Summary
About the Role
Major accountabilities:
- Review and assess local country labels to identify deviations from the core labeling and propose topics for further cross-functional assessment during the periodic core labeling review process -Contribute to DRA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products.
- Contribute to the creation of high quality documents supporting changes with internal and/or external experts including the preparation of responses to labeling related Health Authority queries -Ensure that key country label proposals which deviate from a proposed CDS or CDS amendment/update (e.g., US PI, EU SmPC) are brought to the attention -A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
- Networks with senior internal and external personnel in own area of expertise.
- 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
Minimum Requirements:
Work Experience:
- Cross Cultural Experience.
- People Challenges.
- Functional Breadth.
- Project Management.
- Collaborating across boundaries.
Skills:
- Cross-Functional Teams.
- Detail Oriented.
- Labeling Documentation.
- Labeling Regulations.
- Operational Excellence.
- Regulatory Compliance.
- Safety.
Languages :
- English.
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