Lead the integrated RWE planning and implementation of the RWE strategies at a country level and develop a robust evidence package.
Drive cross-functional collaboration to identify data/evidence gaps and contribute to the timely reimbursement approvals, contract reimbursement renegotiations, and value proposition of Novartis brands.
Partner with internal and external stakeholders on evidence generation and value confirmation to ensure broad and sustainable access to Novartis marketed brands and future pipeline assets.
Support the development of a local RWE strategy and vision.
About the Role Major accountabilities:
Assess evidence data gaps and build evidence generation plans for Novartis marketed brands and future pipeline assets.
Analyze the local RWE landscape together with the local cross-functional team and Region/Global RWE team. Identify potential gaps, anticipate potential access challenges, and needs for the next 1-3 years, and set up a plan to meet those needs.
Align with Early Value Access Lead and Medical New Products Lead the local RWE generation plan within the launch plans and the clinical trial prioritization plan for the asset brands.
Understand the evidence needs and make recommendations on fit-for-purpose data and analytics solutions.
Responsible for the tactical execution of RWE strategy and plans for Novartis products.
Work with external customers to execute applicable projects.
Conduct routine literature reviews in related therapeutic areas to understand Novartis product and comparator status.
Provide input to global/region regarding data generation for the pipeline.
Build experience in evidence generation methodologies and their processes at Novartis and its legal and regulatory framework.
Partner with cross-functional teams in the development of evidence to support reimbursement dossiers and formulary listing.
Lead and coordinate activities for the publication (e.g., papers, congress presentations) of the evidence generated and communicate this evidence with external stakeholders.
Develop and support RWE project management with high standards of operational excellence.
Network effectively across Novartis and wider forums to identify opportunities for collaboration and to identify and leverage best practices across the function.
Lead the RWE capability building at a local level.
Interact with others in a positive and constructive way, being open to diversity and aligned with corporate guidelines, to guarantee Novartis has a working environment free from all forms of discrimination and harassment, as well as contributing to a positive and inclusive working environment.
Work within Integrity and Compliance policies and ensure those around him/her do the same, complying with job Excellence Standards to contribute to the alignment with Novartis Global procedures and objectives.
Key performance indicators:
Quality and timeliness of evidence plan deliverables
Publications and congress presentations
Readiness & Quality of RWE strategy
Feedback from internal and external stakeholders
Minimum Requirements:
At least 3 years of experience in technical expertise and research methodological understanding in academic or pharmaceutical industry.
Deep understanding and experience in RWE projects.
Technical expertise and research methodological understanding to include statistical analysis, clinical studies, patient surveys, observational/epidemiologic research, and health technology or other outcome assessment.
Knowledge of both scientific and operational aspects of clinical drug development in all phases, including post-marketing and RWE.
Skills:
Good understanding of drug development, market access process.
Project Management.
Data analysis & critical thinking.
Expertise in clinical investigation methodology, epidemiology, and biostatistics.
Languages:
Portuguese
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