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
Job Title
EU Labeling