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Labeling Operations Manager

Pfizer


Location:
Chennai, Tamil Nadu 600 006
Date:
04/12/2018
2018-04-122018-05-13
Pfizer
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Job Details

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 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 following up with Labeling Team members throughout the process as appropriate so that deliverables remain on target to meet internal and external deadlines.







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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