Careers Over Coffee is a new initiative coming out of FDLI’s Student Membership Program that offers student members the exclusive opportunity to engage in facilitated virtual discussions over coffee about different career paths in the food and drug profession. This month Careers Over Coffee will be focusing on the hiring process and will feature experienced individuals involved in the hiring process for the food and drug law profession. It is more important than ever to connect and share experiences which is why Careers Over Coffee will provide a virtual space for students to ask questions about their career path and network with each other. This student member-only benefit provides a chance to closely learn from and network with experienced professionals in the field.
Please only sign up for one discussion as they will take place at the same time.
Facilitators and Interest Areas
John (Barr) Weiner, Associate Director for Policy FDA-OC
Government, Opportunities after FDA
Colleen Heisey, Partner Jones Day
Private Practice Hiring, Large Firms vs Small Firms
Suzan Onel, Partner Kleinfeld, Kaplan & Becker, LLP
Law Firm Hiring, Small Firms vs Large Firms, Finding FDA related options after law school
Cynthia Schnedar, Principal Greenleaf Health, Inc.
Consulting, Government Hiring, Department of Justice
JOHN (BARR) WEINER is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a BA from Princeton University and a JD with honors from the Columbia University School of Law.
COLLEEN HEISEY is a Life Sciences Partner in Jones Day’s Washington office. Colleen helps clients understand and navigate the regulatory paradigms related to FDA-regulated therapeutic products, deploying her skills in traditional regulatory and compliance counseling as well as in transactions and litigation. Colleen graduated with honors from The George Washington University Law School, and leverages her other degrees in practice (BS in Biology with dual minors in Chemistry and Environmental Science, Lycoming College; MPH, Johns Hopkins University). She is admitted to practice in California and DC, and before the US District Court for DC and the US Supreme Court.
SUZAN ONEL is a partner at the Washington, DC law firm, Kleinfeld, Kaplan & Becker, LLP (KKB) and a recognized expert in FDA law. Ms. Onel has advised medical device, pharmaceutical, food, supplement, and cosmetic clients on FDA-related legal and regulatory issues since 1990. She has extensive experience counseling international and domestic manufacturers, distributors, and researchers on market entry strategies, premarket submissions (510(k)s, PMAs, IDEs, De Novo submissions), labeling and promotional activities, regulatory compliance, adverse event reporting, recalls and field corrections, and enforcement defense. Ms. Onel also advises on the development of corporate compliance programs and regulatory strategy. Her transactional work includes conducting regulatory due diligence for life science companies and investors, drafting supplier contracts and clinical research agreements, and conducting executive training sessions. Prior to joining KKB in 2016, Ms. Onel was Chair of the FDA Practice at a global law firm. She is a frequent and sought-after author and lecturer on FDA-related topics and was recently invited by the US State Department to be the keynote speaker at a government-sponsored conference in Honduras focused on trade facilitation and best practices to improve entry of food, drugs, and medical devices in Central America. Ms. Onel is a member of numerous professional organizations and is past Chair of the Medical Device Committee of FDLI; past co-Chair of the editorial board of FDLI’s Update Magazine; and past Chair of the ABA’s Food, Cosmetics and Nutraceuticals Committee within the Section of Science & Technology Law. She received her law degree from the University of Virginia School of Law, where she was an editor of the Virginia Environmental Law Journal, and she received her BA with honors from the University of Pennsylvania with a double major in Biological Basis of Behavior (neurobiology track) and European intellectual history.
CYNTHIA SCHNEDAR, Executive VP of Regulatory compliance at Greenleaf Health, provides strategic advice to clients in the life sciences industry. She was formerly Director of the Office of Compliance for FDA CDER, where she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Cynthia previously served at the Department of Justice (DOJ) as Acting Inspector General and in other leadership positions focused on compliance and enforcement issues. Cynthia also served as a prosecutor and a civil trial attorney for DOJ. Cynthia clerked for a judge on the US Court of Appeals for the Ninth Circuit and worked as a television reporter for local stations in New Mexico and Texas. Cynthia earned a BA with Distinction from the University of New Mexico and a JD with Honors from the University of Texas School of Law.March 16, 2022
1:00-2:00 PM ET
Registration is open to FDLI student members only and is first come, first served.
This is a complimentary virtual event.
Please only sign up for one discussion as they will take place at the same time.
For questions, please contact Tess Garraty.
