Celldex

Responsibilities Will lead teams in the timely delivery of high quality clinical research documents across all phases of clinical drug development, including 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 and coordinates timely review, revision and approval of clinical documents. Involved in developing style guidelines, department SOPs, and document templates. Remains abreast of new regulatory guidance, industry trends, and technology and shares with the department and cross-functionally. Leads process improvements related to creation and maintenance of...