Managing Attorney & Principal
Jamie is considered by her peers to be a life sciences legal and regulatory compliance expert as she advises companies on a variety of U.S. Food and Drug Administration (FDA) regulatory, compliance, and enforcement issues. She also provides a broad range of business advice and strategic counseling to pharmaceutical, device and biologic manufacturers. Clients turn to Jamie for guidance in connection with audits, government investigations, internal investigations, contractual arrangements and the development, implementation and review of compliance and ethics programs. Notably, corporate executives and boards of directors also seek Jamie’s counsel on matters related to developing, implementing, evaluating, and auditing internal compliance and ethics programs. As part of her regulatory practice, Jamie advises on marketing authorization issues to post-marketing compliance, lifecycle management and significant enforcement matters. She also advises clients on product recalls, marketing applications, labeling, marketing and advertising permissibility, and privacy issues. Jamie also works with clients on post-marketing obligations such as adverse event reporting and Approved Risk Evaluation and Mitigation Strategies (REMS).
Jamie’s prior legal experience includes serving as General Counsel for a U.S. pharmaceutical company that has international touch points. She was also an associate with Morgan Lewis & Bockius LLP in its Philadelphia Litigation Practice Group. While there, she represented pharmaceutical and medical device companies in complex civil litigation and government investigations involving products liability claims, state and federal false claims statutes, the Stark Law, fraud and abuse violations and state and federal anti-kickback statutes.
Jamie earned her Juris Doctorate from Rutgers University School of Law – Camden. While at Rutgers Law School, she worked as a judicial law clerk for the Honorable William C. Carpenter, Jr. of the Superior Court of Delaware, the Honorable F.J. Orlando, Jr. A.J.S.C. of the Superior Court of New Jersey, and the Honorable M. Faith Angell of the U.S. District Court for the Eastern District of Pennsylvania. Jamie earned her B.A. in Journalism from Indiana University of Pennsylvania and is admitted to practice in the state and federal court of both Pennsylvania and New Jersey. Jamie currently serves as general counsel to the PDE – the longest running Pharmaceutical Trade Association.