Sr Manager, Medical Writing

Produce high-quality, on-time medical writing deliverables across the clinical development lifecycle. Independently plan, write, edit, and format key documents including clinical protocols, investigator brochures, clinical study reports, and integrated summaries of safety and efficacy. Represent Medical Writing on CNS project teams, collaborating across functions to support program goals and timelines. Facilitate efficient document review and finalization processes for materials developed internally and/or by external vendors and contract writers. Oversee and provide direction to contract medical writers, ensuring consistency, quality, and adherence to standards. Engage confidently with a broad range of stakeholders, demonstrating strong stakeholder management, clear communication, and the ability to manage expectations with a sense of urgency. Prepare effectively for cross-functional meetings and maintain a strong \u201cbig-picture\u201d mindset while delivering at pace. Contribute to the development and maintenance of medical writing SOPs and templates. Bachelor\u0027s degree in Life Sciences with relevant writing expertise, or in English/Communications with strong scientific experience; advanced degree or professional certification preferred. 6+ years of experience as a medical writer within a pharmaceutical organisation preferably. In-depth knowledge of GCP, FDA regulations, ICH guidelines, and the drug development process. Demonstrated ability to manage multiple priorities in a fast-paced, deadline-driven environment. Proven ability to work collaboratively, communicate openly, and adapt writing style for different audiences. Flexibility to work across global time zones, with the majority of stakeholders based in U.S. Eastern Time (EST). High attention to detail and strong proficiency with Microsoft Word, Excel, and PowerPoint.