•Review the English versions of all new and updated National Product Information documentation and compare them to source product documents (Core Data Sheets or similar reference documents) and Novartis guidelines. Identify differences and collect source documentation to justify (when appropriate) the differences observed. Maintain database of approved differences.
•Proof read Core Data Sheets and key National Product Information (English language text) prior to submission to the Health Authorities
•Perform a quality check of annotated labels, ensuring compliance to source documentation (e.g. Clinical Summary or clinical study reports if a Clinical Summary is not available).
•If product artwork is drafted in English or another language in which the associate has total fluency, proof read, and analyze compliance of the new and updated product label artwork as compared to the National Product Information.
•Assist RA Product Managers in drafting text for Core Data Sheets and for national labels in key markets (e.g. US and EU).
•Participate in the Global Labelling Committee meetings as required. This committee consists of senior level staff (Director level and above) from multiple departments within Novartis Vaccines.
•Participate in working teams under the direct guidance of the supervisor and as deemed appropriate by the supervisor, working with other groups within the organization, identifying regulatory issues and opportunities and assembling information required to resolve issues.
•Supervise one junior level associate in the Regulatory Affairs department. |
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•Total fluency in written and spoken English is mandatory. Fluency in German, Italian, Spanish or other languages is beneficial.
•Quality focus and exactitude are mandatory attributes for success in this role.
•Scientific training in pharmaceutical, biological or biotechnology areas. Minimal academic training: BA/BS in scientific or medical discipline. Advanced degree preferred.
•6 to 8 years experience (minimum) within Vaccine/Biotechnology/Pharmaceutical Regulatory Affairs, preferably with extensive auditing or technical writing expertise.
•Working knowledge of electronic tools/systems, Expert level use of Microsoft WORD
•Strong communication skills with proven success working in a global team.
•Strong sense of urgency and adherence to timelines. |
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