Associate Director, Medical Writing - Lead Clinical Docs

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 the creation and review of clinical and regulatory documents, including INDs, CTAs, CSRs, and IBs, ensuring compliance with SOPs, GCP, and ICH guidelines.

You will coordinate external vendors, collaborate with Regulatory Affairs, and guide junior writers while contributing to document strategy and timelines within a fast-paced, small-company environment in the U.S. market.

Qualifications

• Bachelor’s degree in a scientific, healthcare, or related discipline; advanced degree preferred.
• 8–12 years of medical writing experience in pharma/biotech/CRO; authoring protocols/CSRs/IBs and INDs/CTAs.
• Experience in oncology therapeutic areas strongly preferred.
• Ability to interpret and present clinical data clearly for regulatory audiences.
• Strong organizational and project management skills with ability to manage multiple projects.

Responsibilities

• Lead medical writer for assigned studies and programs, planning, writing, editing, and finalizing regulatory documents.
• Coordinate and oversee external medical writing vendors to meet scope, timelines, and quality.
• Partner with Regulatory Affairs and cross-functional SMEs for regulatory submissions.
• Represent Medical Writing on project teams, advising on content and formatting requirements.
• Provide mentorship to junior writers and contractors within projects.

Skills

Medical Writing

Project Management

Regulatory Documentation

Cross-functional Collaboration

Vendor Management

Education

Bachelor's in Science

Advanced degree (MS/PhD)

Tools

MS Word

Adobe Acrobat

Job description

BlossomHill Therapeutics, Inc. is seeking an Associate Director, Medical Writing to lead the creation and review of clinical and regulatory documents, including INDs, CTAs, CSRs, and IBs, ensuring compliance with SOPs, GCP, and ICH guidelines.

You will coordinate external vendors, collaborate with Regulatory Affairs, and guide junior writers while contributing to document strategy and timelines within a fast-paced, small-company environment in the U.S. market.