Portfolio

 I  was blessed with a team of collaborative congenital heart specialists in 1968 or 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 systems for over 25 years. Some of my many responsibilities have been to write, edit, review, and publish documents and manuals. 

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

I have trained large (400+ employees) and small groups (1 - 20) on MS Word, Excel, Adobe Pro and Pagemaker. I have given years of training classes on Agile Waterfall Project development software. 

While I was at Immunomedics they had TrackWise digital QMS software installed for Manufacturing and the entire company (450 employees). 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 was instrumental in regulatory submissions for pharmaceuticals in Module 2 and Module 3.

 I have written many IT user manuals, training guides, and other types of documents for software development (some document examples attached scrubbed for confidentiality), and project management examples. I have updated software/hardware manuals and changes to other types of technology information for implementation and release. I wrote and submitted 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 enjoy being a team player and appreciate working with or without assistance while providing leadership to others and I have managed 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.