Sharon O. Small

Expand all

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.

Prior Relevant Experience
  • Convatec, Inc., Skillman, NJ, Contract Attorney, 2013 - 2014.
  • Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ, Contract Attorney, 2012 - 2013.
  • Merck & Co., Inc., Whitehouse Station, NJ, Assistant Counsel, 2006 - 2011.
  • Ramey & Flock P.C., Tyler, TX, Associate, 2004 - 2006.
  • AT&T Law and Government Affairs, Lavipharm Laboratories, Inc., and Convatec, a Division of Bristol-Myers Squibb, Contract Attorney, 2000 - 2003.
  • Reed Smith Shaw & McClay, Princeton, NJ, Associate, 1998 - 1999.
  • United States District Court, Eastern District of Pennsylvania, Honorable Clifford Scott Green, Law Clerk, 1996 - 1998.
Publications
  • "Spoliation and Electronic Discovery: A New Wrinkle in an Old Concept," The Business Suit, Defense Research Institute, July 2005.

Practice

Industries

Related Media

Bar Admissions

New Jersey

Education

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

 

 

Contact Address

100 Southgate Parkway

Morristown, NJ 07962-1997

Phone: 973.889.4130

Fax: 973.538.5146