Director, Compliance

Position Overview

The Director, Compliance reports to the VP, Legal & Compliance and supports the function in developing, implementing, and maintaining an effective Compliance Program that (1) supports and promotes a companywide culture of ethics and compliance, and (2) meets or exceeds applicable regulatory standards for effective compliance programs, including the Office of Inspector General (OIG) Guidance

Key Responsibilities

• Provide strategic direction across all OIG seven elements of an effective compliance program leveraging knowledge of industry best practices 
• Assume primary responsibility for all healthcare compliance policies and educating business stakeholders in their application
• Working collaboratively, draft, implement, administer and maintain relevant compliance policies, procedures, and work instructions
• Management and oversight of 1) engagements with healthcare professionals and patients including FMV and 2) external funding (including sponsorships and grants) in collaboration with relevant stakeholders
• Assist with designing and overseeing a comprehensive compliance monitoring program to assess adherence to internal policies, regulatory requirements, and industry standards. Lead risk-based monitoring activities across key business functions, including Commercial, Medical Affairs, and Market Access, to proactively identify and mitigate compliance risks. Develop actionable insights from monitoring outcomes, drive continuous improvement, and ensure timely reporting and remediation in collaboration with cross-functional stakeholders
• Develop training plans and deliver effective compliance training programs to employees, enhancing awareness and understanding of ethical standards and legal obligations.
• Lead the ongoing oversight of federal and state transparency reporting programs, including Open Payments (Sunshine Act) and state-specific disclosure requirements. Collaborate cross-functionally with Legal, Finance, Medical Affairs, and Commercial teams to build scalable processes that support transparency, mitigate risk, and promote ethical business practices.
• Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the compliance program, including antikickback and fraud and abuse laws, bribery and corruption, transparency laws, price reporting, OIG and DOJ guidelines, and industry standards, such as the PhRMA Code 

Qualifications

• Bachelor’s degree
• MS, JD, MBA or other relevant advanced degree strongly preferred
• 10+ years (with a B.S. degree), or 8+ years (with a graduate degree) of recent, relevant in-house experience in a compliance or related department of a healthcare organization or directly applicable law firm experience
• Direct compliance experience in the pharmaceutical or medical device industry
• Direct experience building programs and selecting and managing vendors
• Direct experience leading significant programs and projects
• Experience managing compliance programs, including drafting policies, developing and implementing training standards, leading monitoring initiatives, and conducting investigations on sensitive matters 
• Ability to apply a risk-based analysis to legal and compliance issues and develop creative and practical solutions that satisfy both business requirements and legal obligations
• Ability to manage and drive the implementation of technical solutions (e.g., dashboards, portals) to manage processes including the HCP and patient engagement processes; monitoring; investigations workflows
• Communicates complex compliance concepts effectively to the organization in a way that is connected to business objectives
• Strong oral, written and presentation communication skills with superior attention to detail
• Demonstrates initiative and excellent judgment; proactive; ability to work independently and collaboratively within a team setting; able to build relationships, both internally and externally 
• Demonstrated commitment to compliance, ethics, integrity, accountability and innovation