Manager Medical Governance & Operations at Novartis

Major accountabilities:

• Lead the End-to-End medical governance of regulated (GxP) activities (IS, NIS, IIT, MAP, RC, RWE), in alignment with Medical tactical plans and priorities
• Advise and guide the activity/business owner to implement processes related to due diligence, governance and oversight of Third Parties engaged in Evidence and Data Generation Activities, and the reporting and dissemination of the data – including Scientific Engagement & Communications and Medical Information Services (SEC & MI)
• Manage the SSA Local Medical Affairs Governance Committee (LMAC)
• Is the local SSA expert on, and monitors, adherence to Novartis processes and standards; referring to local country regulations when needed
• Support data quality/integrity in SSA medical affairs
• Provide Governance support, advice, coaching and expert input to activity owners and relevant teams
• Maintain overview and monitor progress of issues, ensure & track escalation and follow-up until resolution
• Monitor and report KPI/KQI using existing Global systems & tools
• Proactively identify risk and support risk management and mitigation
• Ensure proper classification of local medical activities
• Oversee and monitor audit & inspection readiness and execution at SSA level, in close collaboration with regional/local QA, as well as with GHMA GOT
• Track deviation and support implementation/resolution of CAPA raised during audit/inspection at HQ level
• Proactively identify root cause and implement action to improve future audit/inspection performance
• Understand the systems that enables key processes in order to give advice and guidance to activity owners
• Be the single point of contact for partner functions such as Development, QA, Ethics-Risk-Compliance (ERC), Patient Safety, Global Medical Affairs (GMA), Procurement and others
• Proactively participate in global/regional cross-divisional medical governance networks for ensuring continuous improvement
• Share common objectives across these networks for ensuring a consistent and harmonized governance and training across medical affairs
• Track execution of training for the SSA Medical Team, working closely with the GHMA GOT

Key performance indicators:

• GMA standards are implemented locally and activities are executed in a compliant way; potential risks are identified and mitigated
• Compliance risks for assigned responsibilities are identified with well-defined processes and appropriate internal level of controls
• Internal Audits without critical findings for assigned functions and accountabilities
• Preventive action plans in place and implemented in an effective and timely manner
• Oversight through established KPIs/KQIs on existing systems E. g., GxP Training Compliance

Impact on the organization:

• Role has a direct impact on the reputation of Novartis at global and regional/local level
• Direct impact on the local business practices

Decision making:

• Need to align with GHMA GOT, Ethics-Risk-Compliance and other GxP line functions locally

P&L / associates:

• Individual contributor

Background & Experience:

• Excellent English (oral and written) skills
• Scientific Degree, PhD, PharmD or equivalent.
• Extensive and relevant experience in pharmaceutical industry (at least 5 years).
• Knowledge and understanding of:
• Both scientific and operational aspects of clinical drug development
• GCP, ICH, and relevant regulations
• GMA standards and Novartis standard operating procedures