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
Ph D 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
