Clinical Supply Chain Manager

vor 2 Wochen

Marburg an der Lahn, Hessen, Deutschland OSB AG Vollzeit

**About the Role**

As a Packaging Operations Specialist at OSB AG, you will play a critical role in ensuring the smooth planning and coordination of labeling, packaging, and release of investigational medicinal products for global clinical programs.

**Key Responsibilities**

  • Plan and coordinate the labeling, packaging, and release of investigational medicinal products for global clinical programs, including Investigator Initiated Trials (IITs).
  • Ensure regulatory compliance in IMP label text translations and provide consultancy to CTS study teams on packaging.
  • Manage material master data, packaging plans, and demand for packaging components, while overseeing SAP-based packaging orders and coordinating test sample supplies.
  • Ensure compliance with country-specific regulations by generating and maintaining study-specific label text and coordinating label printing.
  • Support global departments in IITs by consulting on packaging design, managing supply concepts, and coordinating the delivery of packaged products.
  • Oversee quality aspects such as SOP development, change management processes, and contributing to audits and inspections.
  • Lead meetings with global CTS study teams and external providers to define packaging and labeling strategies, and participate in relevant study team and CTS meetings.

**Requirements**

  • University Degree in Logistics or Economics or relevant professional experience.
  • Very good knowledge of clinical supply packaging processes, in GMP, GDP, and GCP regulations.
  • Familiarity with the international regulations regarding labeling of investigational medicinal products.
  • Ability to work in a matrix structure.
  • Fluency in English.

**What We Offer**

  • Permanent Employment.
  • Attractive Salary.
  • Mobile working in consultation.
  • Individual Trainings.
  • Flexible Working Hours.
  • Employee Events.
  • Wellpass.

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