Healthcare Compliance Officer, US Biomedicine *PC 1505

Position Overview

The Healthcare Compliance Officer will serve as the lead compliance authority for the US Biomedicine organization, overseeing the design, implementation, and execution of the company's corporate compliance and privacy programs, with a strong emphasis on promotional review, HCP/HCO interactions, and data governance. This individual will function as the legal and compliance representative on the Promotional Review Committee (PRC/MLR), support compliant commercialization of pharmaceutical products, and drive enterprise-wide compliance initiatives.

This position will report to the Chief Officer, North America Biomedicine. Are you ready to start revolutionizing biomedical research? Join a family passionate about making a real impact – one breakthrough at a time.

Key Responsibilities

Corporate Compliance Strategy and Governance:

• Serve as an independent advisor to senior leadership on compliance risks and obligations.
• Establish and maintain a compliance hotline and related communication programs to foster a culture of accountability and integrity.
• Provide compliance reporting and program updates to executive leadership and the global Executive Committee, where appropriate.

Promotional Review and Commercial Compliance:

• Serve as the compliance and legal lead on the PRC/MLR team, reviewing promotional and medical communications to ensure compliance with FDA, FTC, OIG, and PhRMA Code requirements.
• Advise Commercial, Medical Affairs, and Regulatory teams on labeling, disease awareness, advertising claims, and fair balance.
• Provide real-time legal and compliance guidance on marketing tactics, speaker programs, social media, and digital campaigns.
• Support the development of compliant launch strategies and commercial plans across therapeutic areas.

Policy Development and Compliance Operations:

• Develop, implement, and update compliance policies, SOPs, and controls covering promotional practices, field activities, speaker programs, transparency, and medical engagements.
• Conduct training programs across Commercial, Medical, and corporate functions to promote awareness of compliance standards and ethical conduct.
• Monitor industry trends, enforcement actions, and evolving laws to maintain a proactive, risk-based compliance framework.

Privacy, Data Governance, and Cybersecurity Compliance:

• Lead the privacy compliance program, ensuring adherence to HIPAA, GDPR, CPRA/CCPA, and other applicable data protection laws.
• Collaborate with Product, IT, and Commercial teams to integrate privacy by design, de-identification standards, and real-world data strategies into business processes.
• Partner with Information Security on vendor assessments, breach simulations, and cybersecurity preparedness.
• Guide business teams on permissible data use, third-party data sharing, and privacy terms in commercial or clinical agreements.

HCP/HCO Engagement and Transparency:

• Provide legal and compliance oversight for interactions with healthcare professionals and organizations, including speaker programs, consulting agreements, educational grants, and charitable contributions.
• Ensure compliance with the Anti-Kickback Statute, Sunshine Act (Open Payments), and FMV guidelines.
• Support transparency reporting processes and compliance with applicable state and federal reporting obligations.

Internal Investigations, Auditing, and Risk Management:

• Lead or support internal investigations related to code of conduct or compliance policy violations; oversee appropriate remediation and documentation.
• Partner with internal audit and finance teams to monitor compliance with financial controls, SOX requirements, and commercial activity oversight.
• Identify areas of risk and develop corrective action plans, tracking and reporting key compliance metrics to senior leadership.

Required Qualifications

• Juris Doctor (JD) degree from an accredited U.S. law school; active license to practice law in at least one U.S. jurisdiction; minimum of ten (10) years of legal, compliance, or regulatory experience within the pharmaceutical, biotech, life sciences, or healthcare industry.
• At least five (5) years in a compliance, legal, or regulatory affairs role with direct involvement in promotional review and commercial compliance.
• Experience with U.S. healthcare laws including FDA promotional regulations, Anti-Kickback Statute, False Claims Act, Sunshine Act, and OIG Compliance Guidance.
• Familiarity with global and U.S. data privacy laws (HIPAA, GDPR, CCPA/CPRA), cybersecurity law, and incident response procedures.
• Demonstrated success conducting internal investigations, leading training programs, and advising on complex regulatory matters.
• Deep expertise in promotional compliance and legal risk associated with pharmaceutical marketing and communications.
• Strong knowledge of privacy, transparency, and HCP/HCO engagement regulations.
• Excellent analytical, interpersonal, and communication skills, with the ability to influence at all levels of the organization.
• Ability to translate complex legal concepts into clear, actionable business guidance.

Preferred Qualifications

• Experience working in a small, fast-paced, or pre-commercial biopharma organization preferred.