Associate Director / Director - Medical Writing, Oncology

This is a hands-on, individual-contributor role responsible for authoring and coordinating high-quality regulatory and clinical documents in support of the company's oncology development programs. This role partners closely with the SVP, Development and Regulatory Strategy and cross-functional teams (Clinical, Biostatistics, Nonclinical, CMC, Regulatory) to prepare, format, and QC, submission-ready clinical and regulatory documents across the product lifecycle. The ideal candidate is a strong, independent oncology medical writer who is comfortable owning documents end-to-end — from outline through final QC. The specific title and level will be determined based on the selected candidate's depth of oncology and regulatory writing experience.

Responsibilities

• Regulatory & Clinical Document Authoring
  • Author and/or lead the development of high-quality regulatory and clinical documents, including:
    • Core clinical documents including clinical protocols and amendments
    • Briefing documents for regulatory meetings (Pre-IND, End-of-Phase 2, Type C, etc.)
    • Responses to health authority inquiries (FDA and ex-US)
    • Informed consent forms (ICF)
    • Orphan drug designation and breakthrough therapy designation requests
    • Clinical Study Reports (CSRs), protocol synopses, and study-related documents
    • Annual reports (DSURs), and other periodic regulatory documents as needed
  • Authorship and maintain the Investigator's Brochure (IB), including annual updates and interim updates triggered by new safety or efficacy data.
  • Author or contribute to other clinical and scientific documents as needed, such as:
    • Clinical development plans and study synopses
    • Non-clinical modules in INDs and CTAs
    • Scientific and Clinical Publications
  • Ensure all documents are scientifically accurate, clearly written, internally consistent, and aligned with current regulatory guidance and company data.
  • Independently drive document timelines, working directly with Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Nonclinical, and CMC teams to gather content, resolve data discrepancies, and finalize documents to submission-ready quality.
  • Work closely with teams to gather and interpret source data for accurate document content.
  • Partner on document strategy, timelines, and prioritization across the program portfolio.
• Oncology & Scientific Expertise
  • Apply strong working knowledge of oncology clinical development (trial design, endpoints, safety considerations, and regulatory pathways specific to oncology) to ensure documents reflect appropriate scientific and clinical context.
  • Stay current on relevant regulatory guidance (FDA, ICH, EMA) and oncology-specific requirements (e.g., accelerated approval, breakthrough therapy, orphan drug designation) that may affect document content and strategy.
• Process, Quality & Standards
  • Ensure documents comply with CTD formatting and structure, applicable style guides, and internal templates.
  • Maintain consistency of terminology, data presentation, and referencing across related documents.
  • Support the development and refinement of templates, style guides, and medical writing best practices as the function matures.
  • Manage and perform (when appropriate) quality control (QC) and review cycles, incorporating cross-functional feedback while maintaining document integrity and timelines.
  • Coordinate with external medical writing vendors/consultants as needed for surge capacity, while retaining ownership of quality and strategy.

Requirements

• Bachelor's degree in life sciences required; advanced degree (PhD, PharmD, MS) strongly preferred.
• 8+ years of regulatory/medical writing experience, with a significant portion in oncology drug development.
• Direct, hands-on experience authoring clinical and regulatory oncology submissions and/or amendments.
• Experience supporting responses to health authority inquiries (FDA and/or ex-US agencies), including briefing documents for regulatory meetings.
• Strong knowledge of ICH guidelines (E3, E6, M4/CTD format) and regulatory document standards.
• Excellent scientific writing skills with the ability to synthesize complex clinical and nonclinical data into clear, accurate, well-organized documents.
• Demonstrated ability to work independently and manage multiple concurrent documents/timelines in a fast-paced environment.
• Strong cross-functional collaboration skills, with comfort working directly with clinical, regulatory, and scientific leadership.

Preferred Qualifications

• Experience with additional oncology-specific regulatory pathways (e.g., accelerated approval, breakthrough therapy designation, orphan drug designation).
• Familiarity with document management systems.
• Prior experience in a small or growing biotech, comfortable operating without a large, established medical writing infrastructure.

Skills

• Exceptional scientific and technical writing skills, with strong attention to accuracy, clarity, and regulatory compliance.
• Highly self-directed — able to independently manage document development with support from subject matter experts from concept through finalization.
• Strong project management skills; able to juggle multiple documents and deadlines simultaneously.
• Comfortable working under time pressure.
• Effective communicator able to work directly with senior scientific, clinical, and regulatory stakeholders.
• Detail-oriented with strong QC discipline across complex, data-dense documents.

Pay

The anticipated annual base salary range for candidates is $164,450 to $224,787. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors.