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Sr. Director, Head of Medical Writing and Labeling

Company: Biogen Idec
Location: Somerville
Posted on: January 12, 2021

Job Description:

Job DescriptionThe Senior Director of Medical Writing and Labeling provides leadership and oversight for the medical writing and labeling functions including strategic direction for the functions and building the functions to meet and anticipate Biogen---s business needs. Provides strategic direction and guidance on medical writing documents and labeling to meet regulations and the global needs of Biogen. Partners with R&D departments to ensure milestones are met for development and marketed products throughout their lifecycle.Functions as a strong people manager and technical leader, with demonstrated management, scientific, and customer-focused leadership skills. Provides mentoring and career development to direct reports to create a high-quality and productive group. Needs to have knowledge of requirements related to clinical regulatory documentation, Target Label Profiles, and Core Data Sheets to support all phases of clinical development (Phase 1-4). Liaises within pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and trends; and influences the industry environment regarding medical writing and labeling.Qualifications-- 15 years in Life Science industry with experience in Medical Writing, Safety, Regulatory, or Labeling-- 10 years people management of global and matrixed teams-- Experience leading a functional group-- Strong communication skillsAdditional InformationAll your information will be kept confidential according to EEO guidelines.SummaryType: Full-timeFunction: Quality Assurance

Keywords: Biogen Idec, Somerville , Sr. Director, Head of Medical Writing and Labeling, Executive , Somerville, Massachusetts

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