Manager, Global Labeling Operations

Role Overview

• Lead the implementation activities for labeling under the responsibility of Global Labeling (GL) Operations, including:
• Provision of Regulatory guidance on the development of U.S. packaging text for labeling mockups and production artwork.
• Request, review, and approve 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-U.S. labeling in scope of GL.
• Track implementation of artwork for safety changes and other types of labeling issued.
• Complete or provide input into Change Controls related to labeling implementation or delisting activities.
• Actively participate on project teams for launches, lifecycle changes, and Supply Chain-led labeling or packaging initiatives in partnership with Global Labeling Product Leaders, Supply Chain, Marketing, Regulatory Affairs, CMC Regulatory Affairs, Product Artwork, and others as needed.
• Provide timely and correct input and entries as needed in departmental labeling and project trackers.
• Update labeling history documents related to product artwork changes.
• Obtain and prepare labeling implementation input for U.S. Annual Reports.
• Assign National Drug Code (NDC) numbers and maintain NDC log for Johnson & Johnson Innovate Medicine and Patriot Pharmaceutical U.S.-marketed products.
• Support Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) for U.S.-marketed products.
• Support the Legal Department with litigation efforts related to GL-managed labeling, as needed.
• Provide feedback on U.S. Product Quality Complaints (PQC) related to product labeling and packaging artwork.
• Actively participate in or provide leadership of process improvement initiatives.
• Support audits and inspections, as needed.

Requirements

• A minimum of a Bachelor’s degree is required, preferably in a scientific discipline.
• A minimum of 4 years of relevant experience supporting labeling development, implementation, or operations is required.
• Experience in the Pharmaceutical industry is preferred.
• An understanding of pharmaceutical drug development is preferred.
• Knowledge of labeling processes and systems is required.
• Experience with NDA or BLA launches preferred.
• Understanding of audit and inspection processes and deliverables is preferred.
• Experience participating in continuous improvement projects is preferred.
• Experience in program/project management of quality and compliance activities associated with pharmaceutical labeling is preferred.
• Experience effectively/appropriately prioritizing and managing multiple projects simultaneously is preferred.
• Experience planning, scheduling, facilitating meetings across stakeholder groups is preferred.
• Experience working with dashboards and metrics (e.g., Tableau) preferred.
• Experience with Microsoft Office (Word, Excel, PowerPoint, Outlook), Teams tools and apps required.
• Must have excellent verbal and written communication skills.
• Must have strong organizational and negotiation skills.
• The ability to partner with cross-functional teams is required.
• The ability to drive a collaborative, customer-focused, learning culture is preferred.
• The ability to develop/deliver communications in a variety of settings for diverse audiences (e.g., announcements, newsletters, presentations) is preferred.

Tech Stack

• Tableau

Benefits

• Inclusive work environment
• Opportunities in Innovative Medicine
• Professional development opportunities