What are the responsibilities and job description for the Label Generation and Compliance Expert position at Kelly Science, Engineering, Technology & Telecom?
Job Summary
">We are seeking a highly skilled Label Generation and Compliance Expert to join our team at Kelly Science, Engineering, Technology & Telecom. In this role, you will be responsible for ensuring all clinical supplies and associated documentation are processed according to GMPs/GDP's and appropriate safety requirements.
">About the Role
">This is an exciting opportunity to work in a dynamic environment where you will be responsible for coordinating translation requests, generating clinical label proofs with CLPG, and liaising with country-level clinical operations personnel or regulatory affairs.
">Responsibilities
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- Coordinate translation requests and ensure accurate label generation. ">
- Generate clinical label proofs with CLPG and verify correct labels are produced according to cGMPs. ">
- Liaise with country-level clinical operations personnel or regulatory affairs to address questions, revise translations, update regulatory requirements, etc. ">
- Maintain label translations library and interpret clinical study design and clinical supply strategy (CSS). ">
- Design and verify label models, and coordinate MLBL manufacturing with vendors. ">
Requirements
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- Bachelor's degree in a relevant field or equivalent experience. ">
- Working knowledge of Packaging Operations and related work centers. ">
- Strong attention to detail, strong verbal and written communication skills, and strong organizational skills. ">
- Ability to prioritize and multi-task, and knowledge of general computer skills (i.e., MS Word, Excel, PowerPoint). ">
About Us
">Kelly Science, Engineering, Technology & Telecom is a leading provider of specialized staffing solutions. We help our clients achieve their business goals by providing high-quality talent across various industries.
