Sharon O. Small is Counsel to Porzio, Bromberg & Newman and a member of the firm’s Life Sciences Compliance and Regulatory Counseling Department. She has extensive experience handling regulatory issues to ensure compliance with FDA and Anti-kickback regulations and the PhRMA Code and AdvaMed Code on behalf of Fortune 500 and small pharmaceutical/biotech companies.
With her background as in-house counsel in the pharmaceutical/healthcare industry Sharon Small is knowledgeable regarding the business challenges faced by members of corporate legal and compliance departments. As assistant counsel for Merck, Ms. Small provided legal advice and support on a worldwide basis to the Manufacturing Division (MMD) and Business Affairs Department on the manufacturing aspects of a wide range of business development transactions including in-licensing, out licensing, distribution, joint venture, divestiture, co-marketing, co-promotional, and commercial collaboration arrangements. She also supported the Quality Operations Department with respect to regulatory compliance issues affecting all manufacturing sites, including Good Manufacturing Practices and quality issues. Ms. Small also drafted and reviewed quality agreements and communications with regulatory agencies (including the FDA) including field alerts, biological product deviation reports and product recalls.
Drug Information Association, Washington, DC, Marketing Pharmaceuticals Training Course, 2014
Seton Hall Law School, Newark, NJ, Health Care Compliance Certification, 2013
University of Pennsylvania Law School, Philadelphia, PA, J.D., 1996
Fairleigh Dickinson University, Teaneck, NJ, B.Sc. Business Management, magna cum laude, 1993
100 Southgate Parkway
Morristown, NJ 07962-1997