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Regulatory Health Project Manager


Summary:

The Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Medical Products and Tobacco, Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE), located in Silver Spring, MD.

The Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) regulates the manufacturing, marketing, and distribution of tobacco products. Our goal is to reduce the harm from all regulated tobacco products across the entire population, including: reducing the number of people who start to use tobacco products, encouraging more people to stop using these products, and reducing the adverse health impact for those who continue to use these products. CTP's actions have significant public health and consumer protection impact and are among the most important issues faced by the Agency in its long and distinguished history.  

Responsibilities/Job Duties:

  • 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.
 

Basic Requirements:

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.

Minimum Qualifications:

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.

OR

I 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.

NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.

To return to an incomplete application, log into your USAJOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account, or your application will be incomplete.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 06/29/2020. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.

Education

You MUST submit a transcript which includes list of courses, grades, completion dates, and quarter or semester hours earned by the closing date of the announcement.