Berkeley Research Group, LLC (BRG) is a global consulting firm that helps leading organizations advance in three key areas: disputes and investigations, corporate finance, and strategy and operations. Headquartered in California with offices around the world, BRG is an integrated group of experts, industry leaders, academics, data scientists, and professionals working beyond borders and disciplines. BRG has in-depth experience across a wide range of industries and markets, from construction and energy to technology and life sciences.
BRG’s Corporate Compliance and Risk Management experts have extensive pharmaceutical and medical device industry expertise and advise companies on developing and implementing effective corporate compliance and risk management programs. Our professionals have firsthand experience in C-suite corporate compliance, government enforcement, and advanced transactional data analysis; therefore, they have a greater understanding of the operational, technical, and legal challenges that compliance officers must address. BRG experts leverage this industry and enforcement knowledge, and leading compliance best practices to provide innovative, data-driven, cost-effective, and practical solutions to enhance operational efficiency, inform business decision making, and proactively address and remediate key compliance risks.
Ms. Norris brings 17 years of compliance experience to support life sciences companies in a broad range of strategic and operational compliance objectives. As an industry professional, Ms. Norris has developed and overseen all aspects of compliance programs, including CIA implementation; HCP engagement and Fair Market Value determination; auditing and monitoring; interactions and engagements with health care professionals; strategic marketing and sales initiatives; transparency reporting; class-wide REMS compliance for controlled substances; and clinical, R&D and post-market surveillance. She has managed global FCPA/ABAC programs as well as a complex OFAC/ITAR/EAR compliance program for the manufacture, sale and distribution of chemical weapons antidotes sold exclusively to US and foreign militaries. Ms. Norris has also performed substantial internal investigations and supported extensive federal investigations with the U.S. DOJ, HHS OIG, and SEC, among others.
Craig Clesson is a compliance consultant with nearly 14 years’ experience in the pharmaceutical and biotechnology industries. Craig was most recently the Vice President, Ethics and Compliance Officer at Aegerion Pharmaceuticals, a small pharmaceutical company based in the Boston area focusing on two ultra-rare diseases. Prior to Aegerion, Craig was a Director of Compliance at Amgen. At Amgen, Craig’s responsibilities included collaborating with management to develop and update rules of engagement for interactions and arrangements with U.S. payors, integrated health networks, Medicare advisory committees, quality measure development organizations, and similar entities. Prior to Amgen, Craig was Senior Counsel at King Pharmaceuticals, a mid-size pharmaceutical company that is now a subsidiary of Pfizer, Inc. At King, Craig’s responsibilities included supporting the compliance organization, and advising the commercial and medical leadership teams on activities related to marketed and pipeline products in the cardiovascular, surgical, and pain management franchises.