Global Labeling Manager

hace 3 semanas


Sant Cugat del Vallès, España Boehringer Ingelheim España, S.A. A tiempo completo

As a Global Labeling Manager, you will work under the supervision of the Head of Global Labeling. Your primary responsibility will be to provide labeling-related advice to the Global Regulatory Strategy Lead (GRSL/GRL). You will support the creation and maintenance of the Company Core Data Sheet (CCDS) as the chair of the interdisciplinary Brand Labeling Team and a member of the Regulatory Excellence Team.

Tasks and responsibilities
  • Serve as a subject matter expert in labeling, supporting relevant functions on labeling regulations and language for Europe and other regions (e.g., US, Japan).
  • Collaborate closely with global teams to ensure the CCDS serves as a common basis for worldwide labeling documents.
  • Support the implementation of the CCDS into local Product Information globally.
  • Implement the CCDS into the EU Product Information for assigned products or medical devices.
Requirements:
  • Minimum of 2 years of relevant experience in the pharmaceutical industry.
  • Solid knowledge in pharmacology and/or medicine, with a preference for experience in pharmacovigilance and drug development.
  • Ability to translate scientific content into labeling language and use analytical skills to foster process development.
  • Experience in labeling and working in an international, cross-functional environment, preferably with exposure to project management.
  • Ability to work well under pressure, balance and prioritize diverse requirements, make independent decisions, and build strong interpersonal relationships.
  • Flexibility and willingness to adapt in a changing environment.
  • Proficiency in Microsoft Office.
  • Excellent oral and written communication and negotiation skills.
  • Strong meeting preparation and presentation skills. Very good English skills.
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