Expert Medical Writer

About the role

The Expert Medical Writer will lead the planning, authoring, and coordination of high‑impact clinical and regulatory documents supporting global marketing applications. This senior position combines hands‑on writing with programme‑level leadership and mentorship of a writing team.

Key responsibilities

• Lead and oversee medical‑writing deliverables for full CTD submissions across multiple development programs, ensuring scientific integrity and on‑time delivery.
• Act as subject‑matter expert on regulatory requirements, guiding data‑pooling, analysis plans, and document positioning.
• Write and critically review CSRs, CTD Module 2 documents, agency responses, briefing packages, safety updates, PIPs, investigator brochures, and related materials.
• Collaborate with Clinical, Biostatistics, Clinical Pharmacology, Drug Safety, CMC, Regulatory Affairs and other stakeholders to align data presentation.
• Supervise senior/regulatory writers and disclosure managers, providing coaching and performance feedback.
• Manage outsourced writing vendors, ensuring quality and budget compliance.
• Drive process and technology improvements, focusing on AI‑enabled authoring tools and template enhancements.

Required profile

• BSc in Life Sciences or equivalent.
• Over 7 years of medical‑writing experience in pharma/biotech with multiple successful global submissions.
• Proven leadership of junior‑level writers and experience mentoring writers.
• Advanced knowledge of global regulatory guidelines.
• Excellent written and spoken English.
• Ability to set priorities, manage risk, and meet aggressive timelines.

Required skills

• Interpretation and clear presentation of complex scientific data.
• Strategic contribution to regulatory documentation planning.

What we offer

• Friendly working atmosphere in a great team, Great Place to Work® certified.
• Development opportunities within an international company.
• Benefits such as pension scheme and lunch allowance.