Associate Director / Director - Medical Writing, Oncology

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. We are seeking someone with 8+ years of regulatory/medical writing experience, with substantial oncology medical writing experience. The candidate should be able to execute documents independently with appropriate input from subject matter experts and should feel comfortable developing and refining templates, style guides, and medical writing best practices as the function matures. As needed, the candidate should also be comfortable coordinating with external consultants and vendors.

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 to gather and interpret source data for accurate document content.

• Partner 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