A bit about my background and experience in regulatory medical writing and teaching...
MBA, specialization in Information Technology Management (Rivier University)
PhD, Molecular Biophysics (University of Texas Southwestern Medical Center)
BS, Chemistry (Furman University)
Supported writing for 12 INDs
Served as a clinical writer for 3 NDAs and 7 BLAs
Written countless original protocols and protocol amendments for drug studies (Phase 0-4), devices (feasibility, pivotal, and postmarketing), and combination products
Prepared meeting requests, briefing documents, and responses to requests for information from health authorities
....and MORE!
Spent several years teaching online webinars and in-person workshops for a professional training organization (clinical trial protocols, clinical study reports, Investigator Brochures, INDs, and general medical writing)
Trained a 100+ global regulatory team on using Microsoft Word templates for the creation of regulatory documents
Lead customized workshops for global teams (both online and in-person format) with hands-on learning activities
While I enjoyed bench work in graduate school, I knew I didn't want to be culturing bacteria and running gels for decades. I wanted to do something where I could make more direct of an impact. I always enjoyed writing and was the go-to editor for my laboratory colleagues and classmates throughout graduate school. After doing a short post-doc, I started applying for as many writing jobs I could find in the pharmaceutical, medical device, and biotechnology space. I finally landed a job at a large medical device company doing scientific communications. It was a unique role (which I didn't even realize at the time) where I also gained experience in writing CSRs and clinical trial protocols, along with other device-specific regulatory documents. I enjoyed the regulatory work more than the communications work so, 2.5 years later, I joined a small pharmaceutical company as a regulatory medical writer. While the company ended up being a really bad fit, I learned a ton in my 9 months there, after which I decided it was time to go out on my own. Ritchie Scientific Consulting, LLC was born!
I took a teaching gig many years ago where I taught webinars and led in-person workshops around the US on writing clinical trial protocols, clinical study reports, and other documents/applications. I felt so energized when teaching and just knew in my heart that teaching is my mission!
I have SO many ideas as far as topics for training! I'm also considering different methods of providing training -- live multi-week workshops, mini-courses, cohort courses with an associated community, etc.
I am just launching my 12-week regulatory medical writing certificate program (so exciting!) and can't wait to see the impact!