Portfolio

If I had not been blessed with the teams of collaborative congenital heart specialists, I would not be here today. Ask me for details.

 I have been a technical writer in a fast-paced, high-stress environment utilizing electronic healthcare record systems for over 25 years. Some of my many responsibilities have been to write/edit, review, and publish documents. 

Experienced with IT procurement, technology, pharmaceutical and medical data information.

I have trained large (200 employees) and small groups (1 - 20) on MS Word, Excel, Adobe Pro and Pagemaker. I have given years of training classes on Agile Project development software. 

While I was at Immunomedics they had TrackWise digital QMS software installed especially for Manufacturing and for the entire company (450). I gave training classes to the whole company on Trackwise, implementing released documentation. I trained the management team on updating and revising SOPs for company-wide implementation.

 I have written many IT user manuals, training guides, and other types of documents for software development (document examples attached), and project management examples. I have written and revised software/hardware changes and other types of technology information for implementation. I have written regulatory submissions for BLAs, MDAs, MAAs FDA approvals also included resubmissions. I have written software requirements specifications, software development life cycle SOPs, test documents, test reports/ traceability matrix, a formal test plan, test results and software reports. I have written Software release packages for developer and tester tools/checklists, cGxP software retirement plans and summary reports. Detailed design specifications, and risk assessments. 

I have compiled code freeze memos and Best Practices Maintenance and Support Services Organization's (MSSO), recommendations for implementation and User Manuals. I have designed VISIO document presentations and for a complete software network and an execution rollout plan. 

I appreciate working with or without assistance while providing leadership to others and I manage highly complex documentation.  

I am known for clear/concise communications, tracking and coordinating deliverables, delivering training classes/implementing installation guides. I have created multiple types of matrices for training, testing, quality assurance (QA), quality management systems (QMS), contingency operations, reports, presentations, and SOPs.

Please see a select few of my documents below.