Ombudsman, Office of Regulatory Affairs
Jessica Zeller, J.D., is the newest FDA ombudsmen in a position that was created for the first time in the Office of Regulatory Affairs. In this position, Jessica serves as an impartial voice to bring FDA and external parties toward a common understanding (often referring to herself as a translator). This newest position is instrumental in bridging gaps that might have existed for decades, as the Office of Regulatory Affairs houses all of the investigators across the country.
Our live interview of Jessica explored the following questions:
Can you explain the roles of the ombudsmen across the FDA, and why your role was created in ORA?
What is your reporting structure, and how is information kept confidential? (Should Industry fear retribution?)
You handle many different kinds of issues. Can you explain what impact you have in those situations? (How does industry benefit from calling you?)
Having been in industry, what do you feel prevents companies from utilizing your services?