The Labeling Operations Manager (LOM) 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, Manager can manage a large volume of projects which can be highly complex.



The LOM 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 LOM will be responsible for creating xml formatted documents to generate content of labeling SPL.



The LOM provides project management to the Labeling Team throughout the labeling review and approval process through notification to stakeholders 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.



Education/Experience

· Bachelor's degree in a science or life sciences preferred

· A background showcasing extensive experience in a regulated environment

· Pharmaceutical labeling experience required.


Work Location Assignment: Walton Oaks, with flexible working options