Director, Compliance

Role Summary

The Director, Compliance reports to the Head of Commercial Legal and 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.

Responsibilities

• Assume primary responsibility for all compliance policies and educating business stakeholders in their application; Working collaboratively, draft, implement, administer and maintain relevant compliance policies, procedures, work instructions, and training programs.
• Assist with providing strategic direction across all OIG seven elements of an effective compliance program leveraging knowledge of industry best practices.
• Manage and implement compliance guidance related to engagements with healthcare professionals, as well as policies related to clinical studies, sponsorships, and grants.
• Lead the development, implementation, and ongoing oversight of federal and state transparency reporting programs, including Open Payments (Sunshine Act) and state-specific disclosure requirements. Ensure timely and accurate data collection, validation, and submission in alignment with regulatory expectations and internal compliance standards. Collaborate cross-functionally with Legal, Finance, Medical Affairs, and Commercial teams to build scalable systems and processes that support transparency, mitigate risk, and promote ethical business practices.
• Assist with designing, implementing, 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 and deliver effective compliance training programs to employees, enhancing awareness and understanding of ethical standards and legal obligations.

Qualifications

• 8+ years (with a B.S. degree), or 6+ 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

Skills

• 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.
• Experience managing compliance programs, including drafting policies, implementing training standards, undertaking 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 assist in the implementation of technical solutions to manage the HCP engagement processes.
• 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.

Education

• Bachelor's degree at minimum
• MS or JD degree strongly preferred