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