Manager, Global Labeling Operations

Company: Disability Solutions
Location: Raritan
Posted on: February 15, 2025

Job Description:

Johnson & Johnson is recruiting for a Manager, Global Labeling Operations to be located in Raritan, NJ, Titusville, NJ, or Horsham, PA.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.\rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.\rWe know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.\rAt Johnson & Johnson, we all belong.\rKey Responsibilities:Leads the implementation activities for labeling under the responsibility of Global Labeling Operations, including :

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• Provision of Regulatory guidance on the development of US packaging text for labeling mockups and production artwork.
• Requesting, reviewing, and approving mockups and production artwork in the designated electronic artwork management system.
• Management of labeling implementation inputs and deliverables for registration sample packs, Software as a Medical Device (SaMD), and other non-US labeling in scope of GL.
• Tracking implementation of artwork for safety changes and other types of labeling issued.
• Completing or providing input into Change Controls related to labeling implementation or delisting activities.
• Actively participates on project teams for launches, lifecycle changes, and Supply Chain-led labeling or packaging initiatives in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs, CMC Regulatory Affairs, Product Artwork, and others as needed.
• Provides timely and correct input and entries as needed in departmental labeling and project trackers. Updates labeling history documents related to product artwork changes.
• Obtains and prepares labeling implementation input for US Annual Reports.
• Assigns National Drug Code (NDC) numbers and maintains NDC log for J&J IM and Patriot Pharmaceutical US-marketed products. Supports Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) for US-marketed products.
• Supports the Legal Department with litigation efforts related to GL-managed labeling, as needed.
• Provides feedback on US Product Quality Complaints (PQC) related to product labeling and packaging artwork.
• Actively participates in or provides leadership of process improvement initiatives.
• Support audits and inspections as needed.\r\r

Keywords: Disability Solutions, New Brunswick , Manager, Global Labeling Operations, Executive , Raritan, New Jersey