Senior Global Labeling Coordinator

at  GL Healthcare Advisors

Contract: Permanent Career Opportunity
Closing Date: 26/07/24
The Senior Global Labelling Coordinator is responsible for providing advanced specialized operational support to the team in relation to the creation and maintenance of core labeling packages for development programs and marketed products, including the coordination of global labeling activities according to regulatory requirements and company standards to ensure timely and compliant regulatory submissions worldwide.

• Support the creation and maintenance of assigned labeling projects to enable worldwide regulatory submissions.
• Independently prepare and maintain the Tracking Sheets for the global regulatory dossiers related to labeling projects
• Independently coordinate the timely delivery of compliant documentation (Clinical Overviews, Non-clinical Overviews, SCE, SCS, PSUR, published literature, Expert CVs, Signature Pages, etc.) to support the regulatory labeling submissions worldwide.
• Order English translations of non-English literature as needed.
• Guide and support the team and cross-functional experts with the review of CLP and SRP documents to ensure compliance with state-of-the-art regulatory requirements and company standards, including formal QC. Independently enter and maintain current information on the labeling project in Ops system including the planned global dispatch date of CLP/SRP.
• Contribute to the planning and supervision of the Phase 1 milestones for Safety Label Changes and obtain SLC Tracking Numbers from the Compliance and Artwork Team.
• Independently prepare the Reference lists for the Core Data Sheets in compliance with current documentation standards.
• Independently exchange regulatory documents and collaborate directly with other divisions and license partners on behalf of the team according to collaboration agreements.
• Monitor the GL Mailbox for new communications from license partners and forward these to the appropriate team member. Create and maintain GL functional and product-specific labeling archives.
• Independently prepare and communicate the annual schedule of GLC and team meetings.
• Independently coordinate with CLP authors and GPTs the scheduling of topics for GLC and team review and prepare/maintain the agendas of GLC and team meetings.
• Organize the logistics of GLC and team meetings and distribute meeting invitations with pre-reads to the team members.
• Proactively ensure that CLP authors and GPTs prepare program-team-agreed draft contributions to the GLC and team meeting minutes and manage the workflow of GLC Chair review/input, finalization, distribution, and archiving of the meeting minutes.
• Independently coordinate the timely off-line GLC review of appropriate labeling changes as agreed with the GLC Chair, compile and archive the feedback received.
• Exchange planning information and documentation directly with the team members.