Sr Manager, Medical Writing

Job description

This role is considered Hybrid. Overview The Senior Manager, Medical Writing will collaborate with project teams on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs) and will oversee the work of contract writers on the clinical program. This hybrid position requires two days per week in our Maidenhead office. Key Responsibilities Produce high quality and on-time writing deliverables. Independently plan, write, edit, and format key documents, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documents. Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors. Represent Medical Writing on multiple early phase project teams or on specific late phase project teams and collaborate with the Director of Medical Writing to ensure proper planning and resourcing for upcoming project writing deliverables. Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders. Serve as subject matter expert for clinical documents and their production. Contribute to SOP and template development and maintenance Qualifications 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. 6+ years of experience as a medical writer in the sponsor and/or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus. 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. Impeccable attention to detail and ability to complete writing assignments in a timely manner. Experience overseeing the work of contract writers is a plus. Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint. Ability to travel approximately 10% is required. Demonstrate clear alignment with Alnylam Core Values About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality. Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we’ve been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.