Preparation of new and updated Core Data Sheets, EU and US Documentation: Independently manages, prepares and implements high quality regulatory labeling documents (e.g. USPI, US annotated labeling, US medication guides, US patient labels, draft US packaging components, EU SmPC, EU PIL, CCDS, annotated CCDS). Leads processes and associated systems to ensure appropriate review and governance of US, EU and global Company Core Data Sheet documents. Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as point of contact for cross-functional teams on RA labeling issues.
Ensure Compliance with Core Data Sheets/Label Changes: Provides labeling development strategic plan and has broad oversight for Core Data Sheets/label changes. Manages labeling team review of US and local country labeling deviations from CCDS; reviews and approves CCDS/labeling agreements for licensing partners.
Ensure Compliance with Health Authority Labeling Regulations and Guidances and with DSI labeling processes: Demonstrates expert knowledge of labeling guidances. Manages compliance with labeling regulations and guidelines and with DSI processes for reviewing package inserts, cartons and labels for compliance with regulations with regard to both content and format. Ensures inserts, cartons and labels of marketed products comply with current guidelines as needed.
Collaboration on Global Labeling Projects: Collaborates with other members of Global Labeling team to balance workload and share expertise as dictated by filing and approval timelines across the product portfolio. Participates in labeling process development or updates.
Please note: this position is not for labeling artwork development or management.
Experience with new product labeling development and approval, including US, EU and CCDS.
Ability to manage multi-functional teams and drive consensus.
Deep experience with labeling content development as well as compliance and quality.
Must be able to meet business and health authority mandated timelines.
Must be able to function independently but maintain frequent and timely communication with team members and management.
5-9 years of labeling experience preferred.
Bachelors degree in scientific discipline preferred. Masters degree preferred.
Sthree US is acting as an Employment Business in relation to this vacancy.
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Job ID: RE-33563734
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