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Posted: Friday, September 1, 2017 2:44 PM

Description

Janssen Research & Development, LLC is recruiting for a Global Labeling Manager that will be located in Titusville, NJ or Raritan, NJ.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

The Global Labeling Manager leads labeling submission planning and implementation activities on behalf of Janssen R&D Global Labeling Centre of Excellence (GL CoE). The Global Labeling Manager makes decisions that have an impact on the planning and implementation of labeling documents. Also, makes decisions and recommendations that will have an impact on direct reports.

• 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.
• Creates and manages labeling project tracking entries as needed in departmental labeling trackers.
• 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.
• 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
• Manages US and EU labeling mock-ups for use in submission to Health Authority.
• Maintains labeling history documents.
• Obtains and prepares labeling input for US Annual Reports.
• Manages Labeling Change Controls.
• Assigns National Drug Code (NDC) numbers and maintains NDC log for Janssen and Patriot Pharmaceutical US-marketed products.
• Enumerates Global Trade Identification Numbers (GTIN) for Janssen and Patriot Pharmaceutical US-marketed products.
• Supports Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) for US-marketed products.
• Provides feedback on US Product Quality Complaints (PQC) related to product labeling and packaging artwork.
• Manages and trains direct report(s) and is responsible for employee development, oversight, and performance management.
• This position works independently and as a member of a team when making recommendations and decisions.

Qualifications
• A minimum of a Bachelor’s Degree with 6 years of relevant experience (including 2+ years health care industry) is required.
• People management experience is preferred.
• Strong verbal and written communication, negotiation, and partnering skill is required.
• E2E labeling knowledge is required.
• Process Improvement knowledge is required.
• Track record of managing projects through to successful completion is required.
• Experience successfully working with and/or leading cross-functional teams is required.
• Experience working with external providers is required.
• Experience with labeling submission planning and implementation is required.

Primary Location
United States-New Jersey-Titusville
Other Locations
North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Regulatory Affairs
Requisition ID
9099170830

Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=9099170830&lang=en


• Location: South Jersey, Titusville

• Post ID: 43735808 southjersey
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