Sr. Medical Writing Manager

Sr. Medical Writing Manager  Boston Area Our client an innovative medical technology company is seeking a Senior Medical Writer & Manager to manage medical writing for their Phase 1-4 clinical studies. This permanent position will write and prepare SOP templates, complex integrated clinical study reports, and other clinical and regulatory documents such as protocols, synopses, protocol amendments, informed consents, data monitoring, and imaging charters, annual reports, and investigators brochures etc. Other responsibilities include: §  Leading the process of critical review of clinical and regulatory documents and incorporating multiple reviews into successive drafts, reviewing tables, listings, case report forms, drafting safety narratives, being an active participant in clinical project team meetings and providing background information and editorial support for meeting abstracts, presentations, and manuscripts. §  Manage writing consultants and writing project outsourced to CROs and will be responsible for the oversight of quality for all such reports, and for the coordination of the timely delivery of writing projects across multiple clinical studies and programs. §  Drafting and/or review and updating of writing SOPS and be key departmental resource for regulatory and scientific writing guidances and processes. RequirementsR  MS or PhD in a scientific discipline R  5+ years biopharmaceutical industry experienceR  3+ years experience writing clinical regulatory documentsR  Working knowledge of ICH guidelines with a detailed understanding of writing guidances and regulationsR  Demonstrated experience in the creation, production and publishing of major regulatory filings such as NDAs and PMAs R  Demonstrated the ability to coordinate and prioritize multiple projects in a fast-paced environment. R  Some experience managing other writers or writing consultants is preferred. Background in cardiovascular imaging and diagnostics is a plus.  Interested? Email your résumé to david@mriweston.com or call Dave at 954-385-3122  MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: Boston, MA JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: Sr Medical Writer & Manager COMPANY: MRINetwork CONTACT NAME: David Schmitt PHONE: 954-385-3122 EMAIL: Apply by Email