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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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
