Version: 11/2021

Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Office of Regulatory Affairs (ORA)

Office of Medical Products and Tobacco Operations (OMPTO)

Office of Bioresearch Monitoring Operations (OBIMO)

Investigator II

Application Period: January 10, 2024 – July 10, 2024

Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. 

National. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Investigator II Series: AD-0696

Location(s): Multiple vacancies in the following 

locations: Birmingham, AL; Alameda, CA; Long Beach, 

CA; Los Angeles, CA; San Diego, CA; San Francisco, CA; 

San Jose, CA; Woodland Hills, CA; Lakewood, CO; 

Hartford, CT; Wilmington, DE; Boca Raton, FL; 

Jacksonville, FL; Maitland, FL; Miami, FL; Tampa, FL; 

College Park, GA; Bannockburn, IL; Chicago, IL; 

Indianapolis, IN; Boylston, MA; Stoneham, MA; 

Detroit, MI; Minneapolis, MN; East Brunswick, NJ; 

Parsippany, NJ; Jamaica, NY; White Plains, NY; 

Brunswick, OH; Cincinnati, OH; Columbus, OH; 

Philadelphia, PA; Pittsburgh, PA; Providence, RI; 

Nashville, TN; Houston, TX; San Antonio, TX; Salt Lake 

City, UT; Falls Church, VA; Portsmouth, VA; Richmond, 

VA; Bothell, WA; Seattle, WA 

Work Schedule: Full Time

Salary: Starting at $82,764 (Band A)

 Starting at $99,200 (Band B)

Title 21 Band(s): Band A, Table 1 Full Performance Band Level: Band B

Travel Requirements: Up to 50% travel

Bargaining Unit: This is a bargaining unit position.

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 
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this position will serve under a career or career-conditional appointment and be paid under 

the provisions of this authority. Additional information on the 21st Century Cures Act can be 

found here: 21st Century Cures Act Information

Introduction

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health

and consumer protection agency responsible for ensuring all human and animal drugs, medical

devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing

animal, tobacco, and radiation emitting devices are safe, and that all such products marketed in

the United States are adequately, truthfully, and informatively labeled and safely and properly

stored, transported, manufactured, packaged, and regulated. FDA’s programs are national in

scope and effect, and the agency’s activities have a direct and significant impact on multibillion

dollar industries, in addition to protecting the health and safety of American Consumers. The

work of the Agency is carried out by a staff of more than 18,000 scientists, physicians,

regulatory and other personnel stationed throughout the United States.

The mission of the Office of Regulatory Affairs is to protect consumers/patients and enhance 

public health by ensuring timely access to safe, quality FDA-regulated products. To view our 

ORA Vision, Mission, and Values, please visit: https://www.fda.gov/about-fda/fdaorganization/office-regulatory-affairs. 

The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net 

for today’s complex, global regulatory environment. ORA professionals work in a range of 

program areas and locations, with 227 offices and 12 laboratories throughout the United 

States. As the lead office for all FDA field activities, ORA serves as the agency’s direct 

connection with regulated industry through a) inspections of firms and plants producing FDAregulated products, b) investigations of consumer complaints, emergencies and criminal 

activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of 

imported products.

The FDA's Office of Bioresearch Monitoring Operations (OBIMO) is the lead office for 

conducting inspections and investigations of clinical and nonclinical research performed in 

support of marketing applications for regulated products, as well as post marketing adverse 

drug experience reporting and risk evaluation and mitigation strategies for approved products. 

OBIMO works with all six product centers to develop policies on compliance and enforcement 

and is responsible for the following: Inspecting foreign and domestic bioresearch monitoring 

establishments for which FDA has regulatory responsibility, collecting samples for analysis, and 

preparing reports. These establishments include sponsors, clinical investigators, institutional 

review boards, and nonclinical laboratories. OBIMO evaluates inspectional and/or analytical 

findings relative to compliance and recommends appropriate follow-up. OBIMO is responsible 

for preparing and providing evidence of investigational findings. OBIMO provides dedicated 

inspectional and investigational support to Headquarters and other divisions, as needed.

OBIMO advises ORA and other centers on emerging inspectional, scientific, and regulatory 
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issues related to FDA regulated products. Additionally, OBIMO provides counsel and training 

regarding inspectional techniques and technical developments to other Federal agencies and to 

foreign counterpart agencies and to industry, as appropriate. 

Duties/Responsibilities

The Investigator II 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. 
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• 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.

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.

• Employment is subject to the successful completion of a background investigation, 

verification of qualifications, completion of onboarding forms, submission of required 

documents, and any other job-related requirement before or after appointment.

• Applicants must meet all qualification requirements by the closing date of this 

announcement.

• Direct Deposit: You will be required to have all federal salary payments electronically 

deposited into a bank account with a financial institution of your choice.

• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will 

be processed through e-Verify to determine your employment eligibility. If a discrepancy 

arises, you must take affirmative steps to resolve the matter.

• Males born after December 31, 1959, must be registered with the Selective Service.

• One-year probationary period may be required. 

• Financial Disclosure may be required.

• Ethics Clearance may be required. 

• Background Investigation/Security Clearance is required. All employees must pass a security 

investigation. Failing to pass the background check may be grounds for removal or legal 

action. If hired, you may be subject to additional investigations at a later time. 

Qualifications

To be placed into a Title 21 position, candidates must meet the following criteria:
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1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Title 21 appointments. The FDA OTS will 

use the basic requirements defined in the Title 21 Qualification Standards as a 

baseline for comparing experience levels and other candidate attributes for 

relevant positions.

b. Outstanding candidates can be defined by existing outstanding work experience, 

outstanding performance rating, or both.

To qualify for this Title 21 position, the candidate(s) must meet the following required

qualifications. Please note: Additional education and experience listed that is not indicated as 

required is preferable and desired. Candidates who do not meet the “desired” criteria will not be 

excluded from consideration for this position. 

Education/Experience Requirements: Candidate must meet the following requirements:

Education: A bachelor’s degree or higher in quality assurance/management, data 

science, statistics, computer forensics, epidemiology, pharmacy, public health, 

engineering, food science, law or regulations, or related healthcare or science field. The 

degree must be from an accredited program or institution.

OR

Experience: Comparable experience with FDA, a state or federal partner agency, or in an 

FDA-regulated industry or organization providing investigative or compliance services to 

an FDA-regulated industry, focused on evaluating or ensuring compliance with FDA or 

related public health laws and regulations. To qualify for Band A with no degree, you 

must have at least 4 years of comparable experience. To qualify for Band B with no 

degree, you must have at least 5 years of comparable experience.

Desired Education: Advanced Degree

Desired Professional Experience: 

• Knowledge and skill in applying a wide range of complex professional theories, concepts, 

principles, standards, and methods to determine, execute, and explain actions that 

modify standard practices, equipment, devices, processes, and well-known techniques 

and resolve a wide variety of complications and constraints contained in traditional 

projects. 

• Skill to adapt precedents and existing strategies which allow occupational projects to 

meet unusual needs or demands and serves as a principal contributor for the assigned 

specialty areas on team-based projects. 
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• Ability to coordinate a team project by providing technical oversight and direction for a 

variety of principal team members representing related professional disciplines, and 

evaluates and presents plans, designs, reports, and correspondence concerning projects 

and product issues. 

• Knowledge of and skill in selecting, adapting, and applying investigative methods and 

negotiating techniques to conduct complete and professional inspections and 

investigations, persuade reluctant persons and officials to provide information or access 

to information, and persuade industry representatives to agree to terms needed to 

achieve compliance. 

• Skill in planning and carrying out assignments, resolving most conflicts that arise, 

coordinating the work with others as necessary, and interpreting policy on own initiative 

in terms of established objectives. In some assignments, the employee also determines 

the approach to be taken and the methodology to be used. The employee keeps the 

supervisor informed of progress and potentially controversial matters. 

• Ability to apply judgment in interpreting and adapting guidelines, such as agency 

policies, regulations, precedents, and work directions for application to specific cases or 

problems. The employee analyzes results and recommends changes. Skilled in making 

decisions to assess unusual circumstances, variations in approach, and incomplete or 

conflicting data. 

Additional Requirements of this Position: 

• Candidates for this position must complete a statement regarding their physical ability 

and may be required to undergo physical examination because the position requires: 

o the need to work long and unscheduled hours. 

o exposure to all kinds and extremes of weather and noise. 

o the need to lift heavy objectives up to 50 pounds, walk, bend, stand, stoop, 

kneel, and climb. 

o the need to meet the vision, hearing, and olfactory requirements necessary to 

perform the work of this position. 

• Travel approximately 50 percent of the time, which will often require the incumbent to 

be away from the duty station for up to two to three weeks at a time. 

• The work involves regular and reoccurring exposure to moderate risks, discomforts, and 

unpleasantness such as: 

o contagious diseases 

o infectious materials, or toxic or irritating chemicals 

o carcinogenic materials 

o noxious fumes 

o flammable liquids 

o radiation, and/or 

o potentially pathogenic bacteria. 

• Special safety precautions such as protective clothing and equipment may be necessary. 
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• While some work is performed in an adequately lighted and climate-controlled office, 

onsite investigations and inspections may involve exposure to moderate risks or 

discomforts such as high levels of noise, dust, moving parts of machinery, irritant fumes, 

etc. Protective clothing and gear, and observance of safety precautions are required. 

• Inspection and sample collection duties are performed either inside buildings and other 

structures, outdoors, or both depending on the type and location of the facility. 

Consequently, employees are exposed to a variety of environmental conditions 

including extremes of heat, cold or humidity; excessive noise; excessive dust; uneven 

surfaces and slippery floors; and extremely adverse conditions during natural and other 

disasters such as floods, fires, hurricanes, etc. During these periods, employees must eat 

and sleep in primitive conditions with little or no privacy. The incumbent must travel 

into and work in areas that have been the subject of violence and that are otherwise 

considered unsafe. 

• This position requires the incumbent to possess a valid Driver's License to drive a 

government/privately owned motor vehicle. 

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often 

have very specific educational requirements. A transcript is required to verify educational 

achievement. Pay careful attention to the Qualifications and Education sections to identify 

vacancies where a transcript is required. Even if you hold a similar position or are a current FDA 

employee, you are not exempt from transcript requirements.

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities 

to meet the qualification requirements, you must show that the education credentials have 

been evaluated by a private organization that specializes in interpretation of foreign education 

programs and such education has been deemed equivalent to that gained in an accredited U.S. 

education program; or full credit has been given for the courses at a U.S. accredited college or 

university. For more information about this requirement, please visit the U.S. Department of 

Education website for Foreign Education Evaluation. 

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: If not previously completed, a 

background security investigation will be required for all appointees. Appointment will be

subject to the applicant’s successful completion of a background security investigation and 

favorable adjudication. Failure to successfully meet these requirements may be grounds for

appropriate personnel action. In addition, if hired, a background security investigation or 

supplemental investigation may be required later. 

Ethics Clearance Requirements

This position may require 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 
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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. 

Equal Employment Opportunity 

The United States Government does not discriminate in employment on the basis of race, color, 

religion, sex (including pregnancy and gender identity), national origin, political affiliation, 

sexual orientation, marital status, disability, genetic information, age, membership in an 

employee organization, retaliation, parental status, military service, or other non-merit factor.

Equal Employment Opportunity (EEO) for federal employees & job applicants

Reasonable Accommodation

Federal agencies must provide reasonable accommodation to applicants with disabilities where 

appropriate. Applicants requiring reasonable accommodation for any part of the application 

process should follow the instructions in the job opportunity announcement. For any part of 

the remaining hiring process, applicants should contact the hiring agency directly. 

Determinations on requests for reasonable accommodation will be made on a case-by-case 

basis. A reasonable accommodation is any change to a job, the work environment, or the way 

things are usually done that enables an individual with a disability to apply for a job, perform 

job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal 

agencies must provide reasonable accommodations when: An applicant with a disability needs 

accommodation to have an equal opportunity to apply for a job. An employee with a disability 

needs accommodation to perform the essential job duties or to gain access to the workplace.

An employee with a disability needs accommodation to receive equal access to benefits, such 

as details, training, and office-sponsored events. You can request reasonable accommodation 

at any time during the application or hiring process or while on the job. Requests are 

considered on a case-by-case basis. Learn more about disability employment and reasonable 

accommodations or how to contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility 

Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of 

new hires and the validity of their Social Security numbers.

Additional Information

Incentives: Incentives may be authorized; however, this is contingent upon funds availability. If 

authorized, certain incentives will require you to sign a service agreement to remain in the 

Federal government for a period of up to 3 years. 

Note: This statement does not imply nor guarantee an incentive will be offered and paid. 

Incentives include the following: recruitment, relocation, student loan repayment (for 

government employees only), PCS and creditable service for annual leave for prior non-federal 

work experience or prior uniformed military service, etc.
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How to Apply

Applications will be accepted from all qualified applicants. Please send letter of interest 

addressing your experience in the major duties and responsibilities of the position and 

preferred location(s), detailed current resume, SF-50 (redacted for SSN and birth year, for 

federal employees only), and college transcript(s) (with foreign credentials evaluation, if 

applicable) to the ORA Executive Recruitment and Scientific Staffing Committee, 

oraexecutiveandscientificrecruitment@fda.hhs.gov. Applications will be accepted through July 

10, 2024. Applicants must reference: 4-INV II-OBIMO-A-name of preferred location(s) in the 

email subject line.

Announcement Contact

For questions regarding this Title 21 position, please contact 

oraexecutiveandscientificrecruitment@fda.hhs.gov. 

The Department of Health and Human Services is an equal opportunity employer with a smoke 

free environment.

FDA is an equal opportunity employer.