Katherine (Katie) Norris has more than fifteen years of experience in corporate governance and compliance in the pharmaceutical, medical device, over-the-counter consumer products, and cosmetics industries. She has focused primarily on support during investigation and resolution of government investigations and compliance with enforcement actions. Her experience includes the development, execution, and management of compliance programs intended to fulfill the obligations of two corporate integrity agreements, a pretrial diversion agreement, and a non-prosecution agreement.

Ms. Norris has performed substantial internal investigations and supported extensive federal investigations with the US Department of Justice, Health and Human Services Office of Inspector General, Securities and Exchange Commission, Federal Trade Commission, Department of Education, and National Institutes of Health. She has also advised with the remediation of warning letters and 483 observations issued by the Food and Drug Administration. She is a seasoned manager of Open Payments and state physician payment disclosure obligations.

Ms. Norris supports the management of internal and external investigations and attendant outcomes (including CIAs); remediation of compliance concerns relating to promotional, quality systems, post-market surveillance, and clinical trials activities; and operational aspects of compliance program development, management, and oversight, including comprehensive compliance program design, implementation, and evaluation measures. She also advises clients on risk analyses, disclosure programs, auditing and monitoring, promotional copy review, and compliance with Open Payments and international transparency reporting obligations.

Education

University of Tennessee-Knoxville
Master of Public Administration (summa cum laude)
Concentration: Public Policy and Law

University of Alabama, Tuscaloosa
BA, Telecommunications (magna cum laude)
Minors: Philosophy, Psychology

RAC Course

Employment History

NSF Health Sciences
Senior Director, Compliance and Integrity programs
2013-2014

The Spectranetics Corporation
Director, Corporate Compliance
2009 - 2013

King Pharmaceuticals, Inc.
Manager, Corporate Compliance
2002-2005; 2007-2009 

Baker, Donelson, Bearman, Caldwell & Berkowitz, P.C.
Corporate Paralegal
2006 - 2007

Professional Affiliations

Alumni Advisory Board, Howard Baker Center for Public Policy, University of Tennessee-Knoxville

Society of Corporate Compliance and Ethics

US Attorney's Office Healthcare Fraud Working Group (Eastern District of Tennessee)

BRG Women's Leadership Committee

Community/Civic Activities

US Army Family Readiness Group

US Army Family Care Team