Sr. Director, Head of Medical Writing and Labeling
Company: Biogen Idec
Location: Somerville
Posted on: January 12, 2021
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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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