Associate Labeling Specialist

Job Category: Quality
Job Location: Costa Mesa - CA

Personal Attributes & Skills

  • Strong computer skills including usage of MS Office Suite
  • Excellent written and verbal communication skills and interpersonal relationship skills, with ability to drive achievement of objectives
  • Strong leadership skills with demonstrated ability to influence change
  • Able to read, comprehend, write, and speak English
  • Substantial understanding of domestic and global development and implementation of labeling
  • Substantial understanding of medical and/or pharmaceutical regulations and standards
  • Substantial knowledge of medical device documentation development activities and good documentation practices
  • Knowledge of ECR and PDM processes
  • Strong computer skills including usage of MS Office Suite
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Strong leadership skills and ability to influence change
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Work is performed independently on complex projects and/or lines of work and reviewed for accuracy and soundness

Scope & Responsibility

  • 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

Education & Experience

  • Bachelor’s Degree or equivalent required
  • 2-3 years of experience with ECR and PDM processes Preferred

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