Role: Medical Writer specializing in oncology clinical and regulatory documentation
Contract length: Full time, permanent
Location: Fully remote
Rate: Competitive entry-level pay, details shared upon application
About the role
We’re looking for a Medical Writer to join a growing biotech team. You’ll author and help coordinate high-quality regulatory and clinical documents that support oncology drug development programs. This is a hands-on role where you’ll own documents from initial outline through final quality control, working closely with clinical, regulatory, and scientific teams.
This is an excellent opportunity to build deep expertise in oncology medical writing while contributing to real drug development work. You’ll gain exposure to the full regulatory lifecycle, from initial submissions through ongoing compliance documents.
What you’ll be doing
Regulatory & Clinical Document Authoring
You’ll write and coordinate a range of regulatory and clinical documents, including:
• Clinical protocols and protocol amendments
• Briefing documents for regulatory meetings
• Responses to health authority inquiries from regulatory agencies
• Informed consent forms
• Clinical study reports, protocol synopses, and study-related documents
• Annual safety reports and other periodic regulatory documents
• Investigator’s Brochures, including updates when new safety or efficacy data emerges
• Clinical development plans and study synopses
• Scientific and clinical publications
You’ll ensure all documents are scientifically accurate, clearly written, internally consistent, and aligned with current regulatory guidance. You’ll independently manage document timelines, working directly with clinical, regulatory, biostatistics, and other cross-functional teams to gather content, resolve data issues, and finalize documents to submission-ready quality.
Oncology & Scientific Expertise
You’ll apply working knowledge of oncology clinical development—including trial design, endpoints, and safety considerations—to ensure documents reflect appropriate scientific context. You’ll stay current on relevant regulatory guidance and oncology-specific requirements that may affect document content and strategy.
Process, Quality & Standards
You’ll ensure documents comply with formatting standards, applicable style guides, and internal templates. You’ll maintain consistency of terminology, data presentation, and referencing across related documents. As the team grows, you may help develop and refine templates and writing best practices. You’ll manage quality control and review cycles, incorporating feedback while maintaining document integrity and timelines.
Skills/background needed
Essential
• Bachelor’s degree in life sciences or related field
• 8+ years of regulatory or medical writing experience, with significant oncology drug development experience
• Hands-on experience authoring clinical and regulatory oncology submissions and amendments
• Experience supporting responses to health authority inquiries, including briefing documents for regulatory meetings
• Strong knowledge of ICH guidelines and regulatory document standards
• Excellent scientific writing skills with ability to synthesize complex clinical and nonclinical data into clear, accurate, well-organized documents
• Ability to work independently and manage multiple concurrent documents and timelines
• Strong cross-functional collaboration skills and comfort working directly with clinical, regulatory, and scientific leadership
Nice to have
• Advanced degree (PhD, PharmD, or MS)
• Experience with oncology-specific regulatory pathways (accelerated approval, breakthrough therapy designation)
• Familiarity with document management systems
• Prior experience in a small or growing biotech environment
Key competencies
• Exceptional scientific and technical writing skills with strong attention to accuracy, clarity, and regulatory compliance
• Self-directed and able to independently manage document development with appropriate subject matter expert input
• Strong project management skills; able to manage multiple documents and deadlines simultaneously
• Comfortable working under time pressure
• Effective communicator able to work with senior scientific, clinical, and regulatory stakeholders
• Detail-oriented with strong quality control discipline
What we offer
• Fully remote work—collaborate with your team from anywhere
• Opportunity to build specialized expertise in oncology medical writing
• Access to professional development and training to expand your regulatory knowledge
• Supportive, collaborative team environment
• Potential for growth as the organization scales
How to apply
Ready to take the next step? Submit your resume and a brief cover letter highlighting your oncology and regulatory writing experience. We review applications on a rolling basis and look forward to learning more about you.
Ready to get started? Submit your application below.