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Darren is a risk management professional focused on the unique challenges of the life sciences industry by leveraging a 20-year career in audit, compliance and consulting where he supported a diverse global portfolio of clients spanning all stages of maturity.
Darren leads a multidisciplinary practice supporting companies in the industry by leveraging more than 20 years of global experience in management consulting, audit and compliance. He has supported a diverse global portfolio of clients spanning all stages of maturity and industry segments. Baker Tilly’s life sciences consulting practice supports clients in balancing opportunity and risk through thoughtful insights and practical support across critical business functions including market access, compliance, commercial operations and medical affairs.
Darren’s experience includes designing, implementing and operating solutions designed to mitigate risk while aligning to performance expectations for brands. Through managing compliance operations for clients and supporting commercial and medical affairs efforts of specialty pharmaceutical companies, Darren brings a unique performance driven approach to solving the dynamic challenges of the industry.
- Managed outsourced compliance operations for clients, including policy writing, training, monitoring HCP/O engagement and materials review
- Supported several pre-commercialization specialty pharmaceutical companies to implement compliance programs covering all healthcare interactions by scientific, medical and commercial professionals
- Conducted compliance risk and needs assessment projects to establish compliance office priorities and a common risk awareness by management’s compliance committee and the board’s audit committee
- Collaborated with clients to establish key risk indicators (KRIs) to monitor compliance program effectiveness and direct compliance oversight activities, including field monitoring
- Developed a methodology for assessing fair market value of bonafide service fees paid to various third parties, including wholesalers, specialty pharmacies, GPOs, payers, etc.
- Compliance Congress for Specialty Products: Cell and Gene Therapies Learning Lab - Compliance Considerations for Highly Complex, potentially Curative Treatments
- Compliance Congress for Specialty Products: Co-Moderator - Shine a Spotlight on medical Affairs and MSL Activities
- Compliance Congress for Specialty Products: Moderator - Examine the High-Priority Risk Areas for Biotech and Specialty Pharma
- Compliance Congress for Specialty Products: Moderator - Prosecutors' Perspective - Enhance Compliance Strategy with Insights on high-priority Risks for Specialty Pharma
- Compliance Congress for Specialty Products: The Importance of Focus Arrangements and Strategies to Effectively Manage Risk
- Compliance for Specialty Products: Improve Compliance Effectiveness Through Risk-Based Monitoring
- FMV Congress: Global FMV Compliance for Third-Party Service Providers
- FMV of HCP and Investigator Payments: Analyze Trends of Global Physician Spend and Reporting to Streamline Internal processes and Ensure Accuracy
- FMV of HCP and Investigator Payments: Examine the Need for HCO Engagement Risk Management in Evaluating IIS Grants
- Global Anti-Corruption and FCPA Compliance Congress: Design an FCPA-Compliance Global FMV Methodology for HCPs
- Managed Markets Compliance Congress: Balancing Compliance Risks and Commercial Opportunities in Partnering with Customers
- Managed Markets Compliance Congress: Balancing Compliance Risks and Commercial Opportunities in Partnering with Customers
- Medical Affairs & MSL Excellence Forum: The Role of the MSL in Cultivating KOL Relationships and Managing the Risks of Collaborative Research
- Medical Affairs Advancement Forum 2017: The Role of the MSL in Cultivating KOL Relationships and Managing the Risks of Collaborative Research
- Medical Affairs Excellence Forum: Patient and Caregiver Interactions: Addressing the Risks and How they can be Overcome
- Pharma/Bio/Device Internal Audit Summit: Auditing Cross-Border Spend Capture and Reporting
- Pharma/Bio/Device Internal Audit Summit: Continuous Control Monitoring
- Pharmaceutical Compliance Canada: Understand Compliance Risk Associated with Patient Support programs Educating HCPs Compliantly through OLAs
- Pharmaceutical Compliance Congress Canada: Implementing a Data Collection and Data Management Process to Support Transparency Reporting and Beyond
- Pharmaceutical Compliance Congress Canada: Luminary Discussion on the Need for Transparency
- Pharmaceutical Compliance Congress Canada: Managing Third-Party Relationships
- Pharmaceutical Compliance Congress: Adapt Compliance Policies to Respond to Unique Risks Associated with Specialty Drugs
- Pharmaceutical Compliance Congress: Mitigate Compliance Risks Associated with Unique Challenges, nuances, and Promotion of Specialty Drugs
- Pharmaceutical Compliance Congress: Third Party Due Diligence in the U.S. and Abroad
- Specialty Product Distribution and Channel Optimization: Balancing Compliance Risks and Commercial Opportunities in Partnering with Customers
- Transparency & Aggregate Spend: Co-Moderator - Leverage Open Payments Data to Minimize Risks
- Transparency & Aggregate Spend: Fair Market Value of HCP and Investigator Payments
- Guest Lecturer – Global Healthcare Compliance Risk Management, Institut Européen d'Administration des Affaires (INSEAD)
Location
New York, NY
Education
Bachelor of Science in accounting
University of Pittsburgh
Healthcare Compliance Certificate
Seton Hall Law School
Executive Education
Leading Professional Services Firms
Harvard Business School
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