Manager Medical Writing

Manager, Medical Writing
We are seeking a Manager, Medical Writing to play a hands‑on role in the development of regulatory and clinical documentation for an oncology‑focused pipeline. This position will have significant responsibility for regulatory submissions, including Module 2 summaries, and will partner closely with Regulatory Affairs, Clinical Development, and Biometrics.

Base pay range
$150,000.00/yr – $170,000.00/yr

Key Responsibilities

Author, review, and coordinate regulatory and clinical documents with a strong emphasis on submission content

Lead development of

Module 2 documents , including clinical summaries and overviews, in collaboration with Regulatory Affairs and Clinical Development

Contribute to and support the preparation of IND, NDA, and BLA submissions

Author and review clinical study protocols, clinical study reports, investigator brochures, and related documents

Manage document planning, timelines, and review cycles across multiple programs or studies

Ensure content is scientifically accurate, consistent, and aligned with regulatory expectations and company standards

Partner cross-functionally with clinical, biometrics, pharmacovigilance, and regulatory teams to align on data interpretation and messaging

Support continuous improvement of templates, writing processes, and documentation standards

Qualifications

4+ years of medical writing experience in industry, a CRO, academia, or a combination

Demonstrated experience supporting

regulatory submissions , including Module 2 content

Oncology experience strongly preferred

Advanced degree preferred (PhD, PharmD, MD, or equivalent), but not required

Solid understanding of ICH guidelines and global regulatory documentation standards

Strong writing, editing, and organizational skills, with the ability to manage multiple deliverables concurrently

Location (hybrid on‑site model)

Bay Area, CA or Princeton, NJ

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