Writing Services....
Technical Writing and Editing Services
My primary goal for any project is to empower customers and users with consistent, quality and usable documentation.
- Work with subject matter experts to gather and document technical requirements.
- Conduct customer/user interviews using checklists and questionnaires to ensure documentation will be usable by its target audience.
- Plan and conduct usability reviews to ensure excellence in customer experience and facilitate usability testing.
- Develop standards and style guides to improve and provide consistent, professional documentation.
- Design, write and edit usable technical and/or procedural manuals, online help, web content, general business materials, training documentation.
- Provide methods to communicate feedback and changes to all published materials.
Regulatory and Compliance Documentation
My primary goal for technical writing projects in regulated organizations is to produce documentation in compliance with federal quality policies and standards.
- Develop systems documentation in accordance with 21 CFR Part 11/ Computer Systems Validation (CSV)/ GxP (Good Clinical/ Manufacturing/ Laboratory Practice) policies.
- Create Systems Development Life Cycle (SDLC) documentation proving testability of requirements and design and, therefore, validating the system's intended use.
- Produce right-sized and risk-based documentation for COTS and internally customized applications where applicable.
- Gather information from written materials and subject matter experts to produce Standard Operating Procedures (SOPs) and Installation and Operational Qualifications (IQOQs) /Installation and Verification Instructions (IVIs).
- Use my extensive IT experience to assist in projects that establish, document, and test financial controls as directed by Section 404 of the Sarbanes-Oxley Act.
- Gather information for, organize and write comprehensive Standard Operating Procedures (SOPs) to meet and exceed Sarbanes-Oxley (SOX) requirements.
- Research and organize medical drug and device pre-market submission (PMA, 510k) packages for FDA approval.
Grant Proposal Writing Services
My primary goal for any grant proposal writing project is to focus on exhaustive research to provide targeted content for a winning proposal.
- Research geographic, statistical, fiscal and historical data as dictated by submission requirements.
- Organize and develop content as required by submission guidelines.
- Create a yearly schedule of application deadlines to assist in planning and resource allocation.
Miscellaneous Writing Services
Whatever your professional writing need, I can meet the challenge and exceed your expectations!
Software I use
Software I've used on past and present projects include:
- Microsoft Office - Word, Excel, Access, PowerPoint
- Microsoft Visio
- HTML - Notepad, HTML editors and software applications such as Dreamweaver, FrontPage, Arachnophilia
- Adobe FrameMaker for XML authoring and single source documentation
- Adobe PhotoShop (for sizing and placing graphics) and Acrobat (for creating PDF docs)
- RoboHelp
- Enterprise Architect's Unified Modeling Language for business use case diagramming