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Director, Global Labeling Lead
at Vertex Pharmaceuticals
Boston, MA

Director, Global Labeling Lead
at Vertex Pharmaceuticals
Boston, MA

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Description

Job Description:

The Global Labeling Team at Vertex is seeking an experienced and highly motivated Global Labeling Lead (GLL), who has a comprehensive understanding of strategic global labeling. They will have a proven ability to develop strong matrix working relationships, and will be responsible for collaborating across the global regulatory affairs department and with cross-functional experts to develop global labeling strategies for marketed and development products. A pro-active individual, the GLL will have a proven ability to lead, influence and work collaboratively.

Key Responsibilities:
  • Reporting into the Head of Global Labeling, the Global Labeling Lead will represent Global Labeling at product-specific global regulatory teams, labeling working groups and labeling governance committee meetings.
  • Lead the development of product labeling from early development (Target Labeling Profiles) through to life-cycle management
  • Manage complex labeling projects, including the development, review and approval of the Company Core Data Sheet (CCDS), European Summary of Product Characteristics and US Prescribing Information, as well as acting as a subject matter expert to provide strategic labeling advice for other regional labels.
  • The GLL will provide strong strategic guidance on Global labeling regulations, requirements, competitor labeling, and labeling trends.
  • Provide strategic and tactical labeling advice and guidance to teams.
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Qualification:

  • BSc. Advanced scientific related degree preferred; BA accepted based on experience. Advanced degree preferred
  • Demonstrated experience of leading the development and life-cycle management of global labeling, from Target Labeling Profiles to the Company Core Data Sheet.
  • Comprehensive knowledge of labeling regulations and guidance's governing drug development and maintenance in major markets (EU, US and Canada etc).
  • Clear and effective written and verbal communication skills, project management and presentation skills (articulate and persuasive). Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships.
  • Team player with the ability to establish and maintain strong relationships with all functional areas of the local and global organization.
  • Ability to lead and influence others and to collaborate effectively with peers, within global teams and in communicating with senior leadership.

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