US-NJ, Director, Ethics & Compliance BU Advisor 220016BR-MZ
Director, Ethics & Compliance BU Advisor
East Hanover, NJ
Research & Development
To provide independent, strategic business partnership with business leadership 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 various teams (e.g., business franchises and functional departments) within the US Oncology Business Unit as the primary and independent compliance consultant to help enable the achievement of busi-ness 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 Compli-ance Program and related culture of integrity and compliance for assigned groups, in collaboration with the business leader and the Head of E&C for US ONcology; this should set the direction for the aligned approach to compliance, as well as establish key metrics for evaluation within the Business Unit; this execu-tion is to be led by the Business Unit Head and his/her Leadership Team
Risk Assessment, Monitoring, Remediation Plans: Strategic advisor to help guide the BU s development and administration of their Risk Assessment Plan, re-lated self-monitoring plans, aggregated NPC risks and any other relevant reme-diation 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 according to BPO/E&C protocols, and report results to E&C; identify and oversee inquiries for review and coaching by the business with results reporting to E&C
Trends and Knowledge Sharing: Provide current information for the business 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 effec-tive, timely and complete execution of all CIA-related deliverables and any rele-vant audit remediation within assigned groups
Business Insights: Drive education and strategic knowledge of E&C associates related to the products, strategies, and trends of assigned groups
Compliance Projects: Drive execution within assigned groups of new compli-ance-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 associates in accordance with NPC Code of Conduct reporting obligations
Continuous Learning: Develop and administer educational programs and train-ing relevant to assigned groups consistent with the core goals of E&C educational curriculum
Ad-Hoc Projects: Other ad-hoc compliance projects as assigned.
Contribute as active member of US Oncology E&C Leadership Team and respec-tive Leadership Teams of assigned groups
Key Performance Indicators (Indicate how performance for this role will be measured)
Alignment and ownership of E&C Strategy and setting unique vision for compli-ance program within assigned groups
Culture of integrity and compliance within assigned groups as measured by rele-vant surveys (e.g., GES, CIA independent expert reports and focus groups, etc.)
Trust built with all associates in assigned groups (e.g., measures of accessibility, solutions orientation, ability to effectively and appropriately advise under challeng-ing or controversial circumstances)
Number/Nature of policy violations from BU, including responsiveness in remedi-ating in timely manner and sustained outcome of compliance
Quality/speed of advice provided to resolve issues, including consistency of ad-vice (requiring strong collaboration across E&C and with BU 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.
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)
- 7 plus 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
- 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
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