Job Overview:
The Labeling Operations Sepecialist (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.
The LOS provides project management to the Labeling Team throughout the labeling review and approval process through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets,



ensuring that Labeling Teams are aware of the review and approval timelines and following up with Labeling Team members
throughout the process as appropriate so that deliverables remain on target to meet internal and external deadlines.
Summary of Responsibilities:
Generate necessary renditions (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.
Facilitate document workflow through corporate document repository
Finalize documents post QC
Utilize labeling tracking systems and perform system data quality checks.
Utilize text verification and proofreading tools
Notify internal stakeholders of the availability of labeling documents.
Consolidate labeling versions.
Consolidate comments from Labeling reviewers and Regulatory Authorities.
Prepare comparison tables for labeling team discussions.
Edit and format labeling documents- Ensure the document c

📌 Labelng Operations Specialist (San José)
🏢 Fortrea
📍 San José