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  • Job Type
    Full-time Position
  • Background
    Biotech and Agricultural
    Creative and Design
    Management & Business Others
    Medical and Healthcare
    Others
  • Category
  • Languages
    English
  • Experience Required
    6 - 10 Years
  • Degree Required
    Bachelor
    • Province
      5,421 reviews
    • Date Posted
      May 06,2021
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    Associate Director Global Labeling Implementation

    Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting Associate Director, Global Labeling Implementation (GLI) within the Global Labeling Centre of Excellence. The position can either be remote or based at any of the following Janssen R&D sites: US (Titusville, NJ, Raritan, NJ or Spring House, PA), Canada (Toronto, Ontario), UK (High Wycombe), Netherlands (Leiden), or Belgium (Beerse) or remotely.

    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.

    Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.

    Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It’s a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

    The Associate Director, GLI, provides leadership and strategic direction for the planning and execution of approved packaging graphics and related labeling deliverables focused on US-marketed pharmaceutical products.

    The role is responsible for the development of text for printed packaging components and supports artwork development, review, and approval for assigned products in compliance with applicable Health Authority and other external requirements as well as Janssen processes and standards.

    The Associate Director, GLI will provide management and oversight of:

    • The preparation, review, approval, and implementation of US-related artwork, in coordination with cross-functional business partners including Regulatory Affairs, Graphics, Package Engineering, Supply Chain, and Business Quality.
    • The development, review, and approval of registration labeling and select international artwork.
    • The timely completion of labeling inputs for US Annual Reports.
    • National Drug Code (NDC) and Global Trade Identification Number (GTIN) assignment and enumeration for new products and/or package configurations.
    • US Establishment registration and Structured Product Labeling (SPL).
    • Responses to artwork-related Product Quality Complaints (PQC).
    • Inputs for labeling-related escalations and CAPAs.

    As a member of the GLI Leadership Team, the Associate Director, GLI, will:

    • Conduct periodic labeling gap assessments to ensure processes and metrics align with expectations and business needs.
    • Develop improvement plans based on opportunities and gaps. Communicate openly across team members and stakeholders to ensure alignment on goals.
    • Develop, monitor, and manage budget, workload, vendor deliverables, and resources.
    • Coach and train direct reports in labeling regulations and guidances, with a focus on developing excellence in labeling processes, standards, and compliance.
    • Builds talent by giving constructive feedback on performance, including clear direction on goals and objectives.
    • Perform people management tasks such as Performance Management, Compensation, and Career Planning.
    • Ensure team is prepared for audits and inspections; support audits and inspections as needed.

    Qualifications

    Qualifications

    • A minimum of Bachelor’s degree (or equivalent) is required
    • 8 years relevant health regulated industry experience is required
    • A minimum of 2 years of experience working in a labeling function or in a labeling related function (e.g. regulatory affairs, RSMO, supply chain) is required
    • Previous experience working directly in labeling operations is beneficial
    • Thorough knowledge of drug/medical device labeling regulations is desired.
    • A minimum of 2 years of people management experience is required.
    • End-to-end labeling knowledge is required
    • Knowledge of US FDA requirements for pharmaceutical labeling and packaging is required
    • Process Improvement knowledge and experience as a change leader is required
    • Track record of leading projects through to successful completion is required
    • Experience working with and/or leading cross-functional teams is required
    • Experience working with external providers is an asset
    • Experience with labeling submission planning and implementation is an asset
    • Knowledge of electronic artwork management systems is beneficial
    • Experience using or managing use of electronic document comparison technology is an asset
    • Understanding of Supply Chain concepts and terminology related to labeling implementation is desirable
    • Strong verbal and written communication, negotiation, and partnering skills is required

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



    Primary Location
    United States-New Jersey-Raritan-920 US Highway 202
    Other Locations
    United States-New Jersey-Titusville, United States-Pennsylvania-Spring House, Canada-Ontario-Toronto, Belgium-Antwerp-Beerse, United Kingdom-England-High Wycombe, Netherlands-South Holland-Leiden
    Organization
    Janssen Research & Development, LLC (6084)
    Job Function
    Regulatory Affairs
    Requisition ID
    2105920768W
     
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