Global Clinical Packaging Manager
vor 4 Wochen
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 worldwide clinical initiatives, including Investigator Initiated Trials (IITs).
- Ensure adherence to regulatory standards in IMP label text translations and provide expert guidance to study teams on packaging matters.
- Oversee material master data, packaging strategies, and the demand for packaging components, while managing SAP-driven packaging orders and coordinating test sample provisions.
- Guarantee compliance with country-specific regulations by generating and maintaining study-specific label text and facilitating label printing.
- Support global departments in IITs by advising on packaging design, managing supply concepts, and coordinating the delivery of packaged products.
- Supervise quality-related aspects such as SOP development, change management processes, and contribute to audits and inspections.
- Lead discussions with global study teams and external partners to establish packaging and labeling strategies, and actively participate in relevant study team and CTS meetings.
Your Profile:
- Possess a University Degree in Logistics, Economics, or equivalent professional experience.
- Demonstrate a strong understanding of clinical supply packaging processes, including GMP, GDP, and GCP regulations.
- Be knowledgeable about international regulations concerning the labeling of investigational medicinal products.
- Exhibit the ability to operate effectively within a matrix structure.
- Fluency in English is essential.
What We Offer:
- Permanent Employment.
- Competitive Salary.
- Flexible working arrangements in consultation.
- Personalized Training Opportunities.
- Flexible Working Hours.
- Employee Engagement Events.
- Wellness Programs.
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