Manager, Global Gx and Biosimilar Clinical Supply Chain
Provides input for clinical study team in order to define study timelines, kit design and supply planning. Writes or Reviews Study Pharmacy Manuals and Clinical Supply Study Plans. Plans the secondary packaging and facilitates the process for final drug release. Initiates Investigational Medicinal Product label generation and oversees approvals, label regulatory adaptation and translations activities in collaboration with CRO and 3rd party vendors. Responsible for the CMC collection of documents for CTA submission.
Plans the IRT (Interactive response technology) system set-up (UAT, EDC Integrations) and oversees maintenance. Maintains the interaction with CROs, CMOs and other vendors to execute the business requirements of the CSC operational activities. Trains Clinical Sites or CRO delegates in all CSC Activities.
5+ years’ experience in pharmaceutical or clinical supply chain related field
Knowledge in managing Investigational Medicinal Product in Double Blinded studies.
Familiarity with Trial Master File contents and structure, possibly Veeva
Veeva
MS Word
Record Keeping Skills
Time Management Skills
MS Excel skills
Clinical Protocols
Motivated, self-directed and driven
Problem-Solving
Strong organizational skills
Flexibility/Adaptability
Attention to detail and accuracy
Verbal and Written Communication
Multi tasker
According to JobzMall, the average salary range for a Manager, Global Gx and Biosimilar Clinical Supply Chain in 400 Interpace Pkwy, Parsippany, NJ 07054, USA is between $110,000 and $145,000 per year. This salary range may vary depending on the individual's experience and qualifications.
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Teva Pharmaceutical Industries Ltd., also known as Teva Pharmaceuticals, is an American Israeli pharmaceutical company with dual headquarters in Petah Tikva, Israel and Parsippany, New Jersey, U.S. Teva Pharmaceutical Industries Ltd. engages in the provision of pharmaceutical services. It operates through the following business divisions: Generic, Specialty Medicine, and Over-the-Counter (OTC).
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