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Labeling Specialist

Orange County Metro Area, CA

Post Date: 04/12/2017 Job ID: JN -042017-18830
R&D Partners is hiring for a talented Labeling Specialist in Irvine or Santa Ana area.

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

Preferred Additional 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 labelling
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

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