The position is responsible for leading the Ethics & Compliance (E&C) Policy & Strategic Excellence group. This role has direct oversight and management of the healthcare compliance policy for Novartis Pharmaceuticals Corporation, Compliance Innovation programming, E&C’s strategy and operations, as well as other projects essential for advancing the Novartis Pharmaceuticals Corporation’s (NPC) compliance program.
• Provide strategic leadership and oversight related to the implementation of NPC’s Compliance Program
• Strategy & Operations
o Ensure effective implementation of NPC’s Ethics and Compliance related strategic imperatives
o Lead and manage the efficient and effective operations of the activities of the Ethics & Compliance department, including all areas designed to foster and administer an effective compliance program
o Manage the operations and administration of NPC Compliance Committee and related Charter and serves as secretary for NPC’s Compliance Committee
o Provide comprehensive, coordinated reporting of E&C related metrics to all relevant stakeholders, and reports for Committees, Boards, and other related organizations
o Establish, administer and evolve effective measurement of the company’s compliance program, including the activities of the E&C department as well as insight into the distinct business units and functional areas of the company.
o Establish and lead forums for effective open lines of communication (e.g., FAQs, E&C tools and resources as reference sources, etc.)
o Assume a proactive role in the development and maintenance of strategic relationships with internal and external stakeholders and various constituents cross-organizationally
o Serve on the E&C Leadership Team to help guide the organization in achievement of its objectives, with flexibility and nimbleness to manage dynamic organizational change
o Lead content development and administration of E&C strategic and tactical Leadership Team meetings
o Support CCO in aligning and implementation of relevant US Cross-divisional activities.
o Lead the preparation, review/approvals, and timely submission of all regular and ad-hoc reports and presentations to NPC and Novartis AG Senior Management, the NPC Board of Directors, the Novartis Finance and Novartis Corporation Boards of Directors, and the Country Executive Committee.
o Assess and coordinate department processes and procedures, with a continuous focus on executing streamlining and efficiency opportunities
o Manage the department’s operational budget (>$20 Million) and ensure timely and accurate reporting and spending.
o Lead E&C annual Strategic Planning and Objective setting process
o Partners with HR to develop annual compliance objectives/evaluation criteria for all NPC associates with effective and timely communications to organization; Coordinate the same across the US Divisions to align where feasible.
o Lead the development and execution of E&C department team-building, social interactions to connect the broader team and E&C community.
o Partner with HR to organize key talent initiatives including talent discussions sessions, year-end performance calibrations, and managerial skill building sessions.
o Establish and maintain (timely) proactive, relevant and comprehensive written standards including development and alignment of written standards, including Healthcare Compliance policy, reflective of NPC’s mission and values and responsive to internal and external law, regulation and guidance
o Advise NPC’s and E&C leadership as well as members of key governance functions (e.g., EOC, Governance Boards, etc.) on healthcare compliance policy and written standards
o Provide leadership and business decision support pertaining to laws, regulations, agency guidances and policy for assigned functional area(s).
o Assess and coordinate policy and written standards development processes and procedures, with a continuous focus on executing streamlining and efficiency opportunities
• Compliance Innovation
o Co-develop strategy for new P2P (peer-to-peer) educational models for NPC including Pharma and Oncology with Director of Compliance Innovation
o Support and oversee implementation Peer-to-Peer educational model assessment and implementation inclusive of training and communications
o Assess functional processes and identify process improvements, ensure existing policies and procedures are effectively, compliantly and consistently executed
o Oversee communications, change management and related training to ensure effective implementation throughout NPC’s promotional teams in Pharma and Oncology
Key Performance Indicators:
• Efficient and effective operations of the activities of the Ethics & Compliance department
• On time and accurate delivery of Compliance Innovation projects
• Developing and maintaining written standards
• Bachelor’s Degree or equivalent 4-Year University degree. Advanced degree preferred.
• Healthcare Compliance Certification or other relevant certification program
Knowledge & Skill Requirements:
• Minimum 10 years of experience in the pharmaceutical industry and an emphasis on compliance program administration; in-depth knowledge concerning the operation of multiple functions in a pharmaceutical manufacturing and distribution organization and the regulatory/compliance requirements (e.g., Federal healthcare and FDA laws, regulations, guidance)
• Demonstrated track record of leadership experience
• Demonstrated ability to work in high stress situations balancing multiple tasks simultaneously
• Exceptional communication (written and oral) and presentation skills
• Excellent analytical/reasoning, problem solving, organizational and multi-tasking skills
• Excellent interpersonal skills working in teams and across a diverse stakeholder matrix
• Understands and embraces multi-faceted platforms and technologies and pedagogical styles
• Strong knowledge in all key elements of pharmaceutical compliance program (CIA, policy, monitoring, risk assessment, reporting, etc.)
• Strong policy, process and project management skills
• Strong interpersonal skills working in teams and across a diverse stakeholder matrix
• Strategic planning/forecasting and execution skills
• Financial/accounting skills for effective budget management
• Organizational and project management skills
• Demonstrated track records on success, strategy skills, and contributions to the business and enhancing business models and performance.
• Demonstrated ability to operate with a high degree of autonomy and competence in the execution of these job responsibilities, with an ability to leverage a cross-functional network to seek specific guidance and expertise as warranted in a solutions-focused approach.
• Ability to travel up to 25%