Job Description

Responsibilities Lead the design, implementation, and continuous evolution of the U.S. compliance program, including policies, procedures, and controls, ensuring alignment with global frameworks while addressing U.S.-specific regulatory requirements Review and implement (where possible) technology-enabled tools to improve program efficiency and effectiveness, including AI-driven monitoring tools and data analytics to enhance risk detection Provide strategic compliance guidance to Commercial, Medical Affairs, Market Access, Regulatory, and other functional teams Conduct compliance risk assessments and develop mitigation strategies across key risk areas Oversee compliance training, monitoring, and auditing activities to ensure ongoing effectiveness and undertake compliance risk assessments Partner with Legal to manage internal investigations, issue resolution, and remediation efforts Support product launches and business initiatives with proactive compliance guidance Lead responses to audits, regulatory inspections, and government inquiries Build, lead, and develop a high‑performing compliance team Serve as a key influencer to senior leadership, helping shape compliance strategy and culture Champion and embed a culture of integrity, accountability, and patient‑centric decision‑making across the U.S. organization, influencing behaviors at all levels of the business Adapt and operationalize global compliance policies, training, and communications to align with U.S. regulatory requirements and evolving business needs Implement KPIs, create dashboards and regular reports to senior and global leadership Serve as a strategic and trusted advisor to senior business leaders, providing pragmatic compliance guidance that effectively balances risk management with business enablement Requirements Bachelor’s degree in Law, Finance, Business, or related field required; advanced degree strongly preferred (JD, MBA, MPH or PharmD) Certified Compliance & Ethics Professional (CCEP) or equivalent preferred; additional certifications (e.g., CHC, CIA) a plus Deep knowledge of pharmaceutical-related regulations (e.g., Anti‑Kickback Statute, False Claims Act, FDA promotional regulations, Sunshine Act / Open Payments and state transparency laws, Medicaid Drug Rebate Program and 340B considerations) Demonstrated expertise in enterprise risk management, corporate compliance program requirements (incl., OIG expectation, DOJ guidance, scientific exchange vs. promotional boundaries, field force compliance and monitoring frameworks), and regulatory governance Familiarity with HIPAA and patient data considerations, contracting and FMV principles Strong leadership and stakeholder management skills with ability to influence executive levels Exceptional analytical, problem‑solving, and decision‑making capabilities Proven ability to translate complex regulatory requirements into practical business controls and policies High degree of integrity, sound judgment, and commitment to ethical standards 8‑10 years of progressive experience in compliance, legal, risk, or audit within complex, highly regulated environments Proven track record designing, implementing, and scaling enterprise‑wide compliance programs and frameworks Experience partnering with business leaders to embed compliance into strategic decision‑making and operations Demonstrated success managing regulatory examinations, audits, and remediation initiatives Experience leading investigations, managing compliance risk assessments, and overseeing corrective action plans History of building and leading high‑performing compliance and/or risk teams Ability to anticipate regulatory trends and proactively adapt compliance strategies to evolving requirements Expertise developing training, awareness programs, and initiatives that promote a strong culture of ethics and compliance Experience interfacing with regulators, external counsel, and internal audit functions at a senior level Demonstrated ability to leverage data analytics and technology to enhance compliance monitoring and reporting #J-18808-Ljbffr

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