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Project Manager - CMC Biologics

Edison-New Brunswick Metro Area, NJ

Posted: 07/15/2019 Job Type: Scientific Job Number: JN -072019-25223
  • Bachelor s degree with a minimum of 7 years of experience 4-5 yrs. in Pharmaceutical Development and 2-3 yrs. in Project Management or equivalent. PMP certification preferred.
    Summary: This position will support the Biologics CMC Program Leadership function and Biologics CMC Project Teams. The Project Manager will be responsible for supporting the implementation of a knowledge management system for all biologics CMC projects in portfolio. He/she will work with the Biologics CMC Team Leads, technical subject matter experts, and CMC technical writing group to transition from the current document storage system into a new, more effective CMC project information system. The Project Manager may also support the day-to-day activities of one or more Biologics CMC teams. This role requires the ability to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within the organization.

    The roles and responsibilities include, but are not limited to, the following:
    With input from the Biologics CMC Program Leadership, Technical Writing lead, team leads, and team members, implement the transition to an electronic knowledge management system for biologics CMC documents.
    Work closely with team members and subject matter experts, providing guidance and support on how to effectively transfer documents into the knowledge management system and help ensure timely transfer and maintenance of content.
    Interface with team members to drive document transfer process, identify barriers for execution, an
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