Senior Medical Writer

Contract Details

• Duration: 9- 12 months
• Engagement: Freelance / Independent contractor
• Location: Fully remote, home based
• Start: Immediate or as agreed

About the Role

We are seeking an accomplished Lead Medical Writer with deep expertise in clinical development and protocol authorship to support a portfolio of clinical programs over a 12 month freelance engagement. This role is ideal for a highly skilled writer who thrives in a fast paced, science driven environment and can operate independently while collaborating closely with cross functional clinical teams.

As the Lead Medical Writer, you will take ownership of key clinical documents, ensuring scientific accuracy, regulatory alignment, and clarity of communication across all deliverables. You will play a central role in shaping clinical strategy through high quality writing and expert guidance.

Key Responsibilities

• Lead the development, writing, and revision of clinical protocols, protocol amendments, and associated study documents
• Prepare high quality clinical and regulatory documents, including Investigator's Brochures, clinical study reports (CSRs), and submission ready content
• Collaborate with clinical development, biostatistics, regulatory, and project management teams to ensure scientific consistency and alignment across documents
• Interpret complex clinical and scientific data to produce clear, concise, and accurate narratives
• Provide strategic input on document planning, timelines, and content development
• Ensure all documents meet regulatory requirements, internal standards, and industry best practices
• Manage multiple writing projects simultaneously while maintaining exceptional quality and attention to detail
• Serve as a subject matter expert for clinical development documentation, offering guidance to internal stakeholders as needed

Qualifications & Experience

• PhD or Master's degree in a life science discipline (e.g., biomedical sciences, pharmacology, clinical research)
• Extensive experience as a medical writer within the pharmaceutical, biotechnology, or clinical research sectors
• Proven track record in authoring clinical protocols and other core clinical development documents
• Strong understanding of clinical trial design, ICH GCP guidelines, and regulatory expectations
• Exceptional ability to interpret and communicate complex scientific information
• Highly organized, self directed, and able to manage multiple priorities in a remote setting
• Excellent written communication skills with meticulous attention to detail