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)
Key performance indicators:
Adherence to Novartis policy and guidelines -Project & stakeholder feedback
