About the Role
- Manages medium to small level global regulatory submission projects.
- Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
- Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
- Write, edit and /or manage the production of high quality clinical documentation (e.g. Clinical Study Reports & Summary Documents) for submission to regulatory authorities in support of marketing applications.
- Developing professional expertise, applies company policies & procedures to resolve a variety of issues.
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- Frequent internal company and external contacts.
- Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Refers to established policies & procedures for guidance.
- Contributes to some cost center goals & objectives -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
- Adherence to Novartis policy and guidelines -Project & stakeholder feedback
Work Experience:
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.
- Functional Breadth.
- Collaborating across boundaries.
- NA.
- English.
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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