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Labeling Project Coordinator II at Insight Global

Labeling Project Coordinator II

Insight Global Santa Monica, CA Full-Time
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An employer is seeking a Clinical Lebeling Coordinator for one of our largest biopharma clients sitting in Santa Monica. This individual is expected to be a hardworking leader that encourages teams while providing technical expertise in a dynamic pharamceutical clinical labeling environment. He or she will work collaboratively with other members of Clinical Labeling, Quality, Clinical Operations, Package Engineering, Supply Chain, Regulatory and Project Management staff to meet project deliverables.

Specific Job Requirements:
  • Responsible for processing clinical labeling documents and completing activities associated with multiple clinical development programs. These include but are not limited to label generation and approval per regulatory guidelines.
Interacts with Kite internal cross-functional teams to provide input into labeling options
  • Engages the clinical labeling group to meet company goals including department improvement projects
  • Works closely with ancillary groups to process and approve GMP documents
  • Authors and reviews documents to ensure GMP compliance
  • Responsible for change control task closures and preliminary assessments
To learn more about how we collect, keep, and process your private information, please review Insight Global Privacy Policy: [ Link removed ] - Click here to apply to Labeling Project Coordinator II
  • Project and document management experience
  • Experience with Change Control
  • Able to anticipate client obstacles and difficulties and act upon this in order to meet goals.
  • Ability to write clear, concise and error-free documents.
  • Able to exercise discernment within defined procedures and policies in order to resolve and take appropriate action.
  • Possess a knowledge of the GDP, cGMP, FDA standards as well as regulatory mentorship documents such as Annex 13.
  • Prior experience with clinical labeling, including the technical aspects of label design, is preferred
  • Requires a Bachelor's degree and a minimum 2 years of relevant industry experience preferably in clinical labeling

Recommended skills

Certified Global Meeting Planner
Good Manufacturing Practices
Document Management Systems
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Job ID: LAX-418295

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