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
