• Built/managed Healthcare Compliance Program elements, including risk-based auditing/monitoring for R&D, Medical Affairs, Commercial; developed policies/SOPs/training aligned with OIG/DOJ/PhRMA, partnering cross-functionally with Legal/Regulatory/Finance/Quality. • Owned the full lifecycle of global transparency and Open Payments compliance, including data collection, consolidation, reconciliation, dispute management, remediation, and on-time CMS submission, achieving 100% filing accuracy across $50M+ in HCP/HCO transfers of value. • Acted as primary Ethics & Compliance advisor to U.S. Commercial, Medical Affairs, Market Access, Patient Services, and leadership teams, supporting therapeutic area strategies including oncology and patient-facing programs. • Directed data quality monitoring and control activities across transparency processes, identifying and remediating source-system issues that improved completeness and accuracy and reduced reporting errors by 40% through stronger validation controls and workflow governance. • Oversaw third-party vendor performance for compliance reporting activities, managing data exchanges, discrepancy resolution, screening logic, and output validation against regulatory requirements, internal standards, and audit-ready documentation expectations. • Supported compliance-related incident responses, including intake, triage, investigations, and root cause analysis, ensuring timely resolution and sustainable corrective actions. • Partnered with Legal, Finance, Procurement, and business stakeholders to strengthen third-party and HCP/HCO contracting controls, FMV tiering, standardize statements of work, and embed compliance requirements into onboarding and payment workflows. • Led a cross-functional compliance approval for advisory boards, ISTs, sponsorship, grants, and patient education programs. • Established compliance frameworks, guidance, and internal controls for advisory boards, investigator meetings, speaker programs, and conference activities in alignment with Anti-Kickback Statute, PhRMA Code, and broader healthcare compliance expectations. • Developed actionable compliance reporting and risk insights for senior stakeholders by translating risk assessments, auditing, and monitoring and transparency data, exceptions, and trend findings into practical recommendations supporting informed decision-making and program maturity. • Designed and delivered role-based training on workflows, reporting obligations, documentation standards, and control expectations, increasing reporting accuracy, accountability, and inspection readiness across cross-functional teams. • Supported launch readiness by building technology-enabled compliance infrastructure and scalable transparency operations in a fast-paced commercial biotech environment. • Managed/coached 3-person compliance team FTEs/contractors; oversaw prioritization performance, succession planning, and collaboration.

• Directed enterprise compliance and risk management activities across clinical operations, leading risk assessments, monitoring, auditing, investigations, remediation tracking, corrective actions, and CAPA execution. • Identified and remediated 25+ control and compliance gaps, reducing audit findings by 60% within one year through root cause analysis, targeted corrective actions, stronger governance, and sustainable process improvements. • Developed and deployed compliance policies, escalation pathways, and reporting expectations that improved accountability, strengthened internal controls, and supported timely issue resolution across operational functions. • Delivered organization-wide training on compliance requirements, risk awareness, issue escalation, and remediation expectations to reinforce a proactive culture of compliance and continuous improvement.

CCEP

SCCE