Job Description Summary

Job Description

Job Dimensions

Number of associates:

Single contributor role.

Financial responsibility:

Oversees study budgets and vendor contracts associated with local RWE activities. Contributes to efficient resource use within Medical Affairs evidence generation.

Decision making:

Makes scientific and methodological decisions related to local RWE plans prioritization of evidencegeneration activities selection of data and analytics solutions and study design within established governance.

External/internal stakeholders Interface:

• Internal: Medical Affairs (TAs) Value & Access HEOR Regulatory Clinical Research Medical Evidence & Governance Execution Excellence Commercial TA Global/International/Regional RWE ERC.
• External: Academic institutions external research organizations data partners vendors scientific societies HCPs/MEs.

Impact on the organization:

Strengthens evidencebased decisionmaking supports access and reimbursement success enhances value demonstration of Novartis brands and accelerates lifecycle excellence through the systematic generation and integration of realworld evidence.

Major Accountabilities

RWE Strategy & Planning

• Assess evidence gaps and develop local RWE generation plans for marketed brands and pipeline assets.
• Analyze the local RWE landscape with crossfunctional teams and Regional/Global RWE partners anticipating data needs and access challenges within a 1 to 3year horizon.
• Align RWE plans with Early Value Access New Products and clinical trial prioritization strategies.
• Provide input to Global and Regional teams on datageneration needs for pipeline assets.

Evidence Generation & Execution

• Recommend appropriate data and analytics solutions based on scientific and methodological requirements.
• Lead the tactical execution of the RWE plan ensuring timely and highquality delivery of evidencegeneration activities.
• Collaborate with external stakeholders (academic institutions data providers CROs) to execute RWE projects in alignment with internal governance.
• Ensure strong project management operational discipline and adherence to internal processes in all RWE initiatives.

Scientific Communication & Publications

• Conduct routine literature reviews to monitor the competitive landscape and the evolving evidence base.
• Lead and coordinate publication activities for RWE outputs ensuring high scientific standards and effective dissemination.
• Translate complex methodological and statistical content into clear actionable insights for internal and external stakeholders.

Crossfunctional Partnerships & Access Support

• Partner with Value & Access HEOR and Medical TAs to develop evidence supporting reimbursement dossiers formulary listings and value updates.
• Network across the organization to identify collaboration opportunities and share best practices in RWE methodology and execution.
• Lead capabilitybuilding for RWE understanding and execution at local level in collaboration with Medical Evidence & Governance and Execution Excellence.

Compliance & Governance

• Uphold Novartis ethical standards ensuring all RWE activities comply with national legislation dataprivacy requirements internal policies and functional excellence standards.
• Maintain accurate documentation and reporting of RWE activities supporting audit readiness and continuous process improvement.

Metrics

Input Indicators (what the RWE Lead prepares or brings into their work)

• Completion of all mandatory internal trainings required for the role.

Process Indicators (how the RWE Lead performs their work):

• Timely and compliant execution of RWE activities according to internal governance dataprivacy and methodological standards.

Output Indicators (what the RWE Lead directly delivers)

• Delivery of planned RWE evidencegeneration activities (e.g. analyses studies datasets publications) according to the annual RWE plan.

Outcome Indicators (effects achieved through the RWE Leads outputs)

• Demonstrated integration of RWE insights into reimbursement dossiers access strategies or crossfunctional decisionmaking processes.

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

• Contribution of RWE outputs to sustained or improved patient access reimbursement success and contract renegotiation outcomes;
• Reinforced scientific reputation of Novartis through highquality publications and stakeholder engagement.

Ideal Background

Education:

• University degree in Science Epidemiology Biostatistics Pharmacy or related discipline with a solid technical background.
• Advanced degree (MSc PhD) in Epidemiology Biostatistics Public Health or related field desirable.

Languages:

• Portuguese
• English

Experiences:

• At least 3 years of experience in RWE epidemiology health outcomes or related scientific roles in academia or industry.
• Deep understanding of RWE methodologies including observational research epidemiologic study design statistical techniques and outcomes assessment.
• Knowledge of operational and scientific aspects of clinical development including postmarketing and RWE activities.
• Experience supporting reimbursement access or value demonstration processes is a plus.
• Experience interacting with regional/global RWE or HEOR functions is desirable.

Functional Capabilities:

• Strong analytical skills and ability to interpret and communicate complex data.
• Expertise in clinical investigation methodology epidemiology and biostatistics.
• Solid understanding of drug development and market access processes.
• Ability to design and oversee local evidence generation (RWE observational studies registry programs).
• Strong project management capability and ability to work crossfunctionally.
• Business mindset and Healthcare Systems thinking anticipating data needs and access challenges.
• Solid understanding of compliance dataprivacy regulatory requirements and governance processes.

Interpersonal Capabilities & Mindset:

• Scientific curiosity and growth mindset.
• Ability to influence without authority and engage stakeholders across functions.
• Acts with credibility and clarity of purpose to build and maintain effective and collaborative relationships.
• Collaborative crossfunctional orientation.
• Clear impactful communication; ability to simplify complex scientific and methodological concepts.
• Adaptable resilient and comfortable navigating ambiguity.
• High integrity ethical judgment and a patientcentric mindset guiding all interactions.
• Rigorous process stewardship following internal procedures precisely maintaining high documentation standards and proactively addressing gaps.

Skills Desired