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    Duties

    Summary

    This position is located in the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), Office Of Study Integrity and Surveillance (OSIS), in Silver Spring, Maryland.

    OSIS ensures data supporting regulatory decisions is reliable by conducting and directing inspections of bioavailability/bioequivalence (BA/BE) and nonclinical (GLP) studies submitted to FDA.

    Learn more about this agency

    Responsibilities

    • Provide scientific expertise in the area of pharmaceutics, and pharmacokinetics, and clinical pharmacology.
    • Apply in depth knowledge of chemistry, biology, pharmacokinetics, physiology, clinical pharmacology/pharmacy and medical science in the review of Investigational New Drugs (INDs), New Drug Applications (NDAs), and Form 5 applications.
    • Arrange for and act as a Project Officer on extramural contracts to resolve problems encountered in the review procedures.
    • Remain cognizant of developments in the field, exchange ideas with other scientists.
    • Maintain awareness of the state of the art through continuing review of the scientific literature and studies of precedent setting investigations to develop specific approaches to assigned area of responsibility.

    Travel Required

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

    Supervisory status

    No

    Promotion Potential

    13

  • Job family (Series)

    0405 Pharmacology

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/519352600. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.