Senior Medical Writing Leader (Contract Contract Opportunity)

Remote | 12-Month Contract 

A growing biotechnology organization focused on advancing innovative cancer therapies is seeking an experienced Senior Medical Writing Leader to provide strategic and operational leadership across clinical development programs. This individual will play a key role in guiding the preparation and delivery of high-quality regulatory and clinical documents that support global development and registration activities.

Key Responsibilities

• Provide leadership for the development of clinical and regulatory documentation, including protocols, investigator brochures, clinical study reports, regulatory submissions, and health authority briefing materials.
• Translate complex scientific and clinical data into clear, accurate, and submission-ready documents.
• Partner with cross-functional teams including Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations.
• Drive document strategy, timelines, review cycles, and approval processes across multiple programs.
• Lead and mentor medical writing personnel and/or oversee external writing vendors.
• Ensure compliance with applicable regulatory guidelines and industry standards.
• Support organizational efforts to optimize document development processes and leverage emerging technologies.

Requirements

• Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent).
• 10+ years of medical writing experience within the biotechnology or pharmaceutical industry, including management responsibility of a medical writing team.
• Demonstrated success supporting major regulatory submissions (NDA/BLA) for oncology
• Experience managing complex projects and influencing cross-functional stakeholders.
• Exceptional written, verbal, organizational, and leadership skills.
• Experience working in fast-paced, growth-oriented environments.
• Familiarity with innovative technologies and AI-enabled solutions for document development is preferred.

Ideal Candidate

The successful candidate will combine scientific expertise, strategic thinking, and leadership skills with a passion for delivering high-quality regulatory and clinical documentation. If you are interested in a senior-level contract opportunity with a dynamic life sciences organization, we encourage you to apply.