Manager, Global Labeling Product Leader
About The Position
Global Labeling is a function within Global Regulatory Affairs responsible for strategically developing and managing product labeling throughout its lifecycle across therapeutic areas, established products, regions, and affiliates. Its end-to-end scope includes primary labeling documents—the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, and European Union Product Information (EUPI)—as well as derived labeling documents. The Manager, Global Labeling Product Leader leads labeling activities for assigned compounds, helping ensure labeling is high quality, compliant, scientifically sound, and delivered on time. The role provides guidance on labeling content, processes, and timelines; contributes to global labeling strategy and continuous improvement; and works with stakeholders to resolve issues affecting labeling or its supporting documentation.
Requirements
- Bachelor’s degree or higher in a scientific discipline.
- At least 4 years of relevant pharmaceutical-industry experience, such as Regulatory Affairs, Clinical, Medical Information, or Pharmacovigilance.
- Understanding of pharmaceutical drug development.
- Experience discussing and communicating scientific concepts.
- Basic understanding of worldwide regulatory guidelines and how they guide labeling.
- Experience leading project teams in a matrix environment and ability to work largely independently with limited supervision.
- Proactive approach and experience participating in continuous improvement projects.
- Exceptional verbal and written communication, organizational, negotiation, and partnering skills.
- Experience working in document management systems.
Nice To Haves
- Advanced degree (MS, PhD, MD, or PharmD).
- At least 3 years of Regulatory Affairs experience involving product labeling or labeling regulations, or equivalent.
- Successful track record of appropriately prioritizing and managing multiple products and projects simultaneously.
- Ability to drive a collaborative, customer-focused, learning culture.
Responsibilities
- Lead the development, revision, review, agreement, and maintenance of primary labeling documents (CCDS, USPI and associated patient labeling, and EUPI) and derived labeling documents for assigned compounds.
- Recommend and provide advice and guidance on labeling content, processes, timelines, and scientific integrity.
- Coordinate resolution of labeling issues that could affect primary or derived labeling or supporting documentation.
- Ensure labeling documents are high quality and compliant.
- Contribute to and participate in global labeling strategy, including understanding competitors, their therapeutic-area development plans and status, and labeling considerations for developing labeling and target labeling.
- Contribute to continuous improvement of the end-to-end labeling process.
Benefits
- Company consolidated retirement plan (pension) and 401(k) savings plan, subject to plan terms.
- Vacation: 120 hours per calendar year, subject to policy and date-of-hire terms.
- Sick time: 40 hours per calendar year, with different amounts for eligible Colorado and Washington residents.
- Holiday pay, including floating holidays: 13 days per calendar year.
- Work, Personal and Family Time: up to 40 hours per calendar year.
- Parental leave: 480 hours within one year of a child’s birth, adoption, or foster-care placement.
- Bereavement leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
- Caregiver leave: 80 hours in a 52-week rolling period.
- Volunteer leave: 32 hours per calendar year.
- Military spouse time off: 80 hours per calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
