Associate Labeling Specialist
April 6, 2021
|By Sanjay Kucheria
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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