Major accountabilities:
- Ensure Compliance Risk Assessment & Testing is executed for all countries in scope within the stipulated timelines
- Support countries in preparation of Internal Audit and Central Monitoring visits (incl. third party audits).
- Identify and flag opportunities for simplification of process, controls, learnings, and sharing best practices from previous IAs, CM visits, RAM testing, Speak-up cases etc.
- Ensure lessons learnt are appropriately cascaded within region and global.
- Pro-actively identify and detect risks, prioritize them, and work with broader ERC team, as appropriate, on pragmatic risk mitigation plans and execution.
- Ensure sustainable remediation plans for top risks - lead the development and execution of effective remediation activities e.g. issues identified during RAM Monitoring, IA or Central Monitoring reviews.
- Conduct local investigations and coordinate IRC meetings
- Provide country-wise snapshot on overall risks and control environment across key metrics (Key Risk Indicators), enabling pro-active risk identification & follow through of needed actions
- Identify areas of enterprise-wide risk management improvement programs
- Escalate to Senior Management risk topics not resolved and inform them regularly about key risks and mitigation actions.
- Provide periodic assurance updates @ Country / Cluster LTs and engage with senior leadership to drive management attention.
- Run training sessions/ workshops for enhancing risk awareness across assigned countries.
- Under the direction of leadership and in close collaboration with the Country ERC Heads and Representatives from other Functions, the Legal and Compliance Project Manager has the following responsibilities: -Project Management: Establishes project management office and provides project management support ; Defines project scope, goals and deliverables; develops full scale work plans and executes project work plans; manages day-to-day operational aspects of a project independently and coordinates project staff; manages project budget, Plans and schedules timelines, Manages and directs external agencies towards the project objectives, reviews deliverables prepared by external agencies; Monitors and reports on progress of the project to Project Lead; prepares status reports with project progress and presentation for senior management; ensures project documents are complete, current, and stored appropriately -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- Comprehensive fit for purpose Risk & Assurance strategy, and timely execution of key deliverables with high meaningful impact
- Effective support is provided to the countries in scope in relation to RAM Monitoring and management of SpeakUp cases.
- Trends are timely identified and acted on, as required. Insights and recommendations are provided to help ensure fit for purpose actions.
- Ability to prioritize key risks or issues that may have a significant impact on the organization.
- Collaboration with key partners, including Country / Region ERC, IA, Speak-up Office, and other peers within Risk & Operations
- Qualitative inputs from internal stakeholders are sought to identify continuous improvement opportunities in content and delivery of International Risk and Assurance support.
- Cluster team s (assigned countries) risk awareness, mindset, and ability to manage risks actively & effectively continues to mature and strengthen.
Minimum Requirements:
Work Experience:
- 7 yearsof top tier consulting experience, finance /audit or Ethics, Risk & Compliance (ERC) experience, preferably in pharmaceutical, device or healthcare industries with relevant exposure to ERC function or related components preferred
- Experience in a highly regulated industry with its dynamics, regulatory framework
- Proven ability to lead complex projects and collaborate within and across cross-functional teams and business units, in a matrixed environment.
Knowledge
- Knowledge of healthcare industry, laws and regulations
- Knowledge of Ethics, Risk, Compliance Program structure and administration
- Certification status a plus
- Project Management
Technical/Functional Skills
- Project Management
- Results driven, focused and problem solving
- Effective communication/presentation skills with all management levels
- Strong collaborator, networking and relationship management
- Strong analytical and testing skills (qualitative and quantitative aspects)
- Risk identification and monitoring techniques
Competencies (based on Novartis Personal Effectiveness Competencies)
- Being Resilient
- Organizational Savvy
- Operational Excellence
- Stakeholder Engagement
- Applied Business Insights
- Continuous Learning/Dynamic Knowledge
- Digital and Technology savvy
Languages :
Skills Desired
Business Networking, Compliance Management, Compliance Risk, Curiosity, Flexibility, Law (Legal System), Leadership, Operational Risk, Operational Risk Management, Regulatory Reporting, Risk Control, Risk Management, Senior Management, Software Frameworks
