Senior Manager, Medical Writing

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. 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