If you've ever wished for a clear, practical path into the world of regulatory medical writing—this is it.
This 12-week intensive program is designed to fast-track your skills in regulatory writing with hands-on experience, expert guidance, and real-world assignments. Whether you're new to the field or looking to deepen your expertise, this program gives you the foundation, structure, and confidence to move forward.
Recorded lessons to watch on your own schedule.
Peer discussion prompts to deepen your understanding and connect with your cohort - don't worry, I'll be chiming in too!
Assignments using real data and documents, with direct, personalized feedback from me.
Weekly live office hours for Q&A, discussion, and support. These will be recorded in case you cannot attend live!
Access to me via email for additional questions that come up during the week.
Week 1: The Basics - The Drug Development Process, How Medical Writers Fit In, and Document Development
Week 2: Clinical Study Design and Writing the Protocol
Week 3: Assessing the Clinical Trial Protocol
Week 4: The Investigator's Brochure
Week 5: The Clinical Study Report
Week 6: Clinical Study Reports in Practice
Week 7: Clinical Trial Transparency and Data Disclosure
Week 8: Regulatory Submissions
Week 9: Product Labels and Patient-Facing Material
Week 10: Postmarketing Requirements
Week 11: Regulatory Strategy and Engaging with Health Authorities
Week 12: Wrap-Up
Hands-on, practical learning: You’ll be reviewing and writing real regulatory content—not just theory.
Community support: You’ll join a cohort of like-minded professionals to learn with and from each other.
Expert guidance: I’ll be giving personalized feedback on every assignment.
Certificate of Completion: Showcase your achievement to clients, employers, and networks.
"Caroline delivered an excellent regulatory medical writing training. The course syllabus was well-structured and thoughtfully designed, making it easy to follow and highly informative. She demonstrated exceptional professionalism and patience throughout the sessions, taking the time to address all types of questions with clarity and depth. Her breadth of knowledge in regulatory writing was evident and greatly enriched the learning experience. The platform she used for the training was effective and user-friendly, supporting smooth interaction and engagement. The discussion sessions were particularly valuable, allowing participants to explore topics in detail and clarify any uncertainties. Overall, this was a very well-conceived and executed training. With full commitment to the program, participants can gain a thorough understanding of regulatory medical writing. Caroline did a wonderful job facilitating a supportive and insightful learning environment."
"After completing several online regulatory medical writing courses, I still felt unprepared to produce core regulatory documents—clinical study protocols, clinical study reports, and other CTD components—with the level of precision the field demands. Finding Caroline’s 12-week regulatory medical writing program was a turning point. The course is comprehensive, practical, and far more valuable than its price tag. You gain hands-on experience, insight from Caroline’s decade of expertise, and a clear, structured approach to every document type. The weekly office hours are especially helpful—every question is welcomed, and nothing is left vague or unanswered. Most importantly, Caroline herself is patient, thorough, kind, and refreshingly straightforward. If you're serious about becoming a regulatory medical writer and ready to put in the work for three months, this program is absolutely worth it."
You've got questions. I've got answers.
The cost of this 12-week program is a 1-time payment of $1297. You will have access to all content for the lifetime of the Ritchie Scientific Consulting Academy.
Expect to spend 5 to 10 hours per week. Some weeks will be a bit lighter than others.
By signing up for this program, you are not only committing to yourself that you will maximize the benefit you receive from the program, but you are also committing to your peers. Due to the interactive nature of this program, your dedication and participation are expected.
Yes! Each weekly discussion prompt and assignment will have a due date. For you to get the most out of this program, I recommend completing each discussion requirement and assignment by the due date.
However, I do realize that you're probably juggling this program with a full-time job, working toward a degree, and/or raising children. You will have an additional week after the official end of the program to complete any outstanding assignments to obtain your certificate.
Once enrollment is closed, I'll reach out to all participants to find 2 time slots that will work during the week (I will aim to accommodate time zones of all participants). If you can't attend in person, office hours will be recorded and posted to rewatch. I will also be answering questions regularly throughout the week in our cohort community that you will be added to and via email.
You will have access to all course materials beyond the end of the program and for the life of this website.
You can receive a 50% refund if requested in writing before the end of Week 6. Please note that you will no longer have access to any of the course materials after you are refunded.
No problem! Shoot me an email at caroline@ritchiescientificconsulting.com.