Jeri – Technical Writer
Jeri, a technical writer and editor, has broad experience in the pharmaceutical industry with significant background in document control/management, writing SOPs, work instructions, process documentation and eLearning courses. She has expert knowledge of computer system validation, FDA requirements and other compliance issues. Her education includes a bachelor’s degree and certification in FDA 21 CFR Part 11.
- At a financial services company, Jeri created SOPs and other procedural documentation to ensure compliance with government regulations, allowing the organization to obtain certification to become a Federal lender of educational funding.
- At a medical device company, Jeri provided advanced technical writing and editing for a GMP-regulated environment, documenting processes and procedures for the design, engineering, validation, facility operations, production, QC/QA, and distribution of medical devices.
- At a medical device company, Jeri created training materials for CSV, SDLC, GxP, FDA 21 CFR Part 11, Sarbanes-Oxley (SOX) and audit readiness.
- At a biotech company, Jeri planned and coordinated document design and development for local, regional or transnational use (including the creation of SOPs, work instructions, project instructions and other controlled documents) that adhere to regulatory guidelines. Edited and proofread clinical documents in preparation for submission to regulatory agencies.
- BA, Communications, University of Pennsylvania
- Certification, FDA 21 CFR Part 11
- Proficient in Pagemaker, Illustrator, Photoshop, Visio, Framemaker, RoboHelp, Dreamweaver and HTML.
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