| || 225096BR |
| || Director, Ethics & Compliance Functional Advisor, PA/HP |
| || PHARMA |
| || US GEN MED |
| || USA |
| || East Hanover, NJ |
| || Novartis Pharmaceuticals |
| || Legal & Intellectual Property & Compliance |
| || Full Time |
| || Regular |
| || To provide independent, strategic business partnership with the Patient Access/Health Policy (PA/HP) Function to anticipate and identify proactive strategies/solutions to address business needs and potential risks, and help ensure that activities and processes comply with all applicable NPC policies, laws, regulations and professional codes of conduct.
• Competent, Compliance Advisory Services: Provide sound leadership and business decision advisory support to the PA/HP Function as the primary and independent compliance consultant to help enable the achievement of business goals, objectives, and innovative new approaches in a manner that achieves compliance with company policy, laws and regulations, relevant guidance, codes and Corporate Integrity Agreement requirements
• Strategic Vision Alignment: Lead the development of a Vision for the Compliance Program and related culture of integrity and compliance for assigned Function, in collaboration with the Function Unit Head and Chief Compliance Officer; this should set the direction for the aligned approach to compliance, as well as establish key metrics for evaluation within the Business Unit; this execution is to be led by the Function Unit Head and his/her Leadership Team
• Risk Assessment, Monitoring, Remediation Plans: Strategic advisor to help guide the Function’s development and administration of their Risk Assessment Plan, related self-monitoring plans, aggregated NPC risks and any other relevant remediation plans, with feedback loops to E&C for measurement and reporting
• Monitoring and Investigations Oversight: complete relevant training in order to effectively conduct compliance monitoring and inquiries assigned by the BPO related to respective Function according to BPO/E&C protocols, and report results to E&C; identify and oversee inquiries for review and coaching by the function with results reporting to E&C
• Compliance Reporting, Data Analytics, and Root Cause Analysis: Serve as Function/E&C liaison to help ensure effective and comprehensive awareness and action plan development related to the results of any dashboard/KPI metrics and reporting pertaining to the effectiveness of the compliance program as it relates to specific Function activities and results, or proactively to address NPC organization trends.
• Trends and Knowledge Sharing: Provide current information for the function on known and foreseen internal and external compliance trends to proactively guide and adjust business initiatives accordingly
• CIA Compliance: Partner with CIA team and functional areas to ensure effective, timely and complete execution of all CIA-related deliverables and any relevant audit remediation within assigned Function
• Business Insights: Drive education and strategic knowledge of E&C associates related to the products, strategies, and trends of assigned Functional Unit
• Compliance Projects: Drive execution within assigned Function of new compliance-related policies, initiatives or projects
• “Speak Up” Culture: Promote and facilitate a continuous learning environment via the identification and communication of actual or suspected gaps or failure to adhere to NPC policy, laws and regulations by Functional associates in accordance with NPC Code of Conduct reporting obligations
• Continuous Learning: Develop and administer Function specific educational programs and training consistent with the core goals of E&C educational curriculum, with further specificity to address Function needs in coordination with Head of E&C Learning & Education, and across other Functional & BU advisors for consistency
• Ad-Hoc Projects: Other ad-hoc compliance projects as assigned.
• Contribute as active member of E&C Leadership Team and respective Functional Leadership Team
Key Performance Indicators:
• Alignment and ownership of E&C Strategy and setting unique Function vision for compliance program by Functional Leadership.
• Culture of integrity and compliance within the Function as measured by relevant surveys (e.g., GES, CIA independent expert reports and focus groups, etc.)
• Trust built with all Functional Associates (e.g., measures of accessibility, solutions orientation, ability to effectively and appropriately advise under challenging or controversial circumstances)
• Number/Nature of policy violations from Function, including responsiveness in remediating in timely manner and sustained outcome of compliance
• Quality/speed of advice provided to resolve issues, including consistency of advice (requiring strong collaboration across E&C and with Functional Legal partner
| || The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. |
| || Education (minimum/desirable):
• Bachelor's Degree or equivalent 4 Year University Degree required
• Advanced degree e.g., Masters in Juris Prudence, JD, or other high-level education relevant to the practice of law and/or healthcare compliance expertise preferred
• Completion of relevant certification program preferred (e.g., Seton Hall Healthcare Compliance Certification, ECI LPEC Certification)
• >10 years’ experience in the pharmaceutical industry
• In depth understanding of the operations of a pharmaceutical company including manufacturing, marketing, sales, and distribution.
• Strong knowledge of relevant regulatory/compliance requirements (e.g., Federal HealthCare Program and FDA laws, regulations, codes, guidances (e.g., OIG program guidance), Federal Sentencing Guidelines, NPC CIA
• Strong Knowledge of Managed Health Care Environment, Contracting, and/or Patient Services including relevant regulations.
• Understanding of Specialty Pharmacies and related service providers
• Excellent interpersonal skills and ability to develop trusting relationships with stakeholders
• Strong partnering skills to identify and leverage knowledge from across the organization
• Excellent analytical/reasoning, problem solving, organizational and multi-tasking skills
• Strong policy, process and project management skills
• Excellent presentation skills and executive presence.
• Experience developing content and delivering quality education programs
• Demonstrated ability to establish strong external networks accessed and relationships built with experts in the field, industry peers and regulatory authorities to remain current on compliance and other industry related trends
• Demonstrated ability to prepare and deliver analytical, written and oral communications appropriate for multiple audiences and levels within the organization
• Demonstrated track record of partnering with business to establish a common vision to enhancing business performance
• 20-30% travel required