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OPERATIONS MANAGER – INDIVIDUAL CONTRIBUTOR
Type of Role: The Manager, Individual Contributor leads labeling submission planning and implementation activities on behalf of Client R&D Global Labeling Centre of Excellence (GL CoE).
Impact (Outcomes) of Decision-Making: The Manager, Individual Contributor makes decisions that have an impact on the planning and implementation of labeling documents. This position makes recommendations that can have an impact on process improvements for standards, processes, technologies, and resourcing.
Accountability/Decision-Making: The Manager, Individual Contributor, makes recommendations and decisions to identify and understand complex problems and recommends, effective, compliant solutions within a global organization. This position works independently and as a member of a team when making recommendations and decisions.
• Proficient in MS Office Suite and Adobe Acrobat.
• Knowledge of regulatory and supply chain as it relates to labeling development and implementation.
• Knowledge with the business systems and tools relevant to the job, including electronic labeling or artwork management systems.
• Knowledge with US and EU labeling submission types guidance and regulations.
• Knowledge of Company Core Data Sheets and their relationship to local labeling is required.
Supervision Received: The Manager, Individual Contributor reports to the Associate Director or Director. This position works as a member or leader of a team with minimal oversight depending on the project.
Supervision Given: The Manager, Individual Contributor mentors/trains others, as needed.
Operations Specific Competencies: Primarily at the Applying Level.
LSM Common Competencies: Primarily at the Applying Level.
Regulatory Affairs Competencies: Primarily at the Applying Level.
1. Leads the planning and implementation activities for primary labeling (i.e., CCDS, USPI, EUPI) and derived labeling for labeling projects under the responsibility of the GL CoE. This includes planning for:
• Development and/or distribution of CCDS via Core Labeling Change Notifications, including early and clear communication with impacted global stakeholders.
• Provides deliverables for USPI and associated labeling, including SPL, as appropriate.
• Provides relevant documents for submissions for EUPI products, including provision of labeling input for EU response documents.
2. Creates and manages labeling project tracking entries as needed in departmental labeling trackers.
3. Leads Packaging Development teams for the development of new or updated mock-ups and artwork in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, US/EU Regulatory Affairs, CMC Regulatory Affairs, Global Graphic Services, and others as needed.
4. Leads 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 and EU labeling mock-ups for use in submission to Health Authority.
6. Maintains labeling history documents.
7. Obtains and prepares labeling input for US Annual Reports.
8. Manages Labeling Change Controls.
9. Assigns National Drug Code (NDC) numbers and maintains NDC log for Janssen and Patriot Pharmaceutical US-marketed products.
10. Enumerates Global Trade Identification Numbers (GTIN) for Janssen and Patriot Pharmaceutical US-marketed products.
11. Supports Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) for US-marketed products.
12. Supports the Legal Department with litigation efforts related to GL CoE managed labeling, as needed.
Provides feedback on US Product Quality Complaints (PQC) related to product labeling and packaging artwork.
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