Job Listing
Office Director, Office of Surveillance and Epidemiology
Food and Drug Administration · Posted 63 days ago
About the Role
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 6, Band G. .
What You'll Do
- →Directs budget planning, resource allocation, and fiscal oversight for office programs.
- →Reviews funding and staffing needs, recommends budget actions, and ensures efficient, cost-effective operations aligned with organizational priorities.
- →Serves as senior advisor on epidemiology, drug safety, and population health.
- →Develops policy, resolves complex issues, and advises FDA leadership and external partners on regulatory and public health matters.
- →Directs analysis and implementation of new laws, regulations, and policies affecting office programs.
- →Recommends organizational and operational changes to strengthen the Office's mission and regulatory effectiveness.
- →Leads high-priority drug safety initiatives and special projects that advance postmarket surveillance, regulatory science, and public health objectives.
- →Oversees postmarket drug safety programs and multidisciplinary staff conducting safety analyses using FAERS and other data sources to identify, assess, and address safety concerns.
- →Provides executive leadership for FAERS enhancements and electronic reporting.
- →Advises on regulatory issues, supports compliance activities, and represents OSE on key pharmacovigilance and labeling workgroups.
- →Reviews epidemiologic study designs, protocols, reports, and datasets submitted by industry to ensure scientific rigor and support evaluation of postmarket drug safety.
- →Oversees review of adverse event reports and collaborates with CDER offices to evaluate marketed drug safety and recommend appropriate regulatory actions.
- →Partners with OSE leadership to develop strategic plans, allocate resources, and guide decisions affecting office programs, priorities, and operations.
- →Represents OSE with Congress, federal agencies, industry, professional organizations, and other stakeholders.
Requirements
- ✓Ethics Clearance Requirements This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation.
- ✓If you are hired, you may be required to divest of certain financial interests.
- ✓You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.
- ✓For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
- ✓Education Requirements: Degree: Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent from a school in the United States or Canada.
- ✓This degree must have been accredited by the Council on Medical Education of the American Medical Association(external link); Association of American Medical Colleges(external link); Liaison Committee on Medical Education(external link); Commission on Osteopathic College Accreditation of the American Osteopathic Association(external link), or an accrediting body recognized by the U.S.
- ✓Department of Education(external link) at the time the degree was obtained.
- ✓Degree from Foreign Medical School: A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States.
- ✓Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates(external link), a fifth pathway certificate for Americans who completed premedical education in the United States and graduate education in a foreign country, or successful completion of the U.S.
- ✓Medical Licensing Examination.
- ✓Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.
- ✓TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements.
- ✓You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
- ✓Education must be accredited by an accrediting institution recognized by the U.S.
Personality Fit
Job ID: 27b6e7fd-b57d-4d83-bbde-d81ed843bb01
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