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Clinical Trial Associate

Salary undisclosed

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Job Tittle: Label Development Specialist

Duration: 12 Months

Location: Ridgefield, CT (Hybrid work)

Job Duties:

The Label Development Specialist is accountable for processing, planning, monitoring and steering of timelines, tasks and costs for labeling activities performed at internal or at the packaging & labeling vendor supporting global clinical trials phase I – IV. The Label Development Specialist ensures within the Global Trial Team the timely provision of all kinds of IMP labels for assigned trials by communicating and negotiating all labeling related activities.

Tasks & Responsibilities:

  • Autonomously review of Master Label Text drafts considering regulatory requirements, standard text phrases and trial specifics.
  • Autonomously prepare country specific label text for translation of attending countries.
  • Autonomously review and check translated label text considering local requirements.
  • Autonomously review and check generated print proofs and distribute proofs to countries for check and approval.
  • Autonomously work in conjunction with global Trial Teams, Regulatory Affairs, Medicine and label vendors to create, define and optimize labeling related tasks.
  • Hold PLM internal and external team and pack & label vendors responsible for keeping their timeline and providing overview on the IMP pack & label milestones to the global trial team as well as ensures appropriate and effective communication to all functions.
  • 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. PLC-L Specialist acts as main contact for vendors and countries.
  • Contact person for all upcoming questions during the label process.

Skills:

  • Background in Clinical Trials (Supply Chain, Clinical Trial Regulations, Packaging and Labeling area, medical documentation)
  • Experience with labeling needs & processes i. e. Food industry
  • Demonstrates knowledge of all areas of clinical supply chain activities and a thorough knowledge and understanding of applicable regulations (e. g. CTR 536/2014)
  • Solid project management skills
  • Ability to interpret standard and complex project requirements
  • Strong problem solving, risk assessment and troubleshooting skills
  • Work independently and in a global team environment
  • Strong computer skills (e. g. Microsoft Office)
  • Fluency in English

Education:

  • Master’s Degree with experience in a related field or professional training with extensive experience in a related field
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