The U.S. Food and Drug Administration (FDA) stands as a cornerstone in the biotech industry, particularly as we navigate into 2024, a year poised for significant biopharmaceutical advancements following a year marked by an uptick in FDA approvals. The FDA is an impressive organization with more than 19,000 employees, according to Medical Marketing and Media. In this article, we focus on the position of investigators at the FDA.
To get a better look into what it means to build a career as an investigator at the FDA, we reached out to someone who has gone through the process, Gene Gunn. Gunn is a Commissioned Officer in the U.S. Public Health Service, where he has been assigned to work as an FDA Investigator for the past 15 years. For the past five years, he has been a member of the Foreign Cadre in the Office of Bioresearch Monitoring (OBIMO), where he is responsible for conducting inspections of foreign clinical research investigators/clinical study sites, study sponsors, and contract research organizations (CROs).
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What is an FDA investigator?
An FDA investigator is responsible for ensuring the safety, quality, and effectiveness of consumer products like food, drugs, veterinary medications, medical devices, vaccines, and cosmetics. Unlike FDA inspectors who perform routine checks, investigators respond to problems such as outbreaks of illness, injury reports, and consumer complaints. They also play a crucial role in gathering evidence for prosecuting crimes related to product fraud and tampering.
The Office of Regulatory Affairs (ORA) is the FDA branch where many investigators are employed, conducting inspections and overseeing the enforcement of FDA regulations. ORA is instrumental in ensuring the integrity of the products entering the U.S. market and plays a key role in public health protection.
What does an FDA investigator do?
When we asked Gunn to tell us about what his week looked like, he answered that a week would be too narrow to get an idea of what his job looks like.
“When doing domestic work, my usual schedule is spending a week handling administrative tasks and preparing for my next inspection. The following week would include conducting the inspection of clinical investigators, study sponsors, biopharmaceutical testing and manufacturing facilities, or Institutional Review Boards. Inspections where violative conditions are found can go on for longer than a week. Once the inspection is completed the next week is spent writing up the report of the inspection,” explained Gunn.
Being on the BIMO International Inspection Cadre, Gunn generally goes out on foreign assignments for three weeks, comes back to write those reports, and prepares for his next trip over the course of five to six weeks before heading out again.
How to get into the FDA?
The Cures Act has set the rules to apply for entry-level positions at the FDA, and it is easy for an applicant to know what to expect. Although the process is straightforward, a strong scientific background is key in succeeding your job search at the FDA.
The Cures Act
The 21st Century Cures Act, enacted on December 13, 2016, significantly impacted the FDA’s hiring capabilities. Section 3072 of the Act allows the Commissioner of Food and Drugs the authority to appoint candidates and set their pay for roles that support the development, review, and regulation of medical products, which was further expanded to include positions related to the regulation of food and cosmetics.
The FDA has initiated a new pay system to compete more effectively for employees in high-demand fields. This system is partly a response to the challenge the FDA faced in hiring specialists in areas like biostatistics, genetics, biomedical engineering, and health informatics, where there is a noticeable pay gap between government positions and the private sector. This system is structured into nine pay bands from A to I, designed to offer more competitive salaries than those traditionally available through federal government pay scales.
The introduction of these pay bands and the streamlined hiring process under the Cures Act aim to fill mission-critical positions that have historically been challenging to staff.
The application process
The process of getting into the FDA starts by applying for an investigator position. The governmental FDA website keeps up to date with the currently available positions. Job announcements can also be found on the USAJobs website.
The first step of the application process is similar to what you would expect in any entity and requires the submission of several documents to the ORA Executive Recruitment and Scientific Staffing Committee:
- A letter of interest including the states and cities the applicant is interested in working in
- A resumé
- An academic transcript
- For federal employees only a standard form 50 (SF 50)
Who qualifies for an FDA investigator position?
To become an FDA Investigator or Consumer Safety Officer, one needs a strong educational foundation, typically a bachelor’s or higher degree in quality assurance, management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, biological sciences, chemistry, pharmacy, or related scientific fields. This education provides the necessary knowledge directly related to investigator work.
Since the enactment of the Cures Act, the system has changed and the academic and professional requirements for entry-level jobs evolved.
To qualify for a band A position, a candidate must have either:
- A bachelor’s degree and 2 years of comparable experience
- A master’s degree and 1 year of comparable experience
- A Ph.D. with no experience
- Without a bachelor’s degree, a candidate must have 4 years of comparable experience
To qualify for a Band B position, a candidate must have:
- A bachelor’s degree and 3 years of comparable experience
- A master’s degree and 2 years of comparable experience
- A Ph.D. and 1 year of experience
- Without a bachelor’s degree, a candidate must have 5 years of comparable experience
Gunn defined comparable experience as “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 an investigator position at the FDA, it is also required to be a U.S. citizen and to go through a background check.
Once you receive the good news that you are being hired to work for the FDA, you still have a choice to make. You can work as a civil service employee or apply for a commission in the U.S. Public Health Services (USPHS). Both alternatives offer different perks but Gunn reminded us that working at the FDA as a Commissioned Officer in the USPHS requires the daily wear of the uniform, the ability to meet fitness standards, and being on-call for deployment during national or state-level emergencies, such as natural disasters or public health emergencies.
Advice from an FDA investigator to a potential applicant
“The investigator positions require up to 50% travel, including annual international travel obligations, which can be challenging for some people but I have found this position to be very rewarding as someone who craves novelty and challenges.”
Gunn recommends this position to flexible people, who have a desire to travel and are intrigued by novelty as this position will have you learning about the testing and manufacturing of innovative drugs and devices weekly. This is one of the challenging aspects of the job; it requires a lot of training to learn how to appropriately inspect firms and how to document deficiencies.
The inspection is a high-responsibility task as the investigators are faced with high-level executives of the firms they are inspecting, and it is the consumer protection against adulterated products that is at stake. But the reward is getting to meet new people and discover new countries as your career progresses.
Gunn said the FDA workforce is very diverse and there are a lot of opportunities for people with scientific backgrounds.
“If travel is not your thing, do not be discouraged as there are Reviewer positions in Washington that do not require the travel that the Investigator position does. These positions have different requirements as the great majority of the Reviewers are pharmacists, doctors, and Ph.D. level scientists.”