Label Development Specialist

2 days ago


Ridgefield, United States Insight Global Full time
Job DescriptionJob Description

A large pharmaceutical client in Ridgefield, CT is looking for a Label Development Specialist to sit hybrid 2-3 days a week onsite in Ridgefield, CT. This employee will be joining the Labeling and Packaging team and will be working with other team members alongside the director and head in both Ridgefield and Germany. This candidate will be in a fast paced environment with lots of everyday changes and adjustments. They will review of Master Label Text drafts considering regulatory requirements, standard text phrases and trial specifics, prepare country specific label text for translation of attending countries, review and check translated label text considering local requirements, and review and check generated print proofs and distribute proofs to countries for check and approval. They will also work in conjunction with global Trial Teams, Regulatory Affairs, Medicine and label vendors to create, define and optimize labeling related tasks. They will hold PLM 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 trial team as well as ensures appropriate and effective communication to all functions. In addition, they will compile and provide completed label documentation for final release to the Release and Process Management Team. The 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. This candidate must be fluent in English as they will be making the labels in English. They will need to be motivated, willing to learn, willing to ask questions as well as listen to feedback, and be able to keep up in a high-paced ever changing environment. They will also need to have great communication and team work skills.



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