Job Description

**HIRING ON SITE IN SEVERAL LOCATIONS**

Little Rock, AR; Columbus, OH; Oklahoma City, OK; Pittsburgh, PA, Dallas, TX; Falls Church, VA

Summary:

The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) Office of Medical Products and Tobacco Operations (OMPTO), Office of Bioresearch Monitoring Operations (OBIMO) and being filled under FDA’s Title 21 hiring authority. This hiring authority was passed by Congress in December 2016, to improve FDA’s ability to recruit and retain scientific, technical, and professional experts in certain occupational series that “support the development, review, and regulation of medical products.” The FY23 Omnibus Appropriations Bill expanded the hiring authority to include cross-cutting positions and individuals that support the development, review, and regulation of food and cosmetics in addition to medical products. Both statutes amended the FD&C Act 21 USC. This hiring authority is a streamlined hiring authority, outlined in 21 USC 379d-3a, as amended by the 21st Century Cures Act of 2016, § 3072 and the Consolidated Appropriations Act of 2023, § 3624.

This job is open to: Open to the Public

Hiring Path Clarification Text:

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

Duties

The Investigator II (Band A) / Senior Investigator I (Band B) has demonstrated and is recognized for a high level of competence in the full range of establishments regulated within the OBIMO program such as: clinical investigators, nonclinical laboratory facilities, sponsors, contract research organizations, institutional review boards, post marketing adverse drug experience reporting, and risk evaluation and mitigation strategies.

Assignments involve a combination of scientific and regulatory responsibilities which usually call for several atypical inspectional or intensive investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations; and include the most difficult and complex sample collections, establishment inspections, unusual or novel special investigations and conducting objective surveys and emergency activities within the assigned area of responsibility. The Investigator II will also perform international inspections.

Inspections and Investigations

• Assignments cover large, medium, and small firms, complex investigations and inspections of various industry establishments covered by the program such as: clinical investigators, sponsors, contract research organizations, institutional review boards, nonclinical laboratories, post marketing adverse drug experience reporting, and risk evaluation and mitigation strategies. The Investigator II independently conducts inspections, investigations, and sampling where new or unusual features are present, only limited guidance documents are available; proposed or new regulations must be used to evaluate the industry; or the inspection or investigation may result in considerable attention and review in the media, the Department, Congress, or other forces inside or outside the Agency. Inspections cover all types of products and problems within the area of assigned responsibility.

• Investigates and evaluates the adequacy of complex practices to determine compliance with the regulations.

• Incumbent interacts with and advises various levels of officials representing the establishments subject to regulatory review. The incumbent initiates contact with industry officials to obtain information on regulatory and scientific documents and to discuss the status of investigations.

• Assists the immediate supervisor in planning inspections, investigations, sample collections, and related activities in the area of assigned responsibility; training new personnel and higher graded personnel, as appropriate; training foreign government personnel. Developmental assignments include assisting higher level employees in inspections or other field activities, meetings, and conference calls with regulated industry.

• Incumbent conducts re-inspections to follow up with non-compliant industry establishments on previously noted violations. In situations where compliance is not offered, it is enforced through other methods, including administrative action, informational agency meetings, and legal court actions.

Analysis and Reporting

• The Incumbent will perform analyses and evaluation on data samples and documented information gathered during inspections and investigations to ensure that documentation and practices are in compliance with Federal laws, rules, and regulations. Documents and organizes required evidence, data, and other information to support violations noted during inspections, investigations, and sample collections.

• Incumbent gathers scientific and technical comments from team members, assists with the preparation of reports relevant to the inspection, and contributes to status reports for inspections and investigations under review.

• Prepares final reports, position papers and other written documentation that support investigative findings and recommendations. Reports are developed and well-written in accordance with quality elements.

Supervisory Responsibilities: This is not a supervisory role.

How to Apply

Applications will be accepted by all qualified applicants. United States Citizenship is required. Applicants must submit a detailed current resume, and college transcript(s) showing degree was awarded (with foreign credentials evaluation if applicable). A diploma will not be accepted as part of your application. All required materials should be sent to: ORAInvestigatorHiring@fda.hhs.gov. Applications will be accepted through September 4, 2024, or until all positions have been filled.

IMPORTANT: Applicants must reference: 8-INV-OBIMO-A/B-name of preferred location(s) in the email subject line.

NOTE: It is your responsibility to ensure the job reference ID is noted in the subject line and the appropriate required documentation is submitted prior to the closing date for your application to be considered.

Announcement Contact

For questions regarding this T21 position, please contact ORAInvestigatorHiring@fda.hhs.gov. and include the following job reference ID in the subject line: 8-INV-OBIMO-A/B-Q.

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