Job ID

The role is responsible to execute an integrated risk management and assurance program for assigned countries within the region. This includes pro-actively identifying and managing key risks (incl. any emerging risks), leading the successful execution of Risk Assessment & Monitoring (RAM), local speak-up investigations and ERM for countries in-scope. In addition, role is responsible for developing and executing the approved annual assurance plan, sharing good practices and learnings in a timely manner and enabling the organization to continue to learn and strengthen our broader ERC program.

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 years of 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 :

• English.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Ethics Risk & Compliance

Innovative Medicines

India

Mumbai (Head Office)

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Hyderabad (Office), India

Legal & Intellectual Property & Compl.

Full time

Regular

No