Radius Health, Inc.

  • Labeling Manager

    Job Locations US-PA-Wayne
    Posted Date 1 month ago(1 month ago)
    Job ID
    2018-1821
    # of Openings
    1
    Category
    Pharmaceutical Sci - Dept
  • Overview

    Radius is seeking to hire a Labeling Manager who will facilitate the implementation and approval process for GMP commercial artwork and the documentation for pre-commercial to commercial products.   This individual will manage the security efforts for anti-counterfeiting measures, support clinical packaging & labeling and champion labeling through the review and approval process as well as implementation.     The incumbent will interact cross-functionally with members of Regulatory Affairs, Commercial, Medical Affairs, Quality and others to develop, review, implement and provide systems support of GMP labeling and will integrate complex programs that may require multinational interactions and cross functional partnership.

    Responsibilities

    • Manage technical requirements of labeling to ensure it meets the technical standards/specifications for GS1, the contract manufacturer organizations (CMO)’s, printer, etc.
    • Coordinate and manage the change control process for all GMP labeling modifications.
    • Employ measures for counterfeit protection to implement overt and covert anti-counterfeiting technologies.
    • Manage internal documentation requirements including change controls specifications, item code creations, pertinent SOPs and artwork libraries. 
    • Coordinate review, obtain internal approvals and ensure labeling follows Quality system requirements, GMP and applicable domestic, international regulatory requirements and anti-counterfeiting provisions.
    • Along with Regulatory Affairs, coordinate artwork translations. 
    • Oversee generation of final proof copy/transparency proof and creation of print-ready artwork files 
      Serve as the primary information base for all issues related to product labeling/printed components and clinical packaging and labeling.
    • Ensure labeling artwork generated is in conformance with source text. 
    • Support Regulatory Affairs in packaging responses to Health Authorities. 
    • Tracking of all versions, specifications and coding for each labeling component for all GMP labeling.
    • Follow GS1 standards and UPC/GTIN number assignment.
    • Ensure US DSCSA and EU FMD implementation and compliance.
    • Support other Supply Chain staff for day to day logistics and inventory management.
    • Support AX ERP and Serialization management.  
    • Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function

    Qualifications

    • BS/BA degree is required (packaging engineering, supply chain, or similar); Masters is preferred. At least 5 years of related Industry experience is required.
    • Experience in cGMP packaging operations is required with knowledge of clinical trials operations preferred.
    • Candidates should have a strong understanding of US and EU regulations on labeling and packaging implementation.
    • Keen attention to detail and accuracy is important.
    • Excellent verbal and written communication skills in English is necessary.
    • Experience in packaging labeling development is preferred.

    Work Environment:

    The work is performed in a typical office environment with heavy computer duties.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually quiet.   Frequent travel required.

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents.  The employee is occasionally required to stand and walk.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. 

    Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

     

     

    PM18

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