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:
ORAInvestigatorHiring@fda.hhs.gov. 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
ORAInvestigatorHiring@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.
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Seniority level
Entry level -
Employment type
Full-time -
Job function
Research -
Industries
Government Administration
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