US-NJ, Executive Director, Risk Management Oversight Center of Excellence 215483BR-MZ
Executive Director, Risk Management Oversight Center of Excellence
US GEN MED
East Hanover, NJ
Legal & Intellectual Property & Compliance
A global healthcare leader, Novartis, has one of the most exciting product pipelines in the industry today. It is a pipeline of innovative medicines brought to life by diverse, talented, and performance driven people. All of this makes Novartis one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.
In support of the NPC Compliance Program, provide leadership and set the strategic direction for the Risk Management Oversight Center of Excellence which includes compliance risk assessment, investigations, monitoring, auditing, and compliance analytics.
Lead the administration of NPC s annual Compliance Risk Assessment process in collaboration with the NPC Business and Functional area owners. Provide regular reports to Sr. Management and relevant leadership bodies to ensure full awareness related to the results of the activities of the COE, and to guide further direction and evolution of program
Establish NPC s annual plan for E&C-led Audits, E&C-led Monitoring, and business-led monitoring and secure NPC Compliance Committee endorsement. Collaborate accordingly with Internal Audit
Partner with BPO (and Legal as warranted) to conduct comprehensive, quality, and timely internal investigations, with particular focus on potential misconduct related to Federal health care program and FDA requirements, in full adherence with company standards.
Lead the process development, documentation requirements, tracking, and assignment of non-investigation inquiries to the Business/Function and/or related E&C Advisors of the same for further review, resolution, and report back to E&C for resolution oversight, tracking and analysis.
Co-Lead Internal Review Committee with Employee Relations and Legal to review and resolve all internal investigation matters, and relevant non-investigation inquiries. Generate recommendations to the Business/Function regarding individual disciplinary actions, and systemic element corrections as warranted (e.g., policy, training).
Oversee Materials Approval Process (MAP) operations team to ensure and efficient and timely review of promotional materials
Develop and implement E&C s compliance analytic capabilities, automation and reporting, and continued evolution based on external expert insights
Develop and conduct a system and methodology of comprehensive and robust root cause analysis. Develop hypotheses and present related direction and recommendations to the business to address issues in a timely manner.
Provide actionable, regular reports to Sr. Management and relevant Committees and bodies to ensure full awareness related to the results of the activities of the COE, and to guide further direction and evolution of program
Develop strategic vision and related tactics to drive communications and culture change goals based on COE activities.
Lead and effectively remediate relevant identified gaps obtained through internal or external reviews (e.g., E&C activities, Internal Audit, External independent program reviews)
Identify and share best practices across the U.S. Group Companies to drive coordination and harmonization of compliance programs
Hire and ensure smooth on-boarding of new associates. Manage performance of associates and ensures all associates have robust, actionable development plans. Ensure all associates receive relevant training and development to support performance and career development.
Member of E&C LT
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
>10 years work experience in the pharmaceutical/biotech industry
Strong understanding of operations of a large multi-national pharmaceutical company and all applicable regulatory/compliance requirements
Completion of compliance certification program (e.g., Seton Hall Healthcare Compliance Certification) preferred
Relevant training, certification, or credentials related to the conduct of compliance-related audits, monitoring, and investigation activities preferred
Skills & Competencies
Demonstrated track record of organizational leadership (Establishing a vision, engaging a team, execution of strategy, etc.)
Demonstrated ability to work with senior management in highly matrixed environment
Excellent Influencing and Conflict Management Skills
Excellent presentation skills and executive presence
Excellent Communication Skills (Written and Oral)
Excellent analytical and problem solving skills
Understanding of compliance program administration or comparable experience preferred
Strong project management skills (Project Management and/or Six-Sigma certification preferred)
Ability to translate extensive, complex information, data and analytics into key observations and communicate effectively to senior management and other stakeholders
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