Senior Medical Writer – London

About the role

We’re seeking an organized, motivated, and collaborative individual to join our medical writing team in London. The Senior Medical Writer will partner with Clinical Development, Clinical Operations, Biostatistics, Regulatory and Program Management teams to plan and prepare high‑quality clinical regulatory documents.

Key responsibilities

• Lead execution of protocols, study reports, investigator brochures, narratives and module documents, managing timelines and project plans.
• Coordinate cross‑functional contributors and internal resources such as quality control and publishing to ensure timely delivery.
• Maintain compliance with client processes, templates and regulatory guidelines (ICH, US and ex‑US).
• Develop document messaging, interpret data, create shell documents and lead kickoff and comment‑resolution meetings.
• Conduct literature searches, perform peer QC reviews and contribute to operational initiatives such as templates and style guides.

Required profile

• 5+ years of medical writing experience in CRO, biotech or pharmaceutical environments.
• Bachelor’s degree or higher in a relevant scientific field.
• Experience writing clinical study reports, protocols, investigator brochures and module documents across therapeutic areas.
• Familiarity with lean authoring, structured content management and regulatory requirements (ICH, US, ex‑US).

Required skills

• Advanced proficiency with Microsoft Word and other Microsoft Office applications.
• Experience using document management systems, collaborative authoring tools and review platforms.
• Knowledge of structured content management and lean authoring approaches.