Senior Manager, Medical Writing

Company: LFB
Location: Framingham
Posted on: January 12, 2021

Job Description:

It's fun to work in a company where people truly BELIEVE in what they're doingWe're committed to bringing passion and customer focus to the business.The Senior Manager, Medical Writing will participate in ail aspects of clinical writing for assigned programs to ensure the timely completion of required documents at the highest standards (scientific,ethical, regulatory, and good clinical practice). Activities include:-- Assisting with establishment of document writing tools and development of document review procedures and standards-- Introducing and executing department initiatives related to resourcing, medical writing processes, and document standards-- Assisting in the development and maintenance of SOPs and writing tools, such as templates and style guides-- Providing training to other functional areas on medical writing templates, tools, SOPs, and standards-- Performing literature searches specific to products under development and contributing to the database of publications-- Identifying and managing external resources (writers, editors) and contributing to budgeting for such positions-- Authoring clinical study protocols and protocol amendments, clinical study reports, investigator brochures, clinical sections of lNDs/NDA/BLAJMAAs, and other documents such as the clinical sections of regulatory briefing packages-- Developing and maintaining timelines for document generation, revision, and completion-- Coordinating review cycles, resolving comments, and leading discussion for timely finalization of documents-- Planning for and scheduling Quality Control review of documents to ensure completeness and accuracy of data presentationIf you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with usJob InfoType: Full timeLocation: Framingham, MA

Keywords: LFB, Framingham , Senior Manager, Medical Writing, Executive , Framingham, Massachusetts