Job Details

The Principal Clinical Medical Writer has functional oversight responsibilities for medical writing staff and for the medical writing requirements for clinical development programs, including authoring/editing documents. RESPONSIBILITIES Oversight responsibilities for Medical Writing staff. Works with the Head of Medical Writing to establish and maintain timelines for program planning. Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports. Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigators brochures and periodic safety reports (e.g. PBRE - Rs, DSU - Rs)Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2/ Module 5 clinical or integrated summaries). Manages study team participation in the preparation of such documents, including ...Medical, Clinical, Writer, Principal, Project Management, Clinical Research, Healthcare