Senior Medical Writer – Cape Town

About the role

We are looking for an organized, motivated, and collaborative Senior Medical Writer to join our medical writing team in Cape Town. The role partners with client teams across Clinical Development, Operations, Biostatistics, Regulatory and Program Management to lead the planning and preparation of high‑quality clinical regulatory documents under tight timelines.

Key responsibilities

• Lead execution of clinical documents, managing timelines, coordinating cross‑functional contributors and internal resources such as quality control and publishing.
• Ensure document development follows client processes, templates and regulatory guidelines, and serve as an expert on the client’s document management system.
• 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 protocols, clinical study reports, investigator brochures, module 2 and module 5 documents.
• Ability to work across multiple therapeutic areas, with preferred experience in oncology, infectious disease or vaccines.

Required skills

• Advanced proficiency with Microsoft Word and the Microsoft Office suite.
• Experience using document management systems, collaborative authoring and review tools.
• Familiarity with lean authoring approaches and structured content management.
• Knowledge of ICH, US and ex‑US regulatory document requirements.