Manager Medical Governance & Operations @Novartis

Job Description

Major Responsibilities

• Lead the end-to-end medical governance of regulated (GxP) activities (IS, NIS, IIT, MAP, RC, RWE), ensuring alignment with Medical tactical plans and priorities.
• Provide expert advice and guidance to activity/business owners on processes related to due diligence, governance, and oversight of Third Parties involved in Evidence and Data Generation activities, including the reporting and dissemination of data through Scientific Engagement & Communications and Medical Information Services (SEC & MI).
• Manage the SSA Local Medical Affairs Governance Committee (LMAC).
• Serve as the local SSA expert on Novartis processes and standards, ensuring adherence to them and referring to local regulations when necessary.
• Support data quality and integrity within SSA medical affairs.
• Offer governance support, advice, coaching, and expertise to activity owners and relevant teams.
• Monitor the progress of issues, ensure escalation when needed, and track follow-up until resolution.
• Track and report key performance indicators (KPIs) and key quality indicators (KQIs) using existing global systems and tools.
• Proactively identify risks and support risk management and mitigation strategies.
• Ensure the proper classification of local medical activities.
• Oversee audit and inspection readiness and execution at the SSA level, working closely with regional/local Quality Assurance (QA) and Global Medical Affairs (GHMA) GOT teams.
• Track deviations and support the implementation and resolution of Corrective and Preventive Actions (CAPA) raised during audits/inspections at HQ level.
• Proactively identify root causes and implement actions to improve future audit and inspection outcomes.
• Understand and advise on the systems that enable key processes, providing guidance to activity owners.
• Act as the single point of contact for partner functions, including Development, QA, Ethics-Risk-Compliance (ERC), Patient Safety, Global Medical Affairs (GMA), Procurement, and others.
• Actively participate in global/regional cross-divisional medical governance networks to promote continuous improvement.
• Align and share common objectives across these networks, ensuring consistent and harmonized governance and training across medical affairs.
• Track the execution of training for the SSA Medical Team in close collaboration with the GHMA GOT.

Key Performance Indicators

• Local implementation of GMA standards with compliant execution of activities, while identifying and mitigating potential risks.
• Identification of compliance risks with well-defined processes and appropriate internal controls.
• Successful completion of internal audits with no critical findings for assigned functions and responsibilities.
• Timely implementation of preventive action plans.
• Oversight of established KPIs/KQIs on systems such as GxP Training Compliance.

Impact on the Organization

• The role directly impacts Novartis’s reputation at the global, regional, and local levels.
• It has a significant effect on local business practices and compliance standards.

Decision-Making

• Collaborate and align with GHMA GOT, Ethics-Risk-Compliance, and other GxP line functions at the local level.

P&L / Associates

• Individual contributor role.

Background & Experience

• Excellent command of English (oral and written).
• Scientific Degree, PhD, PharmD, or equivalent.
• Minimum of 5 years of relevant experience in the pharmaceutical industry.
• In-depth knowledge and understanding of:
  • Both scientific and operational aspects of clinical drug development.
  • GCP, ICH, and relevant regulatory guidelines.
  • GMA standards and Novartis SOPs.
• Strong leadership, planning, and management skills.
• Excellent communication skills, with the ability to simplify complex information.
• Expertise in process excellence and change management to foster a culture of ethical standards and compliance.
• Strong negotiation and problem-solving skills, bridging the gap between scientific and business interests.
• Proactive team player with the ability to manage effective international and matrix collaboration.

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