Associate Labeling Specialist

Job Category: Quality

Duration: 6 months

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

To Apply

Please email resumes to careers@trinus.com to be a part of a high-growth professional services firm where you can take your career to new heights. Apply if you are even slightly curious about an opportunity to take your career to the next level.