Global Labeling Contractor (Remote)

This mid-sized, global biopharma company has multiple approved products and a strong pipeline of biotherapeutics. They are seeking a Global Labeling Contractor to handle various labeling activities for a short-term engagement. This position will be 30-40 hours a week for approximately six weeks.  This is a remote/work from home position!

Responsibilities:

  • Implementation of new and updated Company Core Data Sheets (CCDS’s).
  • Timely provision of all required labeling documents needed by the Region for submissions to Health Authorities where product label is affected.
  • Collecting, understanding, and communicating Health Authority requirements and opportunities related to product labeling for new drug applications as well as licensed products for the assigned regions.
  • Interact with relevant stakeholders including the CCDS owners, regional points of contact, and local commercial organizations, as applicable.
  • Ensure compliance with the regional and country-specific regulatory requirements and procedures governing leaflets and labeling. Ensure compliance of region/country specific labeling texts with the CCDS.
  • Track region/country specific deviations from the CCDS and brings these deviations to the attention of the CCDS owner for decision making.
  • Ensure that printed packaging materials are updated subsequent to labeling changes.
  • Maintain labeling databases and systems as needed.

Knowledge and Skills:

  • Bachelors degree in a scientific discipline; Advanced degree preferred.
  • At least 4-5 years of regulatory experience in Labeling for pharmaceuticals or biologics.
  • Experience with maintenance of Labeling texts and Company Core Data Sheets.
  • Competence in documentation practices
  • Planning, organizing and time management skills
  • Attention to detail
  • Ability to work well under pressure
  • Understanding of GMP compliance, quality control procedures and documentation practices
  • Excellent oral, written and interpersonal communication skills

 

NOTE:  All candidates/contractors must be authorized to work in the United States.  We cannot provide US work authorization, nor can we support corp-to-corp contractors.

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