US-NJ, Global Drug Development, Ethics & Compliance Functional Advisor 215486BR-MZ
Global Drug Development, Ethics & Compliance Functional Advisor
Global Drug Development
East Hanover, NJ
Legal & Intellectual Property & Compliance
To provide independent, strategic business partnership with the Global Drug Development (GDD) staff 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 Novartis policies, laws, regulations and professional codes of conduct.
Competent, Compliance Advisory Services: Provide sound leadership and business decision advisory support to the US GDD Organization as an independent compliance associate 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. In addition will drive simplification in both formulation and execution of GDD processes and procedures.
Strategic Vision Alignment: Support the Compliance Program and related culture of integrity and compliance for US GDD Organization, in collaboration with the strategic partners within GDD and Ethics and Compliance; this should set the direction for the aligned approach to compliance, as well as support key metrics for evaluation within GDD; Risk Assessment, Monitoring, Remediation Plans: Provide guidance for the development and administration of GDD s 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 GDD according to BPO/E&C protocols, and report results ; identify and oversee inquiries for review and coaching by the business with proper results re-porting
Compliance Reporting, Data Analytics, and Root Cause Analysis: Liaise with GDD staff 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 GDD specific activities and results, or proactively to address organization trends.
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 Business Unit.
Business Insights: Share insights and strategic knowledge related to the products, strategies, and trends of GDD with E&C associates
Compliance Projects: Support the execution within GDD 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/suspected gaps.
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
5-7 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, cGCP, codes, guidance s (e.g., OIG program guidance), Federal Sentencing Guidelines, NPC CIA.
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