Investigator II

**MULTIPLE VACANCIES IN MULTIPLE LOCATIONS**

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; Winchester, 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

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. Additional information on the 21st Century Cures Act can be

found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

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

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.

• 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. Please send letter of interest

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

preferred location(s), detailed current resume, and college transcript(s) (with foreign

credentials evaluation, if applicable) to ORA Investigator Hiring at:

[email protected]. Applications will be accepted through July 10, 2024.

Applicants must reference: 8-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

[email protected].

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

free environment.

FDA is an equal opportunity employer.