Lead Medical Writing - Oncology Programs

BlossomHill Therapeutics, Inc.; San Diego (CA); On-site; USD 195,000 - 223,000; Full time

Job summary

BlossomHill Therapeutics, Inc. is seeking an Associate Director, Medical Writing to lead writing efforts for clinical and regulatory documents. Reporting to the Senior Director, Medical Writing, you will collaborate with cross-functional teams to ensure accuracy, regulatory compliance, and timely delivery.

Responsibilities include coordinating timelines, managing vendors, and guiding junior writers. A strong background in oncology writing and a track record of high-quality submissions is

Qualifications

• 8–12 years of medical writing experience in pharma/biotech or CRO.
• Experience drafting clinical/regulatory documents such as protocols, CSRs, IBs, and IND/CTA components.
• Oncology experience strongly preferred.
• Strong organizational and project management skills with ability to lead multiple timelines.
• Ability to write clearly for regulatory and clinical audiences.

Responsibilities

• Lead medical writing for assigned studies and programs, planning, authoring, editing, and finalizing non-clinical, clinical, and regulatory documents (INDs, CTAs, CSRs, IBs, etc).
• Coordinate storytelling, review cycles, and final formatting to meet regulatory and internal standards.
• Oversee external medical writing vendors to ensure timely, high-quality deliverables.
• Partner with Regulatory Affairs and cross-functional experts on document strategy for submissions.
• Provide mentorship to junior writers and contribute to templates and SOPs.

Skills

Medical writing

Regulatory submissions

Project management

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree in science/healthcare

Master’s or PhD preferred

Tools

Microsoft Word

Excel

Document management systems

Job description

BlossomHill Therapeutics, Inc. is seeking an Associate Director, Medical Writing to lead writing efforts for clinical and regulatory documents. Reporting to the Senior Director, Medical Writing, you will collaborate with cross-functional teams to ensure accuracy, regulatory compliance, and timely delivery.

Responsibilities include coordinating timelines, managing vendors, and guiding junior writers. A strong background in oncology writing and a track record of high-quality submissions is