Labeling Project Manager

Location: Cambridge, Massachusetts, United States
Salary: competitive
Job Type: Contract
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Title: Labeling Project Manager

Contract Length: 02/17/2020 to 12/31/2020

Location: Cambridge, MA

A pharmaceutical company is seeking to bring on a Labeling Project Manager. The Labeling Project Manager is responsible for all activities associated with the development, creation and execution of labeling for assigned product lines for domestic and/or international markets. This position interacts with internal functional groups (e.g., Packaging Development, Quality, Inventory and Planning, and Regulatory Affairs) and third-party suppliers (print vendors, drug product packagers). The Labeling Project Manager is the Labeling Operations representative on project teams during the development and approval process of commercial product labeling.

ACCOUNTABILITIES:

  • Maintains overall responsibility for all creation, revision and maintenance of labeling materials (i.e., artwork and ancillary specification documentation) associated with marketed pharmaceutical products through interactions with advertising agencies, external graphics design studios, print vendors Global Regulatory Labeling, regional artwork suppliers and international functions as applicable.
  • Participates as Labeling lead on cross-functional project teams
  • Ensures the control of printed copy through the approval and distribution of controlled label artwork proofs, printed item specifications, implementation instructions to print vendors and contract packagers.
  • Ensures technical accuracy and production readiness for all labeling materials associated with assigned product lines Provides back-up/overflow support for Labeling team projects
  • Modifies style guidelines for new labeling initiatives due to business model changes or emerging regulatory changes.
  • Identifies efficiency and continuous improvement opportunities.
  • Creates, revises and approves GMP compliant SOP's to align with new and established policies and procedures.
  • Oversees vendor performance through management of labeling change projects, product launches, and by attending supplier audits and occasional site visits
  • Oversee and direct proofreading activities in support of labeling projects. Additional duties as assigned

EDUCATION, EXPERIENCE AND SKILLS: (List the education and experience required to perform the primary responsibilities of the job. Equivalent combinations of education and experience should be noted).

  • Bachelor's degree or 10 years relevant labeling and/or graphics experience
  • Minimum of 5 years' experience in pharmaceutical label development
  • Strong knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, and Product Labeling.
  • Strong knowledge of print manufacturing processes and printing graphics techniques
  • Strong knowledge of packaging process and operations
  • Flexibility to manage constantly shifting deadlines, varying deliverables, and communication complexities.
  • Excellent communication skills, both oral and written
  • High attention to detail
  • Ability to work in a team environment

PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).

TRAVEL REQUIREMENTS:

  • Less than 10% travel required
  • Day trips to local third-party vendors requiring drives of up to 3 hours
  • Occasional domestic flights and overnight stays may be required

Sthree US is acting as an Employment Business in relation to this vacancy.

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