Labeling Operations Specialist
FortreaColombia only
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Job Overview:
The Labeling Operations Specialist (LOS) provides operational support for the initial creation and relevant updates to labeling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized
Procedures, and their associated Patient Labeling Documents. The Labeling Operations Manager, Senior Associate is capable of managing a large volume of projects, these projects can be medium to highly complex.
The LOS will be knowledgeable of labeling guidance and policies related to technical/formatting (e.g. QRD template, PLR format) and will raise awareness of important factors to consider when revising the label.