Label Development Specialist

3 weeks ago


Ridgefield, Connecticut, United States Compunnel, Inc. Full time
Job Description

The Label Development Specialist plays a pivotal role in ensuring the timely provision of Investigational Medicinal Product (IMP) labels for global clinical trials (Phase I – IV). This specialist coordinates with global trial teams and packaging & labeling vendors to guarantee regulatory compliance and meet trial-specific needs. Key responsibilities include reviewing Master Label Text drafts, preparing country-specific label text for translation, and validating translated label text to ensure compliance with local regulatory requirements.

Key Responsibilities:
  • Independently review Master Label Text drafts to ensure compliance with regulatory requirements, standard phrases, and trial-specific details.
  • Prepare country-specific label text for translation and coordinate with global trial teams to meet trial-specific needs.
  • Review and validate translated label text to ensure compliance with local regulatory requirements and communicate with global trial teams.
  • Coordinate the distribution of generated print proofs to countries for review and approval.
  • Collaborate with global trial teams, Regulatory Affairs, Medicine, and vendors to create, define, and optimize labeling tasks.
  • Hold internal and external teams accountable for meeting timelines and milestones related to pack & label tasks.
  • Provide regular updates to the global trial team on label generation milestones and ensure effective communication across all functions.
  • Compile and provide complete label documentation for final release to the Release and Process Management Team.
  • Serve as the primary contact for external vendors and countries, ensuring all necessary documents are provided.


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