- Autonomously review of Master Label Text drafts considering regulatory requirements, standard text phrases and trial specifics - Autonomously prepare country specific label text for translation of attending countries - Autonomously review and check translated label text considering local requirements - Autonomously review and check generated print proofs and distribute proofs to countries for check and approval - Autonomously work in conjunction with CTSU Trial teams, Regulatory Affairs, Global Randomization, Medicine and label vendors to create, define and optimize labeling related tasks - Hold PLC internal and external team and pack & label vendors responsible for keeping their timeline and providing overview on the IMP pack & label milestones to the global CTSU trial team. As well as ensures appropriate and effective communication to all functions - Compile and provide completed label documentation for final release to the Release and Process Management Team - Global PLC-L Specialist provides all relevant Documents like Master Label Text, Country List, Packaging Design, STORM Document and all other country and product specific information necessary to perform this task by external vendors. PLC-L Specialist acts as main contact for vendors and countries - Contact person for all upcoming questions during the label process