Job Dimensions

Number of associates:

Leads the integrated Medical Governance, Evidence & Operations pillar within the country medical organization.

Financial responsibility:

Responsible for efficient resource use, overseeing budgets and vendor contracts.

Decision making:

Accountable for governance decisions, audit readiness, evidence planning and execution oversight, process improvements, and medical operations frameworks with the Country Medical Affairs Head.

External/internal stakeholders Interface:

Interfaces with Country Medical Affairs Head, Medical TA Head, EE, IMACE, Regional Field Medical Excellence, Global Medical Governance (GMA), Legal, ERC, PV, Purchasing, and cross-functional teams.

Impact on the organization:

Drives alignment and quality of medical strategy execution, strengthens capability and process harmonization, and ensures compliant and consistent medical excellence delivery.

Major Accountabilities

Medical Governance

• Ensure the highest quality standards and compliance of Novartis good practice guidelines and country regulations.
• Maintain high performance of medical operations, evidence generation, MAPs and Medical Information teams with strong integration in the therapeutic areas.
• Ensure close collaboration with DRA, Legal, Quality and Compliance (ERC) and Pharmacovigilance to maintain ethical standards of medical teams in coordination with the TAs.
• Ensure continuous review of SOPs, Medical Affairs audit findings and identify potential processes and solutions for harmonization and improvement.
• Promote adequate interaction and alignment with regional, international (IMACE) and Global Teams (GMA, SSO), act as point of contact for the relevant stakeholders at local, regional, international or global level; maintain local operational governance by ensuring and actively championing end to end oversight and continuous process improvement.

Evidence Generation

• Evaluate options and opportunities for gathering RWE data from current portfolio and pipeline according to product strategies.
• Evaluate status of ongoing observational studies, RWE, and other data generation activities.
• Track budget related to Medical Affairs data generation activities and ensure that activities are appropriately reflected in our financial systems.

Operations

• Assess and define staff training / mindset needs.
• Ensure medical excellence by coordinating medical processes.
• Adoption of harmonized ways of working across department.
• Collaborate with RE & IMACE, excellence teams.

Metrics

Input Indicators (what the Medical Governance, Evidence & Operations Lead prepares or brings into their work)

• Completion of all mandatory internal training required for the role.
• Stewardship of medical pillar plan of action.

Process Indicators (how the Medical Governance, Evidence & Operations Lead performs their work):

• Timely review and compliant approval of evidence generation and governance processes, workflows and activities.
• Timely completion, approval and quality oversight of all required people-management processes for direct reports (e.g., objective setting, performance reviews, development plans).

Output Indicators (what the Medical Governance, Evidence & Operations Lead directly delivers)

• Delivery of the evidence-generation deliverables according to timelines.
• Monitoring and deployment of corrective actions toward department compliance with all ERC, quality, regulatory and legal requirements.

Outcome Indicators (effects achieved through the Medical Governance, Evidence & Operations Lead’s outputs)

• RWE and evidence-generation quality, demonstrated by rigor, timely delivery and utilization in decision-making.
• Increased cross-functional alignment in development activities with internal constituents (SSO, CRMA, V&A).
• Reduction in number and severity of process and policy deviations and audit findings across all department activities.

Impact Indicators (contribution to Novartis, the healthcare system, and patients)

• Evidence generated contributes directly to reimbursement success, clinical decision-making and improved patient access.
• Strengthened scientific reputation of Novartis through publications and high-quality scientific engagement.
• Audit readiness and sustained compliance performance across Medical Affairs.

Ideal Background

Education:

• University degree in Science, Pharmacy or Health Sciences (or equivalent).
• Additional pharmaceutical medicine or clinical research qualifications desirable

Languages:

• Portuguese
• English

Experiences:

• 4-7 years of experience working in medical affairs functions
• Track record in designing, implementing, and harmonizing medical processes
• Proven ability to drive continuous process improvement, SOP updates, and operational standardization
• Experience with Excellence programs, including capability building, tracking of KPIs, and adoption of harmonized ways of working
• Experience in planning, executing, or overseeing observational studies, RWE programs, or local clinical studies, including vendor management

Functional Capabilities:

• Strong understanding of evidence planning, study start up processes, timelines, and budget oversight
• Experience with audit readiness, managing audit findings, and implementing corrective action plans
• Strong analytical skills with the ability to interpret evidence, evaluate process performance, and make data driven decisions

Leadership Capabilities & Mindset:

• Proven ability to lead cross functional teams without direct authority and influence stakeholders across Medical, Regulatory, Legal, PV, EE, and commercial interfaces
• Demonstrated ability to work with regional/international teams and act as point of contact for governance and evidence matters
• Strong communication skills with the ability to simplify complex medical and governance topics.
• Rigorous process stewardship, following internal procedures precisely, maintaining high documentation standards and proactively addressing gaps.