Provide advice and counsel on EU MDR, device labeling and global translation process, communicating closely with impacted stakeholders.
Responsible for ensuring compliance with the SmPC & other labeling requirements for Summary of Product Characteristics (SmPC) and related patient insert and labeling (PI Annex I-III) for pharmaceutical products in Europe for assigned products.
Ensure alignment of overall key labeling statements and key messages across EU labeling documents for assigned products.
Ensure consistency of EU device and drug product labeling across assigned product lines and compliance with AbbVie policies and procedures.
Review/QC materials, author documents, meet submission timelines for assigned products including rapid response label/PI authoring and/or review.
In collaboration with other Global Labeling team members, analyze competitor labeling for products in same class to ensure Ab...
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