Associate Director, Global Labeling Lead

4 weeks ago

Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time
About the Role:

Takeda Pharmaceutical is seeking a highly skilled Associate Director, Global Labeling Lead to join our team. As a key member of our global labeling team, you will be responsible for developing and implementing labeling content and strategy for multiple assigned products in various stages of drug development.

Key Responsibilities:

  • Develop and implement labeling content and strategy for assigned products.
  • Manage labeling cross-functional teams and interface with senior management cross-functional teams.
  • Author and manage labeling documents, including TLP, CCDS, USPI, and EU SmPC.
  • Develop and execute labeling implementation plans to incorporate new scientific, safety, and clinical data.
  • Manage local exceptions and LOC interactions.
  • Escalate issues to global labeling management and propose risk mitigation strategies.
  • Develop and cultivate strong relationships among functions represented at the labeling cross-functional teams.
  • Conduct precedent searches and analyze relevant competitor labeling.

Requirements:

  • Bachelor's degree in a relevant field, preferably with an advanced scientific degree.
  • 8+ years of pharmaceutical industry experience, including 6 years of labeling experience or a combination of 5+ years regulatory and/or related experience.
  • Strong knowledge of US and EU product labeling requirements, regulations, and guidelines.
  • Knowledge of scientific principles and regulatory/quality systems relevant to drug development.
  • Ability to create, revise, and/or update product labeling for regulatory submissions.

Takeda Pharmaceutical is a patient-focused company that inspires and empowers employees to grow through life-changing work. We foster an inclusive, collaborative workplace and strive for excellence in everything we do. This position is currently classified as remote in accordance with Takeda's Hybrid and Remote Work policy.

U.S. Base Salary Range: $149,100.00 - $234,300.00

U.S. based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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