Investigator (Consumer Safety Officer)

***Hiring in Multiple Locations***

 Alameda, CA; San Jose, CA; Fresno, CA; Stockton, CA; Sacramento, CA; Irvine, CA; San Diego, CA; Ontario, CA; Long Beach, CA; Woodland Hills, CA

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. 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 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/fda-organization/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 FDA-regulated 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 Consumer Safety Officer Investigator (CSOI) 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 CSOI 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 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

How to Apply: Applications will be accepted from all qualified internal and external 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 December 31, 2023. Applicants must reference: 4-CSOI-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.