GSK
Principal Medical Writer
Durham Blackwell Street +1 · On-site · Principal · Full-time · Posted Aug 5, 2026
- Location
- Durham Blackwell Street
UK – London – New Oxford Street - Experience
- 5+ years in medical or regulatory writing; 3+ years in regulatory dossier development and CTD module documents; 3+ years independently authoring clinical protocols, clinical study reports, and regulatory submission documents.
- Education
- Bachelor’s degree in life sciences, health sciences, or a scientific field.
About the job
Leads medical writing and strategic planning for clinical and regulatory documents, coordinating cross-functional teams and translating clinical data into clear scientific narratives.
What you'll do
- Author and plan clinical and regulatory documents, including protocols, clinical study reports, briefing documents, and submission dossiers.
- Manage writing projects, contributors, timelines, quality checks, and compliance activities.
- Advise on medical writing standards and regulatory expectations; support process improvement, KPI tracking, and audit readiness.
What they ask for
- Bachelor’s degree in life sciences, health sciences, or a scientific field.
- 5+ years of medical or regulatory writing experience in the pharmaceutical or healthcare industry.
- 3+ years of experience with regulatory dossier development and Common Technical Document (CTD) module documents.
- 3+ years of independent authorship of clinical protocols, clinical study reports, and regulatory submission documents.
Nice to have
- Advanced degree (e.g., PhD, PharmD, MPH, MS) in life sciences or a related field.
- Experience leading regulatory submission projects, including Common Technical Document (CTD) dossiers.
Tools
Common Technical Document (CTD), International Council for Harmonization (ICH) guidelines, Good Clinical Practice (GCP)
Model-written summary · the original posting is authoritative