Celldex Therapeutics, Inc.

Overview The Associate Director, Medical Writer at Celldex will lead the development and management of complex clinical and regulatory documents, including protocols, investigator brochures, study reports, and regulatory submissions for our immunology programs. This role requires extensive medical writing expertise, cross-functional project leadership, and the ability to drive timelines and ensure compliance with regulatory standards in a fast-paced clinical development environment. Responsibilities Responsible for the generation of clinical regulatory documents including, but not limited to: briefing documents, IND annual reports, Investigator's Brochures, clinical protocols and amendments, clinical study reports, scientific manuscripts and abstracts. Assume a lead role in creation, execution and monitoring of complex documents, project plans, management of timelines, and coordination of review meetings. Plan and coordinate timely review, revision and approval of clinical...