Portfolio

Surviving a life-threatening congenital heart condition in early childhood gave me a deep appreciation for precision, collaboration, and the critical role of communication in healthcare. That experience laid the foundation for a 25+ year career in technical writing, specializing in electronic healthcare systems, pharmaceutical compliance, and IT documentation in fast-paced, highly regulated environments.

I have extensive experience authoring, editing, and managing technical documentation across the software development lifecycle (SDLC), quality management systems (QMS), and regulatory submissions. My work spans the development and implementation of SOPs, training manuals, compliance protocols, installation guides, and user documentation for both internal teams and external regulatory bodies. I’ve contributed to the successful submission of BLAs, NDAs, MAAs, and resubmissions, utilizing Modules 2 and 3, and have supported software validation efforts through the creation of traceability matrices, test plans, risk assessments, and release packages.

Throughout my career, I have trained and supported teams ranging from executive leadership to frontline users, conducting group sessions for over 500 employees and smaller, focused workshops on Microsoft Office tools, Adobe Acrobat Pro, Visio, and Agile/Waterfall development platforms. At companies like Immunomedics and Integra LifeSciences, I led he compliance group through refined documents and TrackWise database training, managed documentation for regulatory audits, and supported enterprise-wide SOP revisions.

As a meticulous communicator and a trusted collaborator, I bring structure and clarity to complex projects. Whether I’m managing documentation across software, medical device, or pharmaceutical landscapes, I’m committed to producing transparent, compliant, and user-friendly content that drives operational success.

Please see a select few of my documents below.