Company description:
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. Were looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
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 is capable of managing 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 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 follo...