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    Duties

    Summary

    This position is located in the Center for Biologics Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT) located in Silver Spring, MD.

    This vacancy is also being announced concurrently with vacancy announcement FDA-CBER-18-DE-10191117 under delegated examining procedures. Please review that announcement to see if you are eligible for consideration under delegated examining procedures. Applicants must apply separately for each announcement in order to be considered under both.

    Additional selections may be made within the same geographical area FDA-wide.

    Learn more about this agency

    Responsibilities


    The incumbent of this position will:

    • Evaluate and interpret preclinical data, which contributes to complex, long range, and emerging issues of both a scientific and regulatory nature.
    • Review and evaluate the biomedical engineering, toxicological and pharmacological data contained in Investigational New Drug (IND) submissions and Investigational Device Exemptions (IDE), as well as amendments and supplements, respectively, to support the safety of cell therapy, gene therapy, and tissue-engineered products that are regulated by CBER/OTAT.
    • Exchange ideas with other peers in the scientific and regulatory communities engaged in related areas.
    • Evaluate the effects of the investigational cell therapy, gene therapy, or tissue-engineered product on organ systems, tissues, cells, and animals.

    Travel Required

    25% or less - You may be expected to travel for this position.

    Supervisory status

    No

    Promotion Potential

    13

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/499292400. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.