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Job Details

Zusammenfassung

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Job Details

Ihre Aufgaben

  • Autonomously review of Master Label Text drafts considering regulatory requirements, standard text phrases and trial specifics
  • Prepare country specific label text for translation of attending countries
  • Review and check translated label text considering local requirements
  • Review and check generated print proofs and distribute proofs to countries for check and approval
  • Work in conjunction with CTSU Trial teams, Regulatory Affairs, Global Randomization, Medicine and label vendors to create, define and optimize labeling related tasks
  • Hold PLC internal and external Team and pack and label vendors responsible for keeping their timeline and providing overview on the IMP pack and label milestones to the global CTSU trial team as well as ensures appropriate and effective communication
  • Compile and provide completed label documentation for final release to the Release and Process Management Team
  • Global PLC-L Specialist provides all relevant Documents like Master Label Text, Country List, Packaging Design, STORM Document and all other country and product specific information necessary to perform this task by external vendors
  • Contact person for all upcoming questions during the label process

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