Make it happen
YOU...
1. are responsible for planning and coordinating the labeling, packaging, and release of investigational medicinal products (IMP) for global clinical programs, including Investigator Initiated Trials (IITs)
2. ensure regulatory compliance in IMP label text translations and providing consultancy to CTS study teams on packaging
3. manage material master data, packaging plans, and demand for packaging components, while overseeing SAP-based packaging orders and coordinating test sample supplies
4. ensure compliance with country-specific regulations by generating and maintaining study-specific label text and coordinating label printing
5. support global departments in IITs by consulting on packaging design, managing supply concepts, and coordinating the delivery of packaged products
6. oversee quality aspects such as SOP development, change management processes, and contributing to audits and inspections
7. lead meetings with global CTS study teams and external providers to define packaging and labeling strategies, and participating in relevant study team and CTS meetings
Be our forward thinker
YOU...
8. have University Degree in Logistics or Economics or relevant professional experience
9. have very good knowledge of clinical supply packaging processes, in GMP, GDP and GCP regulations
10. are familiar with the international regulations regarding labeling of investigational medicinal products
11. know how to work in a matrix structure
12. speak English fluently
A home where people learn and thrive
13. Permanent Employment
14. Attractive Salary
15. Mobile working in consultation
16. Individual Trainings
17. Flexible Working Hours
18. Employee Events
19. Wellpass