National Institutes of Health Office of Technology Transfer
Silver Spring, MD, United States
Jun 26, 2020
Oct 09, 2020
Regulatory Health Project Manager (June 29, 2020)
Food and Drug Administration, Center for Tobacco Products, Silver Spring, Maryland
Coordinates the tobacco product review process from initial submission to the time of regulatory action. Provides recommendations to all parties engaged or interested in the FDA tobacco product review process.
Ensures compliance with all legal, regulatory science and policy requirements. Initiates correspondence regarding regulatory action, policy issues, or requests for additional scientific information.
Works with all members of the review team (scientific, regulatory, and management) to develop program plans, including setting timeframes, milestones, and an agreed-upon endpoint.
Monitors and reports actual status of all activities within the assigned projects through interactions with project participants and, if necessary, supervisors and directors.
Conducts initial reviews of tobacco product applications and other submissions of scientific information to determine completeness, recommending scientific specialties needed for in-depth review.
Analyzes review status with respect to variance from program plans and determines impact on established program goals. Identifies and resolving resource needs or conflicts, availability and scheduling.
In order be eligible for the position of Regulatory Health Project Manager, (GS-0601-11/12), you must meet the following requirements...
Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained.
You must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level (GS-0601-11/12) in the Federal service.
GS-11: Possess at least one year of specialized experience equivalent to the GS-09 level in Federal service or public and private sectors, which includes assisting with applying scientific methods for tobacco products and/or other regulated products.
Have at least three full academic years of progressively higher level graduate education or Ph.D. or equivalent doctoral degree or L.L.M., if related. An academic year of graduate education is considered to be the number of credit hours that the school attended has determined to represent one academic year of full-time study. This determination is made based on normal course loads for a full year of study in the graduate program. If that information cannot be obtained from the school, 18 semester hours or 27 quarter hours should be considered as satisfying the 1 year of full-time study requirement.
GS-12: Must possess at least one year of specialized experience equivalent to the GS-11 level in Federal service, which includes applying knowledge of scientific methods and regulatory policies to manage regulated products research, applying project management principles in organizing concurrent activities and providing oral and written briefings and recommendations concerning projects.
Application Deadline Date: June 29, 2020
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