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Technical Writer Medical

Roy, Utah, United States
January 08, 2018

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**** * **** * ***, UT *****

Cell: 801-***-****


Successful background in medical and technical writing for FDA-regulated pharmaceutical, dietary supplement, and medical device industries that includes ISO 9001/13485 and/or cGMP/cGLP, 21 CFR 110, 21 CFR 111, and related regulations. Previous internal and external auditing experience. Productive, efficient and attentive contributor to collaborative efforts; embodiment of integrity and loyalty, successfully delivered multiple/concurrent projects under the tightest deadlines, and within existing budget constraints. Seasoned and resourceful Senior Editor/Technical Writing/Documentation Quality Assurance professional with prior Secret Clearance, recent DOD TCTO experience, including Air Force Technical Order System (ATOS) and Weapons Systems requirements, Military Specifications and Standards; specifically, MIL-STD-38784, MIL-PRF-38807, MIL-PRF5096, MIL-PRF-38804, MIL-DTL-87929, TO 00-5-1.


Freelance Technical Writer – Roy, UT December 2016 to Present

Freelance expertise includes creating engaging and though-provoking concepts and marketing products by developing and implementing marketing and advertising campaigns; tracking sales data; maintaining promotional materials inventory; planning meetings and trade shows; maintaining databases; preparing reports,.generating compelling and persuasive internal/external content for corporations, company websites, blogs and marketing campaigns, authoring short-term/contract technical writing assignments; including engineering reports, equipment operation manuals, SOPs, user guides and complete documentation libraries while seeking a full-time career position.

Knowledge Manager/Instructional Designer- DealerTrack – South Jordan, UT Feb 2016 to December 2016

Facilitated learners in acquiring knowledge, skills and competencies in an effective and engaging manner by creating

learning activities and compelling course content that enhanced retention and information transfer. Stated instructional end goals and created corresponding content. Visualized instructional graphics, the user interface and the finished product. Conducted instructional research and analysis on learners and contexts. Applied tested instructional design theories, practice and methods to exercises and activities that enhanced the learning process. Created supporting material/media (audio, video, simulations, role plays, games etc.) Determined the criteria used to grade learner’s performance and develop assessment instruments. Maintained project documentation and course folders. Used analytics to identify content improvement opportunities related to SEO. Responded to client ratings, feedback, and queries to improve the Self-Service Portal content.

Senior Editor - Booz Allen Hamilton Engineering Services – Clearfield, UT July 2012 to June 2015

Reviewed contractor provided technical data/manuals for modification to update or correct language and configurations of existing related AF weapon systems technical data. Developed, authored and edited material for U.S. Air Force Technical Orders (TOs) per ATOS requirements including revisions and rewrites, time compliant technical orders (TCTOs) utilizing Configuration Management tools, Adobe Acrobat Professional and ArborText EPIC Editor SGML tagging software and Adobe Creative Suite programs to annotate and correct existing technical documentation prior to transformation into digitized formats for electronic and hard copy utilization and retention into vendor contracts, reports, instruction manuals, test plans and other technical publications relevant to engineering or related technical disciplines.

Owner/Senior Freelance Technical Writer - Digital Data Solutions, LLC – Roy, UT January 2006 to July 2012

Broad expertise spans medical writing, medical device doxumentation, authoring white papers, biotechnology/pharmaceutical reports, software quality assurance, and product management/support. Ensured employee health and safety was the number one goal by encouraging staff to follow policies, processes, and always work in a safe manner. While in sole charge of the technical publications department, I successfully instituted a production database and documentation tracking methods, which yielded a time and cost reduction of over 30%; greatly improving document technical content and quality. Some of my clients included REDGEAR/TaxWorks (an H&R Block subsidiary), BD Medical, ICU Medical, Honeywell Aerospace, GE Healthcare and Utah Transit Authority.

Dialyzer R & D Senior Lab Technician - Fresenius Medical Care, Inc. – Ogden, UT February 1993 to January 2006

Medical device documentation and medical writing expertise included training an supervising a production team of eight (8) direct reports to achieve plant and business objectives by creating a self-directed team environment. Served as single point of contact for Laboratory Policies and Procedures to ensure alignment with Corporate Quality requirements and FDA/Code of Federal Regulations (CFR) guidelines for analytical testing and manufacturing quality standards regarding release of finished product. Addressed customer complaint investigations, quality events, and compliance investigations. Created policies specific to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.. Maintained FDA, ISO, TUV and CE approved documentation and conducted internal audits of Dialyzer R & D Laboratory Standard Operating Procedures (SOPs) and Test Methods (TMs) for accuracy, completeness and Quality Systems compliance including compiling accurate and timely completion of maintenance/preventive maintenance and associated documentation requirements of three testing laboratories and associated manufacturing equipment.


B.A. in English Studies Columbia Pacific University – San Rafael, CA October 1984 to June 1987

A.S. in Clinical Laboratory Science Columbia Pacific University – San Rafael, CA October 1984 to April 1985


Adobe Creative Suite/Photoshop, Adobe Pro X/XI, ArborText Epic Editor (XML, SGML), Author-it, Captivate, InDesign, Madcap Flare, MS Office Suites 1998 through 2013 (Word, Outlook, Power Point, Excel, Access), Framemaker, Robohelp, SQL, SAP, WordPress & Search Engine Optimization (SEO), Digital Marketing, Data Analysis, SharePoint Designer, Internal and External Compliance Audits, Laboratory instruments and equipment including UV/VIS, Flame Photometer, ELISA, Beckman Coulter Chemistry Analyzer and other instrumentation for use in analytical chemistry

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