Labeling Data Remediation Specialist
5 hours ago
Role: Labeling Data Remediation Specialist
Experience: 4–8 years
Key Responsibilities
- Review, validate, and correct product labeling data across systems.
- Identify gaps, inconsistencies, or missing data in existing labeling records.
- Remediate labeling fields to match regulatory standards and local market requirements.
- Ensure alignment between Regulatory submissions (e.g., eCTD, SPL), artwork, and product information.
- Support labeling data migration during system upgrades (e.g., Veeva Vault RIM, PLM, SAP).
- Collaborate with Regulatory, Quality, and Artwork teams to confirm accuracy.
- Maintain audit-ready documentation for all remediation activities.
Skills & Requirements
- Strong understanding of labeling components (SmPC, PIL, IFU, CCDS, artworks, pack labels).
- Experience in regulatory labeling or labeling operations.
- Familiarity with RIM/PLM systems (Veeva Vault RIM, Agile, SAP PLM, etc.).
- Ability to work with large datasets and detailed documentation.
- Strong attention to detail and compliance mindset.
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