EU Labeling

Description

• Author / update labelling documents such as EU SmPC, regional PIs.
• Act as the first layer of quality check for draft labelling documents. Ad hoc EU Proofing of Baseline English, QRD Formatting Review.
• Provide proofreading support for labelling documents against Health Authority regulations, ensuring timelines are met, the submissions are agency compliant and of quality.
• Formatting, technical / scientific content check, alignment to regional templates, client reference guide regular monitoring and tracking of Innovator labels.
• Review labels for compliance with applicable regulations and policies.
• Linguistic review of EU SmPC revisions and Support EU readability testing
• Review / QC labelling sections of PSMF.
• EDMS management of approved EU SmPC revisions and EU Product Information Updates (Administrative Multilingual Updates)
• Manage EU Labels which includes EU Linguistic QC (coordination and support).
• Responsible for coordinating Labeling workflow activities and Labeling Change Controls support.
• Track and update RIM systems related to specific labelling events, e.g., uploading relevant documents, communication with relevant stakeholders, updating important dates in the systems, sending notifications to relevant stakeholders.
• Provide post approval support of CCDS changes and updates (e.g., changes to products, exceptions, deferrals etc.).
• Manage Labelling folders on Freyr / Client systems