Risk & Assurance Manager

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.

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

Skills Required

Operational Excellence, business insights , Stakeholder Management, Risk Management