About The Role
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
Apply via :
www.novartis.com