JOHN E. NIZNIK is the Associate Director of Regulatory and Compliance Services for Porzio Life Sciences, LLC. Mr. Niznik coordinates the maintenance of the organization’s Distribution: Trade & Sample Databases and its Pedigree Requirements Compliance Module. In his role, Mr. Niznik oversees the monitoring of the state and federal statutes, regulations and legislation affecting life sciences manufacturers and distributors.
Mr. Niznik is well versed in sampling issues, including licensing and distribution requirements, storage and handling, record keeping, written policies and procedures, and theft and loss reporting. Additionally, he has extensive experience in the area of mid-level practitioners, including the management of projects involving the creation of customer-specific business rules related to mid-level sampling.
Mr. Niznik is involved in the maintenance of the federal portion of the Porzio Compliance Digest, including databases related to PDMA Inspections, OPDP Untitled and Warning Letters, and Government Prosecutions. In this role, Mr. Niznik tracks the variety of ways that federal agencies monitor the activities of life sciences companies.
Mr. Niznik is co-author of two Thought Leadership and Marketing Compliance articles, 2001’s “Navigating Loss Reporting: How to Meet FDA and State Reporting Requirements,” and 2007’s “The Shifting Sands of Wholesale Distribution. He received a Bachelor of Arts from Widener University and a Certificate in Paralegal Studies from Fairleigh Dickinson University.