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 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.

The LOM, will provide operational support for project tasks including:

• Generate necessary renditions in GDMS (e. g. , clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.
• Facilitate workflow through corporate document repository, e. g. , GDMS.
• Finalize documents post QC (including update of GDMS document properties such as entry of PfLEET2 number, update of document title, update CDS cover page etc. ).

• Manage the document status in GDMS and notify internal stakeholders of the availability of labeling documents.
• Order SPL for USPIs, check and upload to GDMS upon receipt, notify internal stakeholders of its availability (e. g. , Regulatory, Drug Listing).
• Responsible for ensuring compliance to Company s submission standards, policies and procedures. Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained.

Work Location Assignment:Flexible

Work Location Assignment: Flexible

Regulatory Affairs

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