Principal Medical Writer

Produce high-quality and on-time clinical documents Independently plan, coordinate, develop, update, and revise key documents, including clinical protocols, investigator brochures, clinical study reports, integrated efficacy and safety summaries, and related documents. Independently lead supplemental filings, Type 2 Variations, rest-of-world filings, and clinical responses to questions Provide medical writing subject matter expertise and leadership to project teams and collaborate with the Medical Writing line management to ensure proper planning and resourcing for upcoming project team writing deliverables. Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors. Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, Medical Affairs, as well as with external stakeholders. Contribute to the development and standardization of templates and related processes to support the medical writing needs of a growing organization and assist in training staff and contractors on MW processes. Provide medical writing subject matter expertise and oversight for post-approval regulatory documents, such as PASS and other non-interventional protocols. Assist the line managers in the training and development of junior staff. Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred. 7+ years of experience as a medical writer in the sponsor/CRO setting. Experience with regulatory submissions (NDA/BLA/MAA) strongly preferred. CTA/IND experience is a plus. Some experience with developing MW processes and standards preferred In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process. Successful track record of managing multiple projects in a fast-paced and deadline-driven environment. Knowledge of eCTD formatting and EDMS systems preferred. Experience overseeing the work of contract writers. Impeccable attention to detail. Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint.