Label Editor

Waukegan, IL

Post Date: 08/31/2017 Job ID: 23466 Category: Professional

Position Description:
  • The Label Editor is accountable for the development, editing, approval, and control of pharmaceutical labeling manufactured in US/Puerto Rico regional plants and third party manufacturers.
  • The position is also responsible for the creation and maintenance of labeling related specifications.
  • The applicant must have the ability to assess the impact of a label change on other product labeling and manufacturing operations and assure compliance with FDA regulations and cGMP s.

Major Responsibilities:
  • Manage and maintain labeling for assigned product lines. Initiate, prepare, review, approve and implement new or revised labeling.
  • Assure label content meets corporate, Regulatory and FDA requirements.
  • Have the ability to interpret governmental regulations and have a basic understanding of the requirements for pharmaceutical labeling.
  • Evaluate the impact of a labeling change on associated labeling and manufacturing operations.
  • Create label copy for new drug applications (NDA s) and ensure product filings have complete and accurate label content.
  • Upon FDA approval, manage the flawless execution of approved labeling to meet operational goals.
  • Review proposed changes to regulations, USP/NF or FDA Guidelines, and determine impact to labeling.
  • Initiate and manage changes to assure compliance.
  • Explore and implement continuous improvement opportunities that increase efficiencies and reduce cycle time.
  • Communicate and negotiate label implementation with Regulatory Affairs and plant Operations.
  • Participate on project teams representing Label Control for new product launches, labeling related projects, and/or new package designs.
  • Ability to interpret governmental regulations and have a basic understanding of the requirements for pharmaceutical and animal health product labeling.
  • Assist Marketing, as required, in the development of label designs for packaging commodities.

A-Line Staffing Solutions

877-782-3334

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