Katherine C. Norris
MPA, DIRECTOR, LIFE SCIENCES – GOVERNANCE, RISK MANAGEMENT AND COMPLIANCE, GUIDEHOUSE
Katie Norris has 19 years of experience in corporate governance, risk and compliance focused predominantly in the life sciences and healthcare industries, including 12 years as an industry professional. Ms. Norris regularly supports counsel to assess the effectiveness of corporate compliance programs in privileged consulting matters coinciding with government investigations. She has supported clients in numerous high-profile matters, including the prosecution of individuals, led by the U.S. DOJ, HHS OIG, SEC, FDA, CMS, and EPA, among others.
Ms. Norris also works directly with companies under enforcement decrees on a wide variety of compliance-related matters to ensure successful performance under CIA/DPA. She has developed and overseen all aspects of compliance and risk management programs at pharmaceutical and medical device companies, including: Board of Directors communications and certifications; CIA implementation; fair market value assessments; Risk Assessment and Mitigation Programs; auditing and monitoring; interactions and engagements with health care professionals; strategic marketing and sales initiatives involving Class II pharmaceuticals and Class III medical devices; transparency reporting; class-wide REMS compliance for controlled substances; and clinical, R&D and post-market surveillance. She has also 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. She has performed numerous complex compliance investigations and led restructuring initiatives on topics ranging from third party funding to free drug and patient assistance programs and interactions with specialty pharmacies.