Featuring: Janelle Derbis, PharmD
By: Serina Lin, PharmD Candidate c/o 2024
Janelle Derbis is a PharmD graduate of Drake University, College of Pharmacy and Health Sciences, located in Des Moines, Iowa. She is currently the Director of Regulatory Affairs at Merck & Co., Inc. She has prior extensive experience in the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research and the Office of the Commissioner.
1. What kind of experiences did you have after graduating from pharmacy school?
My first job out of pharmacy school was working as a pediatric pharmacist in a hospital in Virginia. I transitioned into a role at the FDA and worked there for 21 years. In 2021, I began my career in the pharmaceutical industry with Merck on the regulatory affairs team. It’s been almost 2 years!
2. Can you share a little bit more about your role in the FDA?
At the FDA, I liaised with health professional organizations such as the American Pharmacist Association (APhA), the American Society of Health-System Pharmacists (ASHP), the American Medical Association (AMA), and patient advocacy groups. I worked to ensure that their voice was heard within the agency. So, if a law was passed giving the FDA additional authority, we would have to implement it and oftentimes, it would have a direct impact on pharmacists, physicians, patients, etc. The FDA wants to make sure these health professional organizations and patient advocacy groups understood what was proposed and that any comments they had were listened to and addressed. In addition, I was the program director of the Advanced Pharmacy Practice Experience (APPE) program. Toward the end of my career at the FDA, I worked on issues related to the opioid epidemic.
3. Can you describe your time in the Public Health Service?
During my time in the Public Health Service, I served in a leadership role on the pharmacy professional advisory committee, where I collaborated with pharmacists across different agencies within the Department of Health & Human Services. Additionally, I was involved with outreach to pharmacy colleges to teach students about the opportunities for pharmacists within the federal government
4. What is your role at Merck & what does your typical day look like?
In my current role at Merck, I lead regulatory activities related to product shortages and deletions. I also ensure our products are compliant with the Prescription Drug User Fee Act (PDUFA).
5. What kind of skills did you bring over from the FDA to Merck?
Some of the skills that that I brought from the FDA to Merck include:
- Knowing how the legislative and policy-making process works
- Teamwork & communication- Being able to work collaboratively, even with professionals of different backgrounds
- Having an understanding of the FDA approval process
- Being able to monitor the regulatory landscape
6. What is your favorite part about your job? Challenges?
My favorite part about my job is that I am constantly surrounded by innovation, whether that be digital innovation or the next drug that’s coming up in the pipeline. One of the challenges that I face in my role is the complexities around drug shortages. It is such a big issue and is so multi-faceted. Not one solution fits all and it needs to be addressed from different angles.
7. What is some advice you can give students interested in pursuing a career in regulatory or FDA?
- Look for opportunities to get involved in student organizations because that enables networking opportunities
- Taking leadership roles in student organization
- Seek summer internships to better understand the various opportunities for pharmacists within that organization
- Talk with pharmacists you know in different fields to open your perspectives
- Your first job is not your last job
