Craig B. Bleifer
Principal, Craig B. Bleifer, LLC
Craig Bleifer, JD, is the principal of Craig B. Bleifer, LLC, a law and consulting practice focused on advising and counseling clients on health care industry topics. He has also been appointed as a Consultant to Akin, Gump Strauss, Hauer & Feld LLP to support clients in their national health care practice.
Professor Bleifer is an experienced health care executive, having served as general counsel for Novo Nordisk (2018-2020) and for Daiichi Sankyo (2000-2018). He has been the leader of diverse corporate functions, including legal affairs, litigation, compliance and audit, intellectual property, regulatory affairs, government affairs and public policy, and communications and corporate social responsibility.
As a practicing corporate and health care attorney for almost 30 years, he advises clients on legal, compliance, policy, and regulatory matters relating to health care products and businesses along the full spectrum from discovery through commercialization. He is well versed in the process and the inner workings of the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services. Professor Bleifer also has years of experience with critical health care compliance issues and counsels clients on relevant Department of Justice and Office of Inspector General guidance and enforcement practices and industry codes of conduct to craft compliance charters, policies, board and executive fiduciary training, employee role-based training, the creation of effective monitoring and auditing programs, instituting a Risk Assessment and Management Process (RAMP), and conducts internal compliance investigations.
A leader in the health care industry, Professor Bleifer formerly served as a chair of the Pharmaceutical Research and Manufacturers of America’s Law Section Executive Committee and as a chair and board member of the Healthcare Institute of New Jersey. He was awarded General Counsel of the Year by NJBIZ and was awarded In-House Legal Department of the Year by the New Jersey Law Journal. Professor Bleifer is a regular author of articles on health care issues and a speaker at industry-wide events.
He is a graduate of the New York University School of Law and holds a BA from Vassar College in Sociology.