Celldex

Associate Director/Director, Medical Writing The Associate Director/Director, Medical Writing supports Celldex's clinical development programs through strategic and efficient management of medical writing projects, medical writing vendors, generation of documents relevant to clinical research, and meeting overall portfolio goals. Responsibilities Will lead teams in the timely delivery of high quality clinical research documents across all phases of clinical drug development. This includes but is not limited to: protocols, clinical study reports, Investigator's Brochures, and clinical summary modules. Uses strong knowledge of regulatory guidance to instruct the project team accordingly to prepare a high-quality, regulatory compliant document. Involved in MW process and tool development and training of colleagues Assumes a lead role in creation, execution and monitoring of complex documents, project plans, management of timelines, and coordination of review meetings. Plans...