Develop internal training reference materials, including repair videos and training plans.May review, edit, rewrite, and consult on the work of others prepared within functional area, other departments, or by external sources to ensure quality of deliverables (i.e., product documentation from acquisitions).Understand medical device standards and regulations and incorporate in deliverables.Adhere to corporate, quality system, and regulatory requirements.Coordinate, review, and approve deliverables in an enterprise system software keeping documentation updated with respect to changes in deliverables.Create and incorporate graphical elements for instructional purposes and accurate interpretation, including international application.Write and edit Service Procedures, Maintenance Manuals, and other accompanying documents aligning content with associated product.Interview and collect information from Subject Matter Experts (SMEs) from Service, R&D, RA, various functional areas.Develop customer facing product maintenance information according to user needs and regulatory requirements for domestic and international customers.Develop internal facing product maintenance information according to user needs for domestic and international customers.All documentation must comply with medical device requirements. Audience includes Stryker Repair, Field Service, and Customer Service Technicians and Biomedical Equipment Technicians in global markets. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.Īs the Technical Writer you will assist in the timely development and completion of comprehensive repair instructions for a variety of products. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. This role is hybrid, in Kalamazoo, MI, with the expectation to come into the office 3 days a week. $60,000.00 to $100,000.Stryker’s Instruments Division is seeking to hire a Technical Writer to support the Service Department. A2-Ai provides top of the industry benefits including 401(k) with company contributions, fully funded health insurance without employee premiums, employer funded HSA, and 20 days of paid time off.Experience with population PK/PD analysis is a plus.Įxperience in regulatory writing and knowledge of regulatory guidelines (e.g., FDA, EMA) is desirable.Excellent communication skills and ability to collaborate effectively with cross-functional teams. BS or higher in a scientific discipline (e.g., Biology, Chemistry, Pharmacology).Participate with client and A2-Ai pharmacometricians in the preparation of manuscripts for journal submissions and/or posters for presentation at professional meetings.Prepare regulatory response documents as requested.Maintain working knowledge of regulatory agency guidelines and requirements.Comply with 21CFR11 regulations to maintain an audit trail of all reported results.Coordinate activities for the quality control (QC) of results against original source documents.Facilitate the report review and approval process.Prepare analysis plans and reports (internal reports for client as well as submission-ready reports) of modeling and simulation results. The medical writer will work with pharmacometricians to prepare analysis plans, modeling and simulation reports and regulatory submission documents for our clients’ drug development programs.
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