Recent Work Experience
Technical Writer Consultant at NASCO; GeBBS;
100% Remote: Sept 2011 to Dec 2012; March 2013 to Dec 2014; July 2016 to Dec 2016; June 2017 to Nov 2021
- Analyzed user stories, software specifications, and business requirements to develop, write, and edit end-user documents
- Facilitated content review cycles with SMEs to verify user guides were technically accurate and consistent with internal style guide, document templates, and Corporate branding standards
- Participated in Agile development process
- Coordinated publication life cycle to align with sprint development to ensure the timely publication of end-user documents
- Created training materials to align with user guide content and delivered live training to support Plan implementation of NASCO-developed applications
Medical Editor Consultant; Almedia Technologies, Inc.; 100% Remote: Sept 2016 to Oct 2021
Omeros Corporation, Kite Pharma
- Edited and proofed content of Regulatory submission documents, including Clinical Trial Protocols, Safety Narratives, and CMC non-clinical modules, to ensure grammatical correctness and adherence to style and formatting standards outlined in Corporate Style Guide
- Supported BLA submissions to FDA
- Authored and maintained versions of Regulatory Style Guide
Senior Technical Writer Consultant at Amgen; SMCI; 100% Remote: Oct 2012 to March 2018
- Authored, revised, and edited controlled Requirements documents to verify grammatical accuracy, readability, and consistency with Corporate Style Guide, Style Manual for Regulatory Submissions, and controlled document templates
- Interviewed cross-functional RandD SMEs to analyze existing business processes and documentation to identify opportunities for process improvement
- Managed document workflows to capture SME reviews, comments dispositions, and approvals using EDMQ controlled document repository
- Collaborated with IS Business Analyst and System Business Owner to support implementation of RandD Corrective Action Preventive Action (CAPA) System
- Created MSProject timelines to execute milestones and project deliverables within approval workflow life cycles
Senior Technical Writer; Medtronic Diabetes; Aug 2010 to Oct 2012
- Analyzed, developed, wrote, and edited device user guides, instructions for use, and HelpLine scripts for diabetes medical devices regulated by FDA
- Wrote, edited, and maintained content in Vasont content management system (CMS), FrameMaker, and InDesign applications
- Reviewed and critically analyzed technical manuals, engineering illustrations, and schematics; interviewed SMEs, including product developers, software engineers, clinical research managers, and Regulatory Affairs personnel; and investigated prototype hardware and software to develop and write software online help and installation guides
- Collaborated with RandD, Regulatory Affairs, and Legal to ensure compliance with FDA regulations, legal requirements, and Corporate marketing branding standards
- Organized and facilitated quality review boards of content based on established review processes before submission of end-user documents to Regulatory Agencies or for commercialization
Senior Marketing Technical Writer; Micron Technology, Incorporated; Nov 2006 to Dec 2012
- Wrote, edited, and published all customer-facing technical documents, including data sheets and illustrations, in XML-based CMS environment
- Wrote and edited all client-facing marketing collateral, including corporate web site content and product brochures
- Facilitated technical documentation reviews and collaborated with SMEs to publish technical marketing collateral and illustrations
- Collaborated with business unit product and marketing managers to deliver marketing collateral in conjunction with product campaign strategies
- Maintained document project schedules
- Maintained writing group SOPs, style guide, and team SharePoint web site
Medical Marketing Writer Consultant; St. Jude Medical; Oct 2009 to Feb 2010
- Designed, wrote, and edited all customer-facing medical marketing collateral to support sales of medical devices
- Adhered to applicable FDA regulations and company SOPs to conduct medical content reviews with Regulatory Affairs, in-house medical physician advisors, and Legal counsel
- Verified with product managers and design engineers that all technical content and product specifications were technically accurate
- Collaborated with product managers and graphics designers to execute product launches
- Ensured medical collateral complied with corporate branding standards
Business Process Analyst; Micron Technology, Incorporated; March 2005 to Nov 2006
- Interviewed internal customers, including software engineers and product engineers, to analyze and define customer business problems and business practices
- Wrote and maintained business process documents, including vision documents, use-cases, and system specifications
- Managed the projects for developing and implementing the appropriate software application solutions for the business problems, including writing project plans and iteration plans and tracking defects and enhancement requests
- Wrote test case scenarios and then coordinated user acceptance testing for approved solutions
- Tracked defects and enhancement requests using Rational RequisitePro and organized application iterations to implement requests
- Coordinated software releases, including writing release notes and other customer communications
- Facilitated the change management process
- Created and maintained SharePoint project web sites
IS Technical Writer; Micron Technology, Incorporated; April 2000 to March 2005
- Researched, organized, and wrote software user manuals, SOPs, and intranet web content to support implementation of proprietary software applications
- Wrote and customized quick reference cards (QRCs) and FAQs for internal users of third-party applications
- Collaborated with technical team, including software engineers, to incorporate updated web help into software applications
- Wrote IT system documentation for software engineers using RUP artifacts
- Maintained writing group's SOP documentation and tools
- Designed layout and coded intranet web sites in HTML for IT customers
- Designed and administered usability tests for software programs and web sites
- Developed training materials, PowerPoint presentations, and homework assignments and then taught five 16-hour Introduction to Technical writing classes for team members
Medical Writer; Healthwise, Incorporated; July 1998 to April 2000
- Researched, reviewed and analyzed medical literature, including clinical trials, and then wrote disease-specific medical content for distribution to healthcare professionals and patients
- Facilitated medical content reviews with in-house physicians and specialist physicians and incorporated requested changes to ensure medical accuracy of the content
- Planned and coordinated medical content delivery schedules and maintained publication deadlines
- Ensured medical content complied with corporate style guide and standards
- Conducted weekly training workshops for medical writing team
- Participated with team members to develop products and content
Associate Medical Editor; Healthwise, Incorporated; March 1997 to July 1998
- Edited and proofed all medical content and medical references for grammatical errors, readability, and conformance to corporate style guide
- Coordinated peer reviews with medical writers
- Designed, wrote, and maintained corporate style guide and medical topic outlines
- Conducted weekly writing workshops for the writing team
- Performed readability analyses on medical content and information products
Computer Skills
- Document development: Adobe FrameMaker 9.0, 10.0, 11.0, 2019; InDesign CS5; Photoshop; Illustrator; and Acrobat X Pro; RoboHelp; Microsoft Office programs, including Word, PowerPoint, and Visio; EMC2 Documentum (EDM)
- Content management in XML-based systems: XMetal and Arbortext content editors; Astoria-On-Demand and Vasont databases
- Web site development: Microsoft SharePoint 2007 and 2003; SnagIt; HomeSite; PaintShop Pro; UltraEdit
- Project management: Microsoft Project; Rational ClearQuest and RequisitePro
Education
BA, English. University of San Diego, CA. Studied in Oxford, England.
Technical Communications Certificate. Mercer University, GA.
Secondary English, Idaho Teaching Credential. Boise State University, ID.
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