Regulatory Health Program Coordinator
Summary
This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Tobacco Products (CTP), Office of Science (OS), Division of Regulatory Project Management (DRPM), located in Beltsville, Maryland.
Responsibilities
Compiles and analyzes data for reports and presentations utilizing knowledge of scientific regulatory program and project coordination and application review, records and other health-science related program and project information sources. Serves as a member of the review team, reviews, evaluates routine scientific submissions and applications for tobacco products. Performs library and document search of technical and scientific publications in all appropriate sources for drafting of replies to consumer, physician, attorney, congressional, tobacco industry, etc.Prepares draft letters to applications regarding administrative and regulatory issues based on input from the review staff; prepares minutes of internal applicant meetings and prepares other written communication as required. Ensures the scientific and regulatory programs and projects accomplish their goals and have proper planning, monitoring, and controlling to ensure efficient and successful initiation, execution, and closing.
Travel Required
25% or less - You may be expected to travel for this position.
Qualifications
The position of Regulatory Health Program Coordinator falls under the 0601 occupational series. To qualify for this position at grade GS-7/9, you must meet the following:
Basic 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 at the time the degree was obtained.
Minimum Qualifications
Specialized Experience. Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.
GS-7: Additional Requirements:
Applicants must have at least one year of specialized experience equivalent to the GS-5 grade level in the Federal service that includes assisting in providing basic scientific principles in carrying out scientific projects related to tobacco and/or other regulated products.
-OR-
One year of graduate-level education or superior academic achievement.
GS-9: Additional Requirements:
Applicants must have at least one year of specialized experience equivalent to the GS-7 level in the Federal service which includes participating in gathering and analyzing requested information for scientific projects and assisting with monitoring and reviewing submissions of tobacco and/or other regulated product-related information.
-OR-
Two years of progressively higher level graduate education leading to a master's degree or master's or equivalent graduate degree.
Salary
$49,157 to $78,167 per year
Pay scale & grade
GS 7 - 9