About the position
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 development process and Lifecycle Management. During this process, the Technical Writer will write/update, review, and finalize labeling deliverables according to regulatory standards and requirements. Participates in cross-functional projects and communicates effectively with internal customers and management to ensure timelines and objectives are achieved. Executes design control processes to define labeling requirements and provide traceability. Understands and applies regulations as they apply to labeling. Responsible for consolidating and reconciling all comments from the internal reviewers; facilitating review meetings if necessary. Tracks and implements change requests, anomalies, issues, and requirements logged against labeling deliverables.
Responsibilities
- Develop, revise, and control product labeling deliverables in a Content Management System.
- Support reagents, accessories, and software during product development and Lifecycle Management.
- Write/update, review, and finalize labeling deliverables according to regulatory standards.
- Participate in cross-functional projects and communicate effectively with internal customers and management.
- Execute design control processes to define labeling requirements and provide traceability.
- Understand and apply regulations related to labeling.
- Consolidate and reconcile comments from internal reviewers and facilitate review meetings if necessary.
- Track and implement change requests, anomalies, issues, and requirements against labeling deliverables.
Requirements
- 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.
- Experience in medical devices or other regulated environments is strongly recommended.
