Prepare and lead the medical writing team on Phase I-IV study documents such as protocols and protocol amendments, informed consent documents and assents, complete clinical trial reports (CTRs), CTR narratives, Investigator Brochures, and other study-related documents in accordance with regulatory requirements (USA, Europe and/or ROW) and WCT SOPs.
Prepare and lead the medical writing team on Phase I-IV study documents that are applicable in regions outside of the USA, including but not limited to IMPDs, Protocol Lay Summaries, CTR Lay Summaries, Assents etc.
Work with other departments in Worldwide preparing and leading the development of Pre-IND documents, synopsis, briefing books for all authorities (FDA, EMA, MHRA, Health Canada etc.) and updating all documents following agency feedback.
Responsible for key documents template management in accordance with global regulations.
Serve as publishing point-of-contact in conjunction with the Publisher for CTRs or other documents, as needed.

Excellent written and spoken English.
Ability to accurately interpret data and express findings in a clear and concise written manner.
Excellent project/time management and organizational skills, and ability to work independently.
Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
Comprehensive Microsoft Office skills, especially Word, but also PowerPoint, Excel, and Outlook.
Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9).
University/college degree (life science or related allied health profession) or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities to perform the above responsibilities.
Minimum of 4 years of experience as a Medical Writer or equivalent role as determined by management to have sufficient skills and knowledge.

Senior Medical Writer

Key skills