Job Description
The Manager, Global Labeling Operations will lead and oversee labeling implementation and lifecycle activities for Johnson & Johnson Innovative Medicine products. This hybrid role is based in Allschwil, Switzerland.
Responsibilities
Lead labeling implementation activities under Global Labeling Operations:
Provide regulatory guidance on U.S. packaging text for labeling mockups and production artwork.
Request, review, and approve mockups and production artwork in the electronic artwork management system.
Manage labeling implementation inputs and deliverables for registration sample packs, SaMD, and other non-U.S. labeling in scope of GL.
Track implementation of artwork for safety changes and other labeling issued.
Provide input into change controls related to labeling implementation or delisting activities.
Actively participate in project teams for launches, lifecycle changes, and supply‑chain‑led labeling initiatives, partnering with Global Labeling Product Leaders, Supply Chain, Marketing, Regulatory Affairs, CMC Regulatory Affairs, Product Artwork, and others.
Enter and maintain data in departmental labeling and project trackers, and 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 the NDC log for J&J Innovative Medicine and Patriot Pharmaceutical U.S.-marketed products; support Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL).
Support the Legal Department with litigation efforts related to GL‑managed labeling as needed.
Provide feedback on U.S. Product Quality Complaints related to product labeling and packaging artwork.
Lead or participate in process improvement initiatives.
Support audits and inspections as required.
Qualifications
Minimum bachelor’s degree, preferably in a scientific discipline.
At least 4 years of experience supporting labeling development, implementation, or operations.
Experience in the pharmaceutical industry preferred.
Understanding of pharmaceutical drug development preferred.
Knowledge of labeling processes and systems required.
Experience with NDA or BLA launches preferred.
Understanding of audit and inspection processes preferred.
Experience participating in continuous improvement projects preferred.
Experience in program or project management of quality and compliance activities associated with pharmaceutical labeling preferred.
Ability to prioritize and manage multiple projects simultaneously preferred.
Experience planning, scheduling, and facilitating meetings across stakeholder groups preferred.
Experience with dashboards and metrics (e.g., Tableau) preferred.
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) and Teams required.
Excellent verbal and written communication skills required.
Strong organizational and negotiation skills required.
Ability to partner with cross‑functional teams required.
Customer‑focused, collaborative learning culture preferred.
Ability to develop and deliver communications for diverse audiences preferred.
Preferred Skills
Coaching
Compliance Management
Continuous Improvement
Design Thinking
Package and Labeling Regulations
Process Improvements
Product Packaging Design
Quality Assurance (QA)
Regulatory Affairs Management
Regulatory Compliance
Standard Operating Procedure (SOP)
Strategic Thinking
Sustainability
Sustainable Packaging
Technical Credibility
Transparency Reporting
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