About the position
Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager, Global Labeling Product Leader. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA. The Manager, Global Labeling Product Leader will be responsible for the following: 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.
Responsibilities
- Lead the development, revision, review, agreement, and maintenance of primary labeling 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.
- Ensure high quality and compliant labeling documents.
- Contribute to and participate in the global labeling strategy.
- Demonstrate an understanding of competitors in the therapeutic area and their development plans.
- Contribute 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.
- Advanced degree (Master’s, PhD, PharmD) in a scientific discipline is preferred.
- A minimum of 4 years of relevant experience in the pharmaceutical industry is required.
- A minimum of 3 years of Regulatory Affairs experience in product labeling/labeling regulations is preferred.
- 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.
- Exceptional verbal and written communication skills are required.
- Strong organizational, negotiation, and partnering skills are required.
- Ability to work independently is required.
Nice-to-haves
- 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.
Benefits
- Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Consolidated retirement plan (pension) and savings plan (401(k)).
- Vacation - up to 120 hours per calendar year.
- Sick time - up to 40 hours per calendar year.
- Holiday pay, including Floating Holidays - up to 13 days per calendar year.
- Work, Personal and Family Time - up to 40 hours per calendar year.
