Manager, Global Labeling Product Leader
About The Position
The Manager, Global Labeling Product Leader will be responsible for leading the development, revision, review, agreement, and maintenance of primary labeling documents, including the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents (labeling text for EU, US) for assigned compounds. This role involves making recommendations and providing advice and guidance on labeling content, processes, timelines, and scientific integrity. The position also requires coordinating the resolution of labeling issues, ensuring high-quality and compliant labeling documents, and contributing to the global labeling strategy. This includes understanding competitors in the therapeutic area, their development plans, and labeling aspects for target labeling. The role also focuses on contributing to the continuous improvement of the end-to-end labeling process.
Requirements
- A minimum of a Bachelor’s degree in a scientific discipline is required.
- A minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
- An understanding of pharmaceutical drug development is required.
- Experience in discussing and communicating scientific concepts is required.
- Basic understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required.
- Experience leading project teams in a matrix environment is required.
- Experience participating in continuous improvement projects is required.
- Experience working with document management systems is required.
- Must have exceptional verbal and written communication skills.
- Must have strong organizational, negotiation, and partnering skills.
- Must have the ability to work independently.
Nice To Haves
- Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.
- A minimum of 3 years of Regulatory Affairs experience in product labeling/labeling regulations, or equivalent is preferred.
- Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.
- The ability to drive a collaborative, customer-focused, learning culture is preferred.
Responsibilities
- Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents (labeling text for EU, US)) for assigned compounds.
- Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity.
- Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation.
- Ensure high quality and compliant labeling documents.
- Contribute to and participate in the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling.
- Contribute to the continuous improvement of the end-to-end labeling process.
Benefits
- Annual performance bonus
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (or 48/56 hours in CO/WA)
- 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 the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 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
