and summarize trends and patterns in data to effectively communicate safety messages.
Utilize advanced authoring tools, automation, and technology platforms to improve efficiency and document quality.
Contribute to vendor management and process improvement initiatives.
Develop and deliver training programs for junior writers and cross-functional teams.
Qualifications & Experience
Required:
Minimum 10 years of advanced medical and safety writing experience in the pharmaceutical industry.
Proven expertise in summarization and interpretation of complex clinical and safety data.
In-depth knowledge of regulatory guidelines (ICH, GVP, FDA, EMA) for clinical trials, pharmacovigilance, and document preparation.
Experience across multiple therapeutic areas to independently handle diverse projects.
Advanced understanding of statistical, medical, and regulatory concepts for high-quality medical writing.
Strong English language proficiency, both verbal and written.
Preferred:
Demonstrated ability to lead multiple projects and deliver high-quality documents on schedule.
Highly collaborative with experience in cross-functional and multicultural team settings.
Proficiency in automation tools, medical writing software, and technology platforms.
Experience mentoring junior writers and contributing to process improvements.
Work Model
This role is based in Bengaluru and offers a hybrid work model combining remote work with on-site collaboration.
Why GSK?
Contribute to global health initiatives impacting billions of lives.
Work in an inclusive, diverse environment with career growth opportunities.
Be part of innovative teams that advance science and patient care.
Apply now to take your medical writing career to the next level and make a meaningful impact on patient lives.
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China | Quarry Bay |Hubei :
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