What are the responsibilities and job description for the Technical Writer - Product Labeling position at bioMerieux Inc.?
Location: Hazelwood, MO, United States
Position Type: Unfixed Term
Job Function: Manufacturing
A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.
In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.
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.
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BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).