Labeling - OQSIE
Santa Ana, CA 92705
About the Job
6 month assignment
Ensure appropriate and necessary labeling to meet regulatory requirements, with focus on sustaining products.Key Responsibilities: Assist in the development of solutions for labeling projects, involving: legacy systems, country-specific requirements, and product performance updates in collaboration with business unit labeling managers Technical Editor for activities that establish labeling content and instructions for use labeling; including evaluating information input into system to determine necessary content for use in labeling. Follow and maintain timetables for creating new/revised content and labeling in a cost-effective manner Identify risk and may propose new alternatives to resolves critical issues Participate in process improvement projects Other incidental duties, including working with different suppliers and vendors to propose improvement opportunities, and coordinates pre-press/press proof with printing vendors, as needed. Education and Experience:Bachelor's Degree or equivalent Required And working in a medical/pharmaceutical FDA regulated industry PreferredAdditional Skills: Good computer skills including usage of MS Office Suite Excellent written and verbal communication skills and interpersonal relationship skills Able to read, comprehend, write, and speak English Moderate understanding of domestic development and implementation of labeling Basic understanding of medical and/or pharmaceutical regulations and standards Basic knowledge of medical device documentation development activities Knowledge of ECR and PDM processes Good computer skills including usage of MS Office Suite Basic problem-solving, organizational, analytical and critical thinking skills Strict attention to detail Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
Ensure appropriate and necessary labeling to meet regulatory requirements, with focus on sustaining products.Key Responsibilities: Assist in the development of solutions for labeling projects, involving: legacy systems, country-specific requirements, and product performance updates in collaboration with business unit labeling managers Technical Editor for activities that establish labeling content and instructions for use labeling; including evaluating information input into system to determine necessary content for use in labeling. Follow and maintain timetables for creating new/revised content and labeling in a cost-effective manner Identify risk and may propose new alternatives to resolves critical issues Participate in process improvement projects Other incidental duties, including working with different suppliers and vendors to propose improvement opportunities, and coordinates pre-press/press proof with printing vendors, as needed. Education and Experience:Bachelor's Degree or equivalent Required And working in a medical/pharmaceutical FDA regulated industry PreferredAdditional Skills: Good computer skills including usage of MS Office Suite Excellent written and verbal communication skills and interpersonal relationship skills Able to read, comprehend, write, and speak English Moderate understanding of domestic development and implementation of labeling Basic understanding of medical and/or pharmaceutical regulations and standards Basic knowledge of medical device documentation development activities Knowledge of ECR and PDM processes Good computer skills including usage of MS Office Suite Basic problem-solving, organizational, analytical and critical thinking skills Strict attention to detail Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
Source : OQSIE
