Key Responsibilities:

• Support Risk Based Quality Management (RBQM) by monitoring risk registered data in collaboration with Process Compliance Managers (PCM) to understand team behaviors towards risk management and issue documentation.
• Influence TCO teams to achieve proactive remediation and mitigation of risks and minimize occurrence of issues.
• Work with Risk Management and risk registered subject matter experts (SMEs) on all matters pertaining to trial risk management.  Ensure communication and training of Clinical Trial Teams (CTT) on risk-related processes.
• Collaborate with the Risk Surveillance Lead community in Development, sharing TCO feedback and optimizing ways of working, to achieve a mutual understanding of risk management in TCO trials and alignment of risk management approach across TCO trials.
• Liaise with Vendor Program Strategy Director (VPSD) function to align on vendor risks/issues, based on feedback collected from TCO trial teams. Communicate relevant vendor risk/issue related information to TCO trial teams.
• Serve as the Point of Contact for the global Business Disruption Committee, providing the TCO perspective, supporting risk assessments, and coordinating with teams on relevant risks/issues and related action items. Coordinate the TCO business disruption taskforce, as needed.
• Contribute to global and TCO specific work streams and initiatives, in collaboration with Operations Excellence, by supporting with risk assessment, mitigation plans, and change management. Assess changes in the broader organization that may potentially impact TCO. Set-up and implement relevant change management plans as applicable for TCO.
• Engage with relevant stakeholders within and outside TCO to build trust and ensure alignment. Ensure clear communication about changes, its benefits and risks, as applicable. Provide clear communication and maintains effective collaboration with TCO teams to enhance their understanding of change and how it benefits them and the organization, thereby reducing resistance and increasing acceptance.
• Assure sustainability of changes with continuous monitoring, feedback loops, and adjustments to ensure that the change remains effective and delivers the desired outcomes.
• May contribute as subject matter expert for risk-related Standard Operating Procedures (SOP)/Working Practices (WP) and others as applicable.

Essential Requirements:

• B.S. or advanced degree preferably in life sciences/healthcare or equivalent experience.
• A minimum 8 years of relevant experience in the Pharmaceutical or Biotech industry with experience in trial management, risk management and/or change management.
• Demonstrated ability for leading initiatives with cross-functional teams and implementation of recommendations.
• Developed or have participated in the development of guidance documents, trainings, SOPs, work practices and tracking tools.
• Experience working in matrix environment and in global teams.
• Excellent interpersonal, problem-solving, negotiation and conflict resolution skills.
• Excellent organizational, communication and presentation skills (oral and written).

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

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

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