Associate Director, Global Labeling Lead

Takeda

Massachusetts, US
Base: $154,400.00 - $242,550.00; bonus/equity: not...
Hybrid
Global labeling strategy development
Labeling cross-functional team management
Us and eu product labeling requirements
Takeda is seeking an Associate Director, Global Labeling Lead, to oversee the development and implementation of labeling strategies for multiple pharmaceutical products. The role requires strong project management skills and extensive experience in pharmaceutical labeling, with a focus on compliance with regulatory requirements

Job Summary

  • Responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development.
  • Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content.
  • Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.

Matching Summary

Match Score: 85

Takeda is seeking an Associate Director, Global Labeling Lead, to oversee the development and implementation of labeling strategies for multiple pharmaceutical products. The role requires strong project management skills and extensive experience in pharmaceutical labeling, with a focus on compliance with regulatory requirements.

Salary

Base: $154,400.00 - $242,550.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement, PTO

Skills & Requirements

Must-have

  • Global labeling strategy development
  • Labeling cross-functional team management
  • US and EU product labeling requirements
  • Authoring TLP, CCDS, USPI, EU SmPC
  • Health Authority negotiations

Nice-to-have

  • Forward-looking R&D organization
  • Transformative therapies to patients
  • Patient-focused company
  • Inclusive, collaborative workplace

Key Requirements

  • 8+ years pharmaceutical industry experience
  • 6 years labeling experience
  • BSc degree or BA accepted
  • Advanced scientific degree preferred
  • Strong knowledge of US and EU labeling regulations
  • Ability to create/revise product labeling with minimal supervision

Work Rights

Not specified

Tailored Resume

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