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Global Labeling Associate (GLA)

REMOTE, PA 00000

Posted: 11/21/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 593257 Is job remote?: Yes Country: United States

Job Description

Target PR Range: 110/116/hr
*Depending on experience

Job Title: Global Labeling Associate (GLA)
Deliverables: Lead, communicate and manage tactical activities of the E2E submission and implementation phases of all labeling changes in regional and local product information and packaging to final printed packaging materials. Lead, manage and support implementation of on-going global projects with labeling impact to the foundational markets and rest of world.
Description of Services:
1. Manage, track assigned global projects with labeling impacts and monitor implementation worldwide.
2. Interface with impacted stakeholders for the maintenance and implementation of approved labeling variations into the electronic or printed package materials
3. Support GLO in providing foundational markets (Australia, Switzerland, Germany, EU and US) labels to GRA Region and ROW for NDAs, renewals, CPPs and request of labeling verification statements.
4. Collaborate and manage functional SMEs on vaccines Annual Strain Update (ASU) pre- and post- activities: Northern-ASU and Southern-ASU hemispheres.
5. Coordinate, manage and implement labeling assessment in RIMS, and Trackwise system for global labeling changes.
6. Support pre- and post-submission labeling activities for foundational markets.
7. Coordinate and manage GCC-related activities; RA Assessment and LCI collaboration with Submission Coordinator and GL Compliance
8. Ensure first time quality and compliance in all aspects of labeling with detailed packages delivered in a timely manner.
9. Manage and distribute English manuscripts for multimarket labels based on EU CP/MRP/DCP
10. Prepare and distribute EU (MRP/CP/DCP) and US Foundational labeling package to EU- and US-dependent markets.
11. Collaborate with EU-GRA Lead in coordination of labeling activities for EU CP/MRP/DCP submissions (i.e., linguistic review, national translations)
May support GLO strategy team with:
1. Review and assess ROW labels differences (DTT) from core and Foundational dependent market
2. Prepare and distribute Foundational packages to DE and CH dependent markets.
3. Management and distribution of English multi-market manuscripts based on CCDS, DE and CH to dependent markets
4. Prepare and distribute labeling packages to Toll markets / regions

*CO/NYC candidates might not be considered
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