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regulatory affairs in Chicago

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  1. Senior Clinical Research Associate

    We are looking for CRAs with at least 6 years monitoring experience and 3-4 years in Oncology .  .   Responsibilities: MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits).  Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations.  Maintains regular review of site regulatory binder and ensures proper storage, ...

  2. ASSOCIATE DIRECTOR REGULATORY AFFAIRS

    Our client is currently seeking a ASSOCIATE DIRECTOR PRODUCT REGULATORY AFFAIRS. Bachelor Degree minimum requirement, Master Degree, PhD, or RPh strongly preferred. Must have at least ten years of experience in the pharmaceutical industry or relevant medical device experience as needed for the position. Must have experience working directly with regulatory agencies. Sound knowledge of applicable portions of global regulatory guidance and regulations. Must have had strong communications with the FDA ...

  3. Senior Clinical Research Associate

    We are looking for a Midwest CRA with Oncology and Infectious disease.  Must have both therapeutic areas to be considered.   Responsibilities: MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits).  Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations.  Maintains regular review of site regulatory binder and ...