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FROM THE FELLOWS COMMITTEE
Careers in Regulatory Affairs
Regulatory professionals play critical roles in the health-care product lifecycle and protect public health by influencing the safety and efficacy of pharmaceuticals, medical devices, cosmetics, and complementary medicines. On February 14, 2012, experts spoke to NIH trainees about career opportunities in regulatory affairs.
Janice Chappell, a senior director of regulatory affairs at Aeras (Rockville, Md.), outlined the landscape of the field and the skills important for success. David Debany, a senior associate in regulatory affairs at Millennium Pharmaceuticals (Boston office), described the role of regulatory publishers and business analysts. Jason Urban, a scientist at FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance (Silver Spring, Md.), shared insights into the process of transitioning from bench science to regulatory affairs. Nicole Gormley, a medical officer at the FDA’s CDER Office of Oncology Drug Products, explained how her experience as an NIH clinical fellow prepared her as a clinical reviewer of investigational new drug applications. Elizabeth Glaze, a regulatory specialist in NIAID’s Division of Microbiology and Infectious Diseases, discussed the roles toxicologists play in designing preclinical protocols and reviewing data in clinical trials.
There is no typical career path and no special degree needed. Regulatory affairs professionals come from the medical, research, pharmaceutical, project management, and manufacturing fields and can specialize in drugs, biologics, devices, or product development in clinical trials. They need to be excellent communicators, open-minded, active listeners with problem-solving abilities, and adaptable.
Attendees were urged to use the Regulatory Affairs Professionals Society, which offers courses, meetings, and resources; and LinkedIn to develop networks, conduct informational interviews, and determine the specialties and organizations to target.
For information on past events, visit https://www.training.nih.gov/FelCom/CareerDevelopment. To see a videocast of the February 14 event, visit https://www.training.nih.gov/events/view/_2/776/Careers_in_Regulatory_Affairs.
FROM THE OFFICE OF INTRAMURAL TRAINING AND EDUCATION
The New NIH Academy, Apply Now
Minorities get sick sooner, have more severe illnesses, and die sooner than whites, according to health-disparities expert David Williams at Harvard (Boston). This much has been known for years. NIH is dedicated to eliminating these health disparities—inequalities among populations in rates of disease incidence, prevalence, morbidity, and mortality—through research as well as training programs such as the NIH Academy.
The NIH Academy, which was launched in 2001, trains postbaccaulaureates (postbacs)—142 so far—to do research on health disparities. The hope is that this next generation of researchers and health-care providers will understand, and play a role in eliminating, health disparities. This year, the Office of Intramural Training and Education (OITE) is launching a bigger and better NIH Academy.
The “old” academy trained 12 to 16 postbacs a year; the new one will train as many as 100. Trainees can pursue either a certificate program that carries a time commitment of 30 to 40 hours over a 10-month period, or a more intensive fellows program with a time commitment of about 100 hours over 10 months. The certificate program is for those who may not have had previous exposure to the health-disparities field. The fellows program is an in-depth experience for those interested in careers that incorporate the elimination of health disparities.
Both programs will feature the theme of health disparities in vulnerable populations and will include journal clubs, seminars, expert-led discussions, community outreach, and career-development workshops. OITE’s goal is to broaden trainees’ understanding of the various determinants of health and to emphasize that eliminating health disparities is a critical component of improving the health of all Americans.
An added benefit of the new program is that for the first time all current NIH postbacs are eligible to participate, including trainees on satellite campuses. Letters of interest in the NIH Academy, emphasizing a strong desire to learn about health disparities, may be submitted to OITE between May 1 and August 1. Applicants will be notified of their acceptance in mid-August.
This page was last updated on Monday, May 2, 2022