Global Labeling Manager

10 Jul, 2022

Jobs

Global Labeling Manager

Johnson & Johnson
Titusville, NJ; Spring House, PA;

Job Description

Janssen Research & Development, L.L.C., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Global Labeling Manager in Titusville, NJ, Raritan, NJ or Spring House, PA, Toronto, Ontario (CA), UK (High Wycombe), Netherlands (Leiden), Belgium (Beerse), or Switzerland (Allschwil, Bern, Zug).

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 and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Our company thrives on 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.

Key Responsibilities:

  1. Leads the implementation activities for labeling under the responsibility of the GL CoE. This includes:
  • Provision of deliverables for USPI and associated labeling, including SPL, as appropriate.
  • Requesting, reviewing, and approving US production artwork in the designated electronic artwork management system.
  • Tracking implementation of artwork for safety changes and other types of labeling issued.

2. Provides timely and correct input and entries as needed in departmental labeling and project trackers.

3. Actively participates on labeling project teams for the development of new or updated mock-ups and artwork in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs, CMC Regulatory Affairs, Product Artwork COE and others as needed.

4. Actively participates on New Product Launch Teams or Supply Chain-led labeling or packaging initiatives on behalf of the GL CoE to provide technical expertise with respect to packaging component text content as well as the requirements for layout and design.

5. Manages US labeling mock-ups for use in submission to Health Authority.

6. Engages in the development of packaging text for US labeling.

7. Updates labeling history documents related to product artwork changes.

8. Obtains and prepares labeling implementation input for US Annual Reports.

9. Assigns National Drug Code (NDC) numbers and maintains NDC log for Janssen and Patriot Pharmaceutical US-marketed products.

10. Supports Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) for US-marketed products.

11. Supports the Legal Department with litigation efforts related to GL CoE-managed labeling, as needed.

12. Provides feedback on US Product Quality Complaints (PQC) related to product labeling and packaging artwork.

13. Actively participates in or provides leadership of process improvement initiatives.

14. Support audits and inspections as needed.

Qualifications

Education:

  • University Degree (i.e., Bachelor’s degree) required

Experience And Skills:

Required:

  • 6 years relevant experience (including 2+ years health care industry)
  • Strong verbal and written communication, negotiation, and partnering skills
  • E2E labeling knowledge
  • Process Improvement knowledge
  • Track record of managing projects through to successful completion
  • Experience successfully working with and/or leading cross-functional teams
  • Experience working with external providers
  • Experience with labeling submission planning and implementation

Preferred:

  • Previous experience working within a regulatory labeling function developing packaging content and managing artwork implementation for pharmaceutical products
  • Experience working in artwork management systems
  • Experience leading project teams
  • A demonstrated proactive approach, experience leading continuous improvement projects, and exceptional verbal and written communication, negotiation, and partnering skills
  • Demonstrated ability to drive a collaborative, customer-focused, learning culture

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Learn more here

Job posted: 2022-07-10