Job Title: Project Specialist, Clinical Packaging
Duration: 8 Months
Location: Jersey City, NJ
Requirements: -Bachelor’s Degree
-3-5+ years of Clinical Supply/Clinical Packaging/Project Coordination -Knowledge cGMPs and relevant FDA Regulations
-Must have experience in clinical supplies (protocol interpretation, forecasting, packaging/labeling, IVRS, distribution)
-Strong project management skills
-Develops and implements the initial timeline, budget, drug supply forecasts and component requirements needed for preparation of the Clinical Supplies Contract and Supply Order for Phase I through IV clinical protocols with minimal supervision -Participates on and/or leads Clinical Supplies Delivery Teams -Reviews Clinical Research Development Programs and coordinates development of yearly clinical supplies forecasts. -Protocol Interpretation and breakdown.