What are the responsibilities and job description for the Technical Writer - Product Labeling position at bioMerieux SA?
Description
Position Summary & Responsibilities:
The Technical Writer is responsible for the development, revision, and control of product labeling deliverables (user manuals, instructions for use, and labels) in a Content Management System. This role supports reagents, accessories, and software both during the product 98development process and Lifecyle Management. During this process, the Technical Writer will write/update, review, and finalize labeling deliverable according to regulatory standards and requirements.
- Participates in cross-functional projects and communicating effectively with internal customers and management to ensure timelines and objectives are achieved.
- Executes design control processes to define labeling requirements and provide traceability.
- Understand and apply regulations as they apply to labeling.
- Responsible for consolidating and reconciling all comments from the internal reviewers; facilitating review meetings if necessary.
- Track and implement change requests, anomalies, issues, and requirements logged against labeling deliverables.
Education, Skills, & Experience:
-
Bachelor’s degree in technical writing/communication or a scientific/technical degree with 2 years’ experience in technical writing.
- High School Diploma with 6 years of technical writing experience also accepted
- Associate’s Degree with 4 years of technical writing experience also accepted
- Experience with structured authoring with XML and Component Content Management System.
- Professional experience in documentation development is essential.
- Medical devices or other regulated environment strongly recommended.
#biojobs
