Director, Regulatory Medical Writing Consultant

Director, Regulatory Medical Writing

Remote | Oncology | NDA Submissions | FDA-Facing Leadership


A growing oncology-focused biopharmaceutical organization is seeking an experienced Director of Regulatory Medical Writing to support late-stage regulatory submission activities for its endometrial cancer program. This is a highly visible, strategic role with the opportunity to evolve into a submission lead position for a critical oncology asset.


The ideal candidate will possess a strong blend of deep clinical foundational knowledge, advanced regulatory writing expertise, and meaningful experience interacting directly with the FDA. This individual will initially partner closely with Regulatory Affairs leadership and will have the opportunity to become the lead writer on the program once they demonstrate strong clinical understanding and effectiveness in regulatory and FDA-facing activities.

Key Responsibilities

• Lead t...