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Clinical Supply Chain Manager

Edison-New Brunswick Metro Area, NJ

Posted: 10/30/2018 Job Type: Clinical Job Number: JN -102018-22936
  • Minimum Requirements
    Bachelor s Degree
    At least 6+ years of Clinical Supply / Clinical Packaging / Project Coordination experience in the pharmaceutical/device industry or CRO
    Knowledge cGMPs and relevant FDA Regulations essential
    Excellent communication and writing skills

  • Independently coordinates clinical supply activities for clinical studies in support of development programs. These activities include review of clinical study protocols, design of clinical labels, preparation of packaging and labelling contracts, and forecasting and ordering supplies. Must coordinate the efforts of Clinical Trial Supplies Packaging with Clinical Supplies Manufacturing, Clinical Research, Pharmaceutical Development, Quality Assurance, and Regulatory Affairs with the objective of establishing a plan to have clinical supplies available within the agreed time frame.

    Key Duties / Responsibilities
    Role: Develops and implements the initial timeline, budget, drug supply forecasts and component requirements needed for preparation of the Clinical Supply Master Plan for Phase I through IV clinical protocols Oversight: No oversight
    -Effectively organizes and conducts meetings, and demonstrates facilitation and listening skills
    -Consistently demonstrates skills for evaluating customer needs and offering alternatives to accomplish project goals
    -Represent GCSM at CMC/Clinical meetings to update and forecast the status of projects
    -Reviews Clinical Research Development programs and coordinates development of yearly clinical supplies forecasts and supply plans
    -Protocol interpretation and breakdown
    -Demonstrates planning, project management, negotiation and presentation skills
    n a team or matrix environment

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