Roles & Responsibilities:
• Independently author and review complex clinical and regulatory documents, including protocols, clinical study reports (CSRs), NDA/MAA CTD submission documents, investigator brochures, briefing documents, and regulatory responses.
• Ensure high integrity and consistency of data interpretation in all written assignments.
• Participate in planning, coordination, and review meetings for document preparation.
• Manage 2–3 assignments simultaneously, proactively raising concerns and proposing solutions.
• Collaborate with diverse roles within GSK, including Clinical Leads, Asset Leads, Study Delivery Leads, Biostatisticians, and other Medical Writers.
• Build and maintain effective communication networks to facilitate smooth cross-functional collaboration.
• Adhere to GCP, ICH guidelines, and organizational quality standards for medical writing.
Qualification:
• Master’s degree or higher in Life Sciences, Pharmacy, Medicine, or a related scientific discipline.
Experience:
• Up to 5 years of experience in clinical and regulatory writing in the pharmaceutical industry.
• Demonstrated experience preparing clinical regulatory documents, including CSRs, clinical summaries, and overviews.
• Understanding of clinical trial design, statistical analysis, and interpretation of safety and efficacy results.
Skills:
• Strong written and verbal English communication skills.
• Ability to work in a complex matrix environment and manage multiple priorities.
• Knowledge of basic drug development, scientific methodology, and statistical principles.
• Familiarity with ICH/GCP guidelines and regulatory submission processes.
About the Organisation:
GSK is a global biopharmaceutical company focused on discovering and delivering vaccines and medicines to improve the health of 2.5 billion people by the end of the decade. GSK fosters a collaborative, patient-centric culture, combining science, technology, and talent to drive innovation and high-quality outcomes while supporting employee development and inclusivity.
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