Summary
Overview
Work History
Education
Skills
Certification
Awards
Management Expertise
Technical Writing & Document Analyst Expertise
Technical & Medical Writing Expertise
Research Writing Expertise
IT Security Documentation Expertise
First American Credit Company
Orange County Transit District
Apollo Group, University of Phoenix
Goodwill Industries
Boeing/McDonnell Douglas Helicopter Systems
Allied Signal
Other past employment and contracts at
Timeline
Generic

Leslie Diane Watson

Simpsonville

Summary

Biomedical engineering technician And Project Management, Multimedia and Web Content Writing, Editing, Management, Technical Writing, documentation for Medical, Aerospace, Manufacturing, Product Development, Safety, Regulatory & Compliance Manager of Regulatory compliance- Blockinterop/Correlate Health Systems -2018-present USER AND POLICY GUIDES

Qualified [Desired Position] with background in crafting clear and comprehensive documentation. Proven ability to translate complex technical information into user-friendly content. Demonstrated strong research and writing skills, consistently delivering high-quality materials that meet project requirements.

Overview

17
17
years of professional experience
1
1
Certification

Work History

GGWNTV.com

Manager of Regulatory and Compliance

EGI Environmental
10.2014 - 01.2015
  • Development of regulatory, QA and Document Control departments in compliance with the EPA, and Orange County and California regulations for the cleanup and disposal services for coastal wastewater cleanup projects.

Project Manager /Technical Writer / Project Coordinator/ Team Supervision

DW Watson Doc & Design
09.2004 - 12.2014
  • Performed project management and coordination for nonprofit and profit corporations; business analysis, development and documentation of legacy and new software/hardware products; upgrades, installations and launch for the IT medical device, pharmaceutical, mechanical, consumer, aerospace, and engineering industries.
  • Documented compliance development and control, database development, data warehousing, technical training; writing and editing.
  • Performed extensive product documentation, system documentation, and writing of user guides.
  • Created policies and procedures manuals.
  • Handled customer service coordination and management.
  • Performed documentation development for operations, QA, online marketing content, and copy writing.
  • Developed user and field service manuals, both online and on paper.
  • Performed PeopleSoft library integration documentation; operational structures, practices, and institutional procedures.
  • Developed educational/training documents.
  • Completed project and product marketing materials, both online and on paper.
  • Project development, model making and prototyping, short run manufacturing
  • Chief web content writer and editor
  • Trainer – Technical writing certificate program, curriculum development, principle trainer

Technical Writer | Regulatory Specialist

Baxter Healthcare
08.2014 - 09.2014
  • Interviewed R&D subject matter experts (SMEs), such as clinical study managers and business process owners, to create business process flow diagrams. Translated process flows into SOPS, user manuals, and other requirements/standards documents to enable Amgen team members to execute corporate processes in an FDA-regulated environment.
  • Analyzed, developed, wrote, and edited device user guides, instructions for use, and Help Line scripts for all medical devices regulated by FDA.

Technical Writer

Boston Scientific
11.2013 - 01.2014
  • Researched and developed new Software User Documentation, for Inter Cardiac Ultrasound systems. Worked within FDA Guidelines to achieve and maintain QA and regulatory compliances.

Senior Research Writer

Disneyland Resorts
06.2013 - 08.2013
  • Researched Fall Protection for new construction and manufacturing safety standards
  • Supported the Safety Fall Protection Team in coordinating immediate, mid and lower levels of OSHA remediation documentation. Supported the Director of Disney Resorts, on the fall protection and Safety Stair and Platform codes and standards construction research project.

Technical Writer/Document Control/Training Coordinator

Teredyne- Laser Surgical Medical Devices
04.2013 - 06.2013
  • Documentation of QA operations for corporate move for FDA compliance
  • Maintenance of document control, and document verifications.

Technical / Medical Writer

Johnson and Johnson-Neutrogena
01.2013 - 03.2013
  • Provided: Cleaning Validation documentation, Product assessments, SOPs, Reports, ISO/cGMP protocols. I successfully developed the Cleaning Validation Documentation Tracking system for clarity, speed and ease in documenting process for all protocols. I also provided cleaning qualification supportive documents for the OTC pharmaceutical launch of Neutrogena Products.

Technical / Medical Writer

TEVA Pharmaceuticals
10.2012 - 12.2012
  • Compiled and wrote clean room procedures, SOP’s, GMP’s, process validations for product packaging, manufacturing and facility operations for new pharmaceutical FDA rating.

Technical / Medical Writer

Histogen Inc.
06.2012 - 10.2012
  • Created clinical trial SOPs for FDA submissions. Documented the clinical trial changes, (CSRs) for a new manufacturing process. Maintaining compliance, GMPs, Working with the FDA, Quality Documentation System. Stayed consistently knowledgeable of CTD/eCTD, ICH-E3, GCP, CER, CSR, protocol documentation.

Technical Writer/Analyst

St. Jude Medical Inc.
10.2011 - 12.2011
  • Medical device compliance manufacturing project, involving creation of writing standards, correction of existing manufacturing procedures, development of new procedures and compliance documentation.

Compliance and Documentation Manager

Alagin Research Inc.
01.2009 - 03.2010
  • FDA premarket approval submissions for new medical devices and therapies, hardware, software and pharmaceutical projects. Secured and managed the installation of Master Control document management software for all departments. Development of the document control department, and management. Supervised the compliance process guidelines, instructions, procedures documentation.

Technical Writer

Adams Rite Aerospace
09.2008 - 12.2008
  • QM Test Procedures for Airbus Security Cockpit doors. Compiled, revised and wrote new copy for the QM Test Procedures, ATP, and FTP process for Airbus customers’ product line. Followed customers PTS, directives, FAA, ISO 9000 required docs, and developed new documentation for two models of security cockpit doors.

Project Coordinator / Documentation Analyst / Technical Writer

Allied Signal
06.1999 - 09.1999
  • Performed project coordination; writing/editing of policies and procedures, data spec sheets, manufacturing, and R&D processes; and created online data reference manuals. Coordinated writing/editing data for analyzing; organized and compiled data to meet OSHA and EPA DO – 160 standards for corporate, state and federal compliance.
  • Documented and performed online data process mapping of ISO 9000 projects.

Technical Writer / Documentation Analyst

Boeing/McDonnell Douglas Helicopter Systems
06.1998 - 09.1998
  • Communications Division, Software documentation development, content writing and editing of the online service manual – APACHE-HELICOPTER Documented complete communications systems for onboard/online Field Service manual SDLC. DO – 160,160 D, 274

Education

Doctorate - CommunicationsMultimedia and Project Management

Master of Arts - Communications

Emerson Institute
Oakhurst, CA
01.2007

Bachelor of Arts - Electronics Engineering Technology

Wentworth Institute
Boston, MA
01.2004

Skills

  • MS Suite: MS Project 2024
  • Comptia project management
  • SharePoint, Word 2024, Outlook, Visio, Excel, PowerPoint
  • Acrobat,HTML5, cc
  • Preferred Affiliate Master Control, document management system
  • Regulatory and Quality Compliance Experience and Knowledge:
  • JCOHA, HAZ MAT, ISO - 9000/9001, NDA, , FDA 510k, CFR-820, CAPA, cGMP qualifications and compliances
  • OSHA safety, security and disaster preparedness CTD/eCTD, ICH-E3, GCP, CER, CSR, protocols, Agile
  • Professional publication subscriptions: FDA Daily newsletter, LAB Compliance Newsletter, Women Tech Educators, ASTD, AMWA, BMES
  • Programming fundamentals
  • Biomedical device engineering, product development and service
  • Multimedia project development and production

Certification

  • ISO 9000/9001-2008
  • FDA CFR-820, cGMP quality training
  • FDA 510k submissions procedures
  • Foundations of Programing
  • Quality Control Procedures
  • Sarbanes Oxley
  • COMTIA Project Management -certificate
  • Video Production, screen writing and story boarding
  • Emergency Medical Technician certification training - USAFR
  • Basic telecommunications and state emergency preparation
  • Network Security Fundamentals
  • Database fundamentals, Oracle/SQL- DBA design fundamentals
  • Web Design HTML5 and CSS3
  • Adobe Captivate 9: Beyond the Essentials
  • MS Project 2024
  • Excel 2024
  • Taxonomy
  • Documentum - Document management and control systems training
  • Xerox International documentation standards and technical writing/editing
  • Manufacturing, model making and prototypes
  • Sales and Marketing Principles
  • Photo Journalism

Awards

Governor of California’s Medal for Outstanding Leadership - CANG/USAFR, Commendation for Leadership - Commandant, March AFB, US Coast Guard Auxiliary-Officer, FSO Managing Editor of # 68 Flotilla newsletters, Society for Technical Communicators - National Competition – Former International judge, Biomedical Engineering Society, AMWA – American Medical Writers Association, OC Regulatory Association

Management Expertise

  • Supervised the compliance process guidelines, instructions, procedures documentation for FDA premarket approval submissions.
  • Performed project management and coordination for nonprofit and profit corporations; business analysis, development and documentation of legacy and new software/hardware products; upgrades, installations and launch for the IT medical device, pharmaceutical, mechanical, consumer, aerospace, and engineering industries.
  • Coordinated the writing/editing of data for analyzing; organized and compiled data to meet OSHA and EPA DO - 160 standards for corporate, state and federal compliance.
  • Documented and performed online data process mapping of ISO 9000 projects.

Technical Writing & Document Analyst Expertise

  • Developed and maintained QA Operations and Documentation for corporate downsize operation and move for FDA compliance, which included Analysis and development of raw data into compliant document control content.
  • Email Marketing: Produced 25%+ of online revenue through strategic management of email marketing channel.
  • Secured and managed the installation of Master Control document management software for all departments.
  • Performed PeopleSoft library integration documentation; operational structures, practices, and institutional procedures.

Technical & Medical Writing Expertise

  • Researched, analyzed, and compiled blood plasma product documentation for global submissions for compliance to the eCTD FDA online system.
  • Researched, Analyzed, and Developed new Software User Documentation, for Intra-Cardiac Ultrasound Systems.
  • Provided cleaning qualification supportive documents for the OTC pharmaceutical launch of Neutrogena Products.
  • Successfully analyzed testing, documentation, and developed the Cleaning Validation Documentation Tracking System for clarity, speed and ease in documenting process for all protocols.
  • Created clinical trial SOPs for FDA submissions. Documented the clinical trial changes, (CSRs) for a new manufacturing process.
  • Revised electrical motor conversion process for commercial vehicles, and all required compliance documentation

Research Writing Expertise

  • Researched and analyzed the Fall Protection standards for development of new and existing Disney construction and manufacturing safety standards.
  • Supported the” Fall Safety Protection Team” in analyzing, coordinating immediate, mid and lower levels of the OSHA remediation documentation.
  • Supported the Director of Disney Resorts, on the “Fall Protection” and “Safety Stair and Platform” codes and standards construction research project.
  • Updated and maintained all appropriate documentation on “Fall Protection” for all Disney Rides, and to comply with existing OSHA standards, creating compliance for all Disney Resort Rides to an “In-House” state of compliance standards.

IT Security Documentation Expertise

Content Editing and English Translation for corporate websites, blogs, technical articles, and books - present

First American Credit Company

Technical writer, Analyst, Y2K Security Documentation for mortgage credit system, SOPs, security system software documentation development.

Orange County Transit District

  • Documentation Supervisor, Analyst for OCTA (D) corporate installation and launch of new fiscal multilevel software system.
  • Documented multi departmental IT security for compliance with county requirements.
  • Created end user documents on all levels from highest level executives to garage mechanics, revised all policies and procedures. Created new SOP standards for financial software installation.

Apollo Group, University of Phoenix

  • Technical writing and intranet HR web system development.
  • Security software procedures for extensive number of new campuses to be integrated into UOP system for compliance with Federal funding and student financial aid system.
  • Authored and coordinated the documentation for PeopleSoft Financial Aid training.
  • Documented SOPS, creating templates for Software upgrades for Student Administration.
  • Performed PeopleSoft library documentation integration and revisions.
  • Documented local policies and procedures for financial aid applications and processing of Federal State, (Title 1V, Pell grants), institutional and scholarship funding.

Goodwill Industries

  • Technical writer
  • Documented the POS, and security system policies and procedures for the IT Departments Operations to secure all the POS databases at all stores locations.

Boeing/McDonnell Douglas Helicopter Systems

  • Technical Writer/ Analyst obtained Secret Security Clearance
  • Apache Helicopter - Communications Division - Software development, content writing and editing of interactive field service manual. Documented -Communications systems software and ensured all security documentation in compliance with DOD regulations. DO – 160, 160 D, 274

Allied Signal

  • Technical Writer Project Coordinator /Documentation Analys
  • Performed project coordination; writing/editing of policies and procedures, data spec sheets, manufacturing, and R&D processes; and created online data reference manuals, and security policies in compliance with NASA, Government requirement standards for US Space Station.
  • Coordinated writing/editing data for analysis. Organized and compiled data to meet OSHA and EPA DO 160 standards for corporate, state and federal compliance. Documented and performed online data process mapping of ISO 9000 projects.

Other past employment and contracts at

  • Xerox Corp, El Segundo CA.
  • Texas Instruments, Los Angeles, CA tech writer service manuals.
  • Elcint Corp, Boston, MA.
  • UCI Medical Center, Orange, CA,field service mgr
  • Biomed engineering tech.
  • Hoag Memorial Hospital, Newport Beach, CA.Biomed engineering technician
  • CA Air National Guard, Costa Mesa, CA Telecommunications tech
  • USAF Reserves, Riverside, CA, med tech
  • US Coast Guard Auxiliary, Dana Point, CA

Timeline

Manager of Regulatory and Compliance

EGI Environmental
10.2014 - 01.2015

Technical Writer | Regulatory Specialist

Baxter Healthcare
08.2014 - 09.2014

Technical Writer

Boston Scientific
11.2013 - 01.2014

Senior Research Writer

Disneyland Resorts
06.2013 - 08.2013

Technical Writer/Document Control/Training Coordinator

Teredyne- Laser Surgical Medical Devices
04.2013 - 06.2013

Technical / Medical Writer

Johnson and Johnson-Neutrogena
01.2013 - 03.2013

Technical / Medical Writer

TEVA Pharmaceuticals
10.2012 - 12.2012

Technical / Medical Writer

Histogen Inc.
06.2012 - 10.2012

Technical Writer/Analyst

St. Jude Medical Inc.
10.2011 - 12.2011

Compliance and Documentation Manager

Alagin Research Inc.
01.2009 - 03.2010

Technical Writer

Adams Rite Aerospace
09.2008 - 12.2008

Project Manager /Technical Writer / Project Coordinator/ Team Supervision

DW Watson Doc & Design
09.2004 - 12.2014

Project Coordinator / Documentation Analyst / Technical Writer

Allied Signal
06.1999 - 09.1999

Technical Writer / Documentation Analyst

Boeing/McDonnell Douglas Helicopter Systems
06.1998 - 09.1998

GGWNTV.com

Master of Arts - Communications

Emerson Institute

Bachelor of Arts - Electronics Engineering Technology

Wentworth Institute

Doctorate - CommunicationsMultimedia and Project Management

Leslie Diane Watson