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Ethics and Compliance Business Partner Director - Rare Disease

$187.1k - $327.5k

Initial Therapeutics, Inc.

About the Department At Novo Nordisk, we’re committed to building the best Ethics, Compliance & Privacy (ECP) team in the pharmaceutical industry. The team designs and implements solutions to complex issues, provides training, audits policies, and reports compliance‑related matters, ensuring adherence to regulatory and corporate standards. The Position Reporting to the Senior Director, Ethics & Compliance (E&C), this role serves as a strategic compliance advisor and trusted partner to senior leaders across Commercial, Medical Affairs, Market Access, Legal, Finance, HR, and other key functions within US Operations. The role combines deep compliance expertise with data‑driven risk insights to help the business make well‑informed, risk‑based decisions while ensuring activities are executed ethically and compliantly. Relationships This position reports to the Senior Director, Ethics & Compliance and works closely with stakeholders within NNI’s business functions and therapeutic areas that the role supports. It collaborates with the E&C Leadership team, NNI Legal team, E&C colleagues across Novo Nordisk globally, and leaders across lines of business while serving as an E&C Business Partner. External relationships include vendors, consultants, and the broader ethics and compliance network within the industry. Government agencies as required. Essential Functions Risk Assessment & Data-Driven Insights: Develop and implement enterprise risk assessments using data analytics, internal/external benchmarking, and enforcement trend analysis to proactively identify and prioritize top compliance risks. Leverage advanced analytics and technology tools (including AI) to identify outliers, assess executional risk, and present actionable risk insights to leadership and governance bodies. Continuously monitor the external regulatory landscape to anticipate emerging risks and inform mitigation strategies. Strategic Business Partnership: Serve as the dedicated E&C Business Partner for assigned business areas, advising senior leaders on complex compliance scenarios and ensuring compliance considerations are embedded in critical business decisions. Foster trusted relationships with business leaders to provide timely, practical guidance on new initiatives, operational risks, and interactions with healthcare stakeholders. Partner with Legal and cross‑functional teams to review and approve processes, advise on regulatory obligations, and support remediation of potential violations. Monitoring & Remediation: Design and execute risk‑based monitoring programs for field and business activities, including speaker programs, advisory boards, consulting arrangements, conferences, sampling, grants, corporate sponsorships, conflict‑of‑interest disclosures, and donations. Conduct live and transactional monitoring; analyze data to identify trends and implement preventive education or additional monitoring as needed. Perform root‑cause analysis in partnership with business leaders and drive corrective and preventive action plans, including remediation arising from investigations. Policy Development: Draft simple, clear, principle‑based policies that empower the business to operate ethically and efficiently. Regularly review and update policies to reflect changes in the regulatory environment and business needs. Training & Culture: Establish and manage a network of Ethics Ambassadors within assigned business units to integrate compliance messaging. Deliver Ethics & Compliance training and presentations at all levels of the company, including live field‑based training. Governance & Reporting: Lead E&C participation on relevant committees and working groups; regularly report on risk trends, mitigation progress, and program effectiveness to E&C and business leadership. Document all E&C activities per program expectations and support broader E&C program execution. Maintain current understanding of laws and regulations applicable to pharmaceutical compliance, assist with interpretation of state and federal law from a compliance perspective. Enterprise Leadership: Act as a visible and credible compliance leader across the enterprise, championing a culture of integrity and ethical decision‑making at all levels. Represent the E&C function in senior leadership forums, governance committees, and cross‑functional working groups, contributing a compliance perspective to enterprise‑wide strategic initiatives. Collaborate with global and regional E&C leaders to align compliance strategies, share best practices, and ensure consistent program execution across markets and business units. Drive enterprise‑level culture initiatives by identifying and leveraging key stakeholders and cross‑functional resources to embed compliance messaging into established business processes and training cycles. Serve as a recognized thought leader and subject matter expert, representing Novo Nordisk’s ethics and compliance program externally and contributing to the advancement of the compliance field. Physical Requirements 20–30% overnight travel required. Qualifications A Bachelor’s degree required; an advanced degree (MBA, JD, CPA, or equivalent) strongly preferred. Minimum of 12 years of compliance, legal, audit or regulatory experience within life sciences, with at least 5 years in an advisory role counseling senior clients or leaders in compliance, legal, risk, or regulatory. Preferred business experience in Consumer Compliance, Government Pricing, Payer Relationships, Research & Dev. Regulatory requirements, Pharmacovigilance, Quality, Rare Disease, Direct to Consumer distribution models, etc. Experience with OIG compliance guidance and US Federal Sentencing Guidelines. Demonstrated knowledge of FDA, Anti‑Kickback Statute, PhRMA code, Stark Law, False Claims Act, HIPAA, HITECH, state privacy laws, CAN‑SPAM, DOJ Security, and other relevant federal and state spend reporting requirements. Experience advising on risk and enterprise‑critical decisions. Strong enterprise business acumen and data analytics skills. Proven influence on business decisions and cross‑functional alignment. Entrepreneurial spirit, strong executive presence, proactive judgment, and ability to work effectively on cross‑functional teams. Leadership in industry forums and continuous awareness of regulatory trends. Compensation and Benefits The base compensation range for this position is $187,100 to $327,500. Base compensation is determined based on a number of factors. The position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long‑term incentive compensation and/or company vehicles depending on the position’s level or other company factors. Employees are also eligible to participate in company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flexible vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. #J-18808-Ljbffr

Vacancy posted 13 hours ago
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