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    Duties

    Summary

    This position is located in the Department of Health and Human Services, Food and Drug Administration, Office of Medical Products and Tobacco, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology, Division of Pharmacometrics, located in Silver Spring, MD.

    This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-18-DE-10166170JJ 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.

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

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    Responsibilities

    • Plan, manage, organize, and direct all regulatory review operations, program segments, functions, and activities of the Division as carried out by subordinate team leaders and a staff.
    • Ensure that reviewers provide quality review and consultation to customers within established timeframes for the science and administration functions of the Division
    • Evaluate budget, fiscal, and administrative controls to manage Division program segments and services.
    • Play a key leadership role in critical industry meetings, identifies issues related to pharmacometrics and collaborates with other disciplines to ensure that key questions and drug development issues are addressed.
    • Lead the preparation, clearance, and finalization of Division responses to inquiries covering all aspects of the programs, functions, and activities of the Division.
    • Provide oversight of the development of CDER's model-informed drug development initiatives, including services and operations in support of regulatory activities.
    • Serve as a full deputy to the Division Director in the absence of the Division Director, for all areas of responsibility assigned to the Division Director.

    Travel Required

    Not required

    Supervisory status

    Yes

    Promotion Potential

    15

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/495362900. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.