Mark Scallon

Principal at Baker Tilly

Speaker

Mark has more than 20 years of experience working with clients in the life sciences industry to transform their compliance functions. He has particular knowledge in compliance program development, process design, compliance auditing and monitoring, risk assessments, global spend transparency reporting, global investigations, privacy, pricing, and anti-bribery and corruption. Over the last 20 years, Mark has assisted life science organizations with identifying existing and emerging compliance risks to develop practical solutions aligning company policies and procedures with industry practices, guidelines, regulations and laws.

Specific experience:

• Executed global spend transparency projects for more than 50 companies, including assessment, strategic planning and technology implementations
• Executed a third-party distributor audit program for a midsized medical device company focused on identifying Foreign Corrupt Practice Act (FCPA) and Anti-Bribery/Anti-Corruption (ABAC) risks
• Conducted, under attorney-client privilege, pre-independent review organization (IRO) audits across multiple risk areas for a large, global biotech company
• Developed compliance program framework for a growing compliance function at a mid-size biotherapeutic company that was looking to expand globally
• Completed fair market value (FMV) assessment for healthcare professionals in the U.S. and globally, resulting in the provision of FMV rates and documented methodologies across a number of physician specialties and geographies
• Completed General Data Privacy Regulation (GDPR) and California privacy assessment and implementation projects for three biotech companies
• Executed multiple audits and process assessments related to external funding requests, including medical education grants, charitable contributions/foundations, sponsorships, etc.• Conducted HUB audits to identify key areas of risk and recommended corrective actions to mitigate exposure
• Designed and implemented a global monitoring program for a large biotech company, which included monitoring of email communications, speaker programs, advisory boards and CME events
• Conducted compliance risk assessments through the analysis of compliance and magnitude parameters