Principal Medical Writer

This role demands a deep understanding of clinical trial designs, statistical analysis interpretation, and clinical document processes.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

For candidates seeking to be located at our Stevenage site, this role will temporarily be based ever, the Company plans to relocate its offices to Cambridge, UK . The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029 .

• Author and deliver high‑quality clinical regulatory documents, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures, briefing documents, CTD submission documents, and responses to regulatory authority questions.
• Lead and contribute to the planning, development, and delivery of clinical dossier documents for global regulatory submissions, ensuring quality, consistency, and timeliness.
• Partner within cross‑functional, matrix teams to produce fit‑for‑purpose documents that accurately reflect clinical and statistical data and comply with GSK standards and regulatory requirements.
• Manage complex writing projects, coordinating multiple contributors and adapting plans to address evolving priorities, therapeutic areas, and submission needs.
• Interpret complex clinical and statistical information, identify key trends and messages, and translate data into clear, well‑structured regulatory narratives.
• Review reporting and analysis plans, provide critical input on tables and data presentation, and apply efficient document development approaches, including review tools and automation.

• PhD or equivalent relevant experience within the life sciences.
• Advanced experience in clinical regulatory medical writing within the pharmaceutical industry.
• Demonstrated ability to independently author complex regulatory documents and lead or significantly contribute to CTD submission dossiers, including Module 2 documents.
• Strong understanding of clinical trial design, regulatory requirements, statistical concepts, and interpretation of clinical data.
• Proven leadership capability with experience influencing and collaborating effectively in global, multicultural, and matrixed environments.
• Working knowledge of ICH guidelines, Good Clinical Practice (GCP), and strong written and verbal English communication skills.

Closing Date for Applications – 17/08/

Please take a copy of the Job Description, as this will not be available post closure of the advert.

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Our approach to R&D .

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Clinical Development, Clinical Trial Designs, Communication, Customer Service, Decision Making, Emotional Intelligence, Influencing Without Authority, Learning Agility, Literature Reviews, Medical Writing, Pharmaceutical Industry, Presentation Techniques, Regulatory Submissions, Scientific Writing, Strategic Thinking

In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD
118,000 to CAD
168,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.

Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant…