Compliance Officer, US
Averitas Pharma · Morristown, NJ · 2 wk ago
HybridFull-time
About the role
As the Compliance Officer, US, you will lead and advance our U.S. Compliance & Ethics program, ensuring adherence to healthcare laws, regulations, and industry standards while enabling responsible business growth. You will serve as a trusted advisor to senior leaders, embedding compliance into business strategy and fostering a culture of integrity, accountability, and patient-centric decision-making. This role combines strategic leadership with hands-on execution, partnering closely with U.S. and global stakeholders to drive an effective, aligned compliance program in a dynamic, highly regulated environment.
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 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
- A combination of relevant education and applicable job experience will be considered
- 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 (including OIG expectations, 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
- 8-10 years of progressive experience in compliance, legal, risk, or audit within complex, highly regulated environments
Skills
- 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
- 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
Ethics and Compliance
- Demonstrates the highest level of ethics, integrity, trust while acting with courage and candor
- High accountability for your actions and results and ability to ensure a high level of commitment to the success of the organization, your peers and customers
- Operates in compliance with all applicable regulations and professional standards at all times