Manager - Medical Governance & Operations Job at Novartis Pharma Services

Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines

We are recruiting to fill the position below:

Job Position: Manager - Medical Governance & Operations

Job ID: REQ-10033373
Job Location: Ikeja, Lagos

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.

Skills:

• Leadership and proven planning and management skill
• Strong communication and ability to communicate complex information in simple terms
• Process excellence
• Change management mindset to sustain a culture of high ethical standards and compliance
• Negotiation and problem-solving skills for bridging between scientific and business.
• Proactive and team-player approach for managing effective international and matrix collaboration.