Senior Medical Writer

Senior Freelance Medical Writer – Rare Disease | Gene Therapy

EU-Based, Remote.

We’re supporting a pioneering client at the forefront of gene therapy for rare diseases, and we’re looking for an experienced Senior Medical Writer (Freelance) to join as a consultant on critical regulatory writing projects.

Key Responsibilities:

• Support the BLA Submission
• Author and review key regulatory documents (EU & US), including: Clinical Study Reports (CSRs), Briefing Books, Clinical Protocols, Investigator’s Brochures
• Regulatory responses & submission documents for FDA information requests
• Translate complex clinical and scientific data into clear, concise, and regulatory-compliant content
• Support submission readiness and respond to Health Authority questions
• Contribute to continuous improvement initiatives in regulatory medical writing

Qualifications:

• MSc or PhD in Life Sciences, Medicine, or a related field
• 5+ years of medical writing experience in the pharma/biotech space, focused on regulatory documents e.g. MAA submissions
• Proven expertise in rare disease and gene therapy (required)
• In-depth understanding of the clinical development lifecycle and global regulatory frameworks (FDA/EMA, CTD)
• Strong communication and collaboration skills in a cross-functional, remote setting

If you have experience in rare diseases and gene therapy, we’d love to hear from you.