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Clinical Supply Packaging Specialist

vor 2 Monaten

Marburg an der Lahn, Hessen, Deutschland OSB AG Vollzeit

Join Our Team as a Clinical Supply Packaging Specialist

Your Role:

  • Take charge of planning and orchestrating the labeling, packaging, and distribution of investigational medicinal products (IMP) for international clinical initiatives, including Investigator Initiated Trials (IITs).
  • Ensure adherence to regulatory standards in IMP label text translations while providing expert guidance to study teams on packaging matters.
  • Oversee material master data, packaging strategies, and the demand for packaging components, while managing SAP-based packaging orders and coordinating test sample provisions.
  • Guarantee compliance with local regulations by generating and maintaining study-specific label text and coordinating the printing of labels.
  • Support global departments in IITs by advising on packaging design, managing supply concepts, and coordinating the delivery of packaged products.
  • Supervise quality aspects, including the development of Standard Operating Procedures (SOPs), change management processes, and contribute to audits and inspections.
  • Lead discussions with global study teams and external partners to establish packaging and labeling strategies, while actively participating in relevant study team and CTS meetings.

Your Profile:

  • Possess a University Degree in Logistics, Economics, or relevant professional experience.
  • Demonstrate a strong understanding of clinical supply packaging processes, including GMP, GDP, and GCP regulations.
  • Familiarity with international regulations concerning the labeling of investigational medicinal products is essential.
  • Ability to navigate a matrix organizational structure effectively.
  • Fluency in English is required.

What We Offer:

  • Permanent employment with a competitive salary.
  • Flexible working arrangements in consultation.
  • Opportunities for individual training and development.
  • Flexible working hours to support work-life balance.
  • Engaging employee events and activities.
  • Access to Wellpass for wellness initiatives.