Melissa Christoph

About Melissa Christoph

Accomplished Corporate legal executive, Compliance Officer, Corporate Secretary, and…

Experience

1. Legal, Regulatory, Healthcare Compliance, and Data Privacy Consultant

   Mayne Pharma

   Mar 2024 — Present · Raleigh, NC, US

   Advised on FDA, DOE, Corporate Transparency, Federal Acquisition regulatory and healthcare compliance matters.• Prepared FDA and other regulatory approval strategic plans, advised on manufacture, sale, and distribution requirements, & drafted regulatory submissions.• Created pharmaceutical manufacturer government contracting and price reporting regulatory tracking tools, templates, policies, and procedures. • Advised specialty pharmacy infusion centers on compliance with fraud and abuse regulations, anti-kickback statutes, data privacy, and other healthcare compliance requirements.• Authored healthcare compliance program charter, policies, and procedures.• Provided FDA promotional Review Committee support.• Established pharmaceutical manufacturer with government entities for supply contracts, regulatory inspections, and FDA audits.• Advised clients on practical, efficient, & cost-effective implementation of regulatory changes.• Prepared and negotiated federal grant, supply, and loan applications, ensuring regulatory compliance.• Developed and implemented comprehensive healthcare compliance programs.• Conducted internal audits and risk assessments, collaborated with leadership on mitigation plans, and monitored employee activities and plan implementation progress.• Drafted policies and procedures for healthcare provider interactions, antitrust and competition, Sunshine and transparency reporting, & government price reporting.• Prepared and conducted healthcare compliance training for employees.• Provided expert guidance on day-to-day compliance matters.• Advised on U.S, U.K, and E.U. data privacy regulations, including GDPR and CCPA compliance.• Developed robust data privacy policies and implemented state-specific compliance measures.• Prepared Privacy Impact Assessment tools and conducted assessments for new and established data privacy programs.• Managed data security breach notifications and ensured vendor and HIPAA compliance.

Education

• University of Delaware

  Bachelors Degree with Distinction

  2000 — 2005

• Rutgers, The State University of New Jersey-Camden

  Doctor of Law - JD

  2006 — 2009

• Seton Hall University School of Law

  Certification Program

  2015 — 2015

• Food & Drug Law Institute

  Certification in FDA Drug Law and Promotion

  2018

• Seton Hall University School of Law

  Data Privacy and Security Compliance Certification

  2021