Manager, Global Labeling Product Leader
J&J Family of Companies
Manager, Global Labeling Product Leader
Salary Not Specified
J&J Family of Companies, Selby
- Full time
- Temporary
- Onsite working
Posted 2 days ago, 18 Sep | Get your application in today.
Closing date: Closing date not specified
job Ref: 31f9feb80df54547be3a36cf24f3379f
Full Job Description
- Lead the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU 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.
A minimum of Bachelor's degree (or equivalent) (required) - A degree in scientific discipline (required)
- An advanced degree (MS, PhD, MD or PharmD) (preferred), Minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance)
- An understanding of pharmaceutical drug development
- Experience in discussing and communicating scientific concepts
- Basic understanding of worldwide regulatory guidelines and their applications for guidance for labeling
- Experience leading project teams within a matrix environment, combined with the ability to work largely independently with limited supervision
- A demonstrated proactive approach, experience participating in continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation and partnering skills
- Experience working in document management systems
- 3 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent
- A successful track record of effectively/appropriately prioritizing and managing multiple products and projects simultaneously
- An understanding of pharmaceutical drug development
- Demonstrated ability to drive a collaborative, customer-focused, learning culture
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Global Labeling Product Leader in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Allschwil, Bern, Zug (Switzerland)
Preferred Skills:
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Our company thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.