Melissa Cox Swanson

WORK HISTORY

EDUCATION

ABOUT MELISSA COX SWANSON

Compliance Professional with 12+ years in medical device and pharmaceutical industries, Melissa is skilled in directing, developing, and maintaining effective US and global compliance programs. She is Certified in Healthcare Compliance (CHC) and has led comprehensive compliance programs and data privacy reporting in both private and public organizations, ranging from startups to global pharmaceutical companies. Melissa brings with her extensive knowledge of the complex legislation, rules, and laws governing medical device and pharmaceutical operations. By tapping into this expertise, she is able to strategically develop programs that not only comply with all applicable laws and regulations, but drive business and growth. She has applied this experience to build tailored programs from the ground up for pharma and biopharmaceutical startup, creating policies, procedures, audit and monitoring, aggregate spend systems and reporting, ethics hotlines, travel and expense systems, and robust training programs from scratch. In addition to establishing foundational compliance programs, Melissa strengthens existing programs, policies, and enterprise risk assessments by identifying and remedying gaps related to data quality, compliance regulations, enforcement actions, trends, and industry best practices. She ensures compliance with all pharmaceutical and medical device laws and regulations, Corporate Integrity Agreement (CIA) requirements, and industry standards applicable to interactions with healthcare professionals (HCP) and healthcare organizations (HCO) by manufacturers (e.g, anti-bribery/anti-corruption, fraud & abuse, anti-kickback, off-label promotion, PhRMA, AdvaMed, MedTech Europe, OIG guidelines, Data Privacy, and CMS Open Payments/Sunshine and state transparency).To ensure company-wide alignment with compliance strategy, Melissa leads cross-functional collaboration across business units, partnering with executives to ensure effective program implementation. Throughout the course of her career, Melissa has developed trainings and presentations to drive a culture of compliance and educate domestic and international employees and vendors. Melissa is enthusiastic about her work and a recognized leader among the professional compliance community. She is routinely invited to speak on a range of compliance, data privacy, and aggregate spend topics.