Associate Director, Auditing/Monitoring (Ethics & Compliance)

Associate Director, Auditing/Monitoring (Ethics & Compliance)
To support the auditing and monitoring function across Ethics & Compliance and Novartis Pharmaceuticals Corporation (NPC).

Major Accountabilities:

Audit and Monitoring
• Lead aspects of the Ethics & Compliance annual audit and monitoring plan based on risk assessments, results of current and prior audit and monitoring activities, outcomes from investigation process, risk assessment, and other relevant sources. Partner with key stakeholders to ensure alignment across or-ganization.
• Support independent and systematic examination of Company activities and interactions with Health Care Professionals to ensure compliance with laws, regulations, Code of Conduct, business principles, related policies and proce-dures
• Effectively conduct and communicate audit and monitoring observations and develop remediation plan with key stakeholders and executive management.
• Oversee collection, review and monitoring of management responses and remediation action plans.
• Coordinate workload of third party vendor to ensure performance consistent with contract. Address performance issues as needed, while maintaining relationship.
• Support and oversee relevant ongoing training to ensure skills and knowledge are maintained at the levels required for comprehensive and effective conduct of audit and monitoring activities
• Establish credible and collaborative business relationships across the organization with functional areas for the identification of issues that may require inclusion in audit and monitoring activities.
• Ensure adherence to and maintenance of established work programs and pro-cesses, timely and effective implementation of any new deliverables based on the outcome of audit and monitoring.

Key Performance Indicators:

• Impact and effectiveness of the monitoring and auditing program
• Collaboration with stakeholders across the organization via consulting on risk-based approaches
• Timeliness, quality and completeness of data analysis
• Value of deliverables (i.e. trends identified, data correlations made, level of risks mitigated via proactive trend identification)
• Proactive identification of potential risk management areas of focus based on in-sights and analysis
• Improved transparency of reporting and root-cause analysis
• Organizational impact
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 preferred.

Experience required/ preferred:
• 5-7 years industry pharmaceutical experience
• >2 years experience in conducting Pharmaceutical Compliance audit and monitoring activities or a related or equivalent discipline such as Internal Audit, Quality Assurance/Quality Compliance, audits

Key Desired Competencies:
• Strong analytical and systems analysis skills and ability to communicate business requirements and methodologies
• Solid working knowledge of federal healthcare regulations, FDA and OIG laws/guidelines in relation to compliance program administration within the pharmaceutical industry
• Extensive knowledge of comprehensive Pharma compliance audit techniques including risk identification, and data analytical skills
• Ability to analyze systems and processes and identify opportunities to streamline and optimize and articulate ideas in a clear and concise manner
• Strong partnering skills and ability create productive working relationships with stakeholders
• Strong interpersonal, communication, and presentation skills
• Political savvy and the ability to effectively take a difficult or unpopular position in order to present factual observations and identified risks
• Ability to manage conflict and remain calm under stress
• Successful and effective Third party management oversight and coordination expertise;
• Ability to simultaneously handle multiple tasks and meeting project deadlines
• Demonstrated ability to work cross functionally at all levels of the organization
• Demonstrate flexibility, willingness to initiate and take on new tasks and ability to effectively operate in a fast paced environment
East Hanover, NJ
Novartis Pharmaceuticals
Legal & Intellectual Property & Compliance
Full Time