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 acceptedAssociate’s Degree with 4+ years of technical writing experience also acceptedExperience 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
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