Labeling Operations Manager, Associate Consultant

Job Summary 

The Labeling Operations Manager (LOM), Associate provides operational support for the initial creation and relevant updates to labeling documents, including Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents. 

The LOM, Associate will be knowledgeable of labeling guidance and policies related to technical and formatting requirements, such as the QRD template and PLR format, and will raise awareness of important factors to consider when revising the label. 

The LOM, Associate provides project management to the Labeling Team throughout the labeling review and approval process through notification to stakeholders, ensuring that documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets, ensuring Labeling Teams are aware of review and approval timelines, and following up with team members so deliverables remain on target for internal and external deadlines. 

Job Responsibilities 

Support the review and delivery of labeling documents and their associated Patient Labeling Documents. The LO