Senior Freelance Medical Writer

Senior Freelance Medical Writer

EU – Remote

In this role, you will work as a consultant to support our biotech client in the dermatology space, focusing on regulatory medical writing for clinical development.

You will work remotely, collaborating with cross-functional teams, including Regulatory Affairs, Clinical, and Scientific teams, with full support from internal experts when needed.

Key Responsibilities:

• Author and review key regulatory documents for submissions within the EU and US, including: Clinical Study Reports (CSRs), Briefing Books, Clinical Protocols, Investigator’s Brochures, Regulatory responses and other submission documents as needed
• Collaborate with cross-functional teams to ensure alignment on document strategy
• Interpret and synthesise clinical and scientific data into clear, concise, and compelling documents
• Ensure compliance with global regulatory standards (ICH, FDA, EMA) throughout the writing process
• Support regulatory submissions by responding to Health Authority questions and preparing submission-ready documents
• Contribute to best practices and process improvements in regulatory medical writing

Qualifications:

• (PhD or MSc) in life sciences, medicine, or a related field.
• 5+ years in medical writing within the pharma/biotech industry, with a strong focus on regulatory documents
• Therapeutic Area Expertise: Experience in dermatology and immunology is a bonus
• Regulatory Knowledge: FDA/EMA submission requirements, and CTD structure
• Clinical Development Understanding: Familiarity with clinical trial design, protocol development, and regulatory processes from early to late-stage development