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.
Content is released over 12 weeks, but you can complete in 12 weeks, 16 weeks, or however long you need - plus lifetime access!
Recorded lessons to watch on your own schedule.
Focused and organized content, with a new topic each week that builds on the previous material.
An online community , with space to ask questions and learn from other regulatory medical writers.
Peer discussion prompts to deepen your understanding and think critically about each week's topic. Your instructor (Caroline) will be chiming in too!
Assignments using real data and documents, with direct, personalized feedback from Caroline (some of these assignments would make a great piece of work for your portfolio).
Live office hours for Q&A, discussion, and support.
Access to Caroline via email for additional questions that come up as you go through the material.
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 community 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 your network.
"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 $997 or 3 monthly payments of $397. 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 if you plan to get through the entire program in 12 weeks. Some weeks will be a bit lighter than others.
Since this program is self-paced, you can spend as much time as needed to get through the content. If you only have 1 or 2 hours each week, that is fine! You can even take a week or two off if life gets busy! Take as much time as you need!
I highly recommend completing each week's material before moving on to the next week.
Upon registering for the program, you will be added to my "Regulatory Medical Writing Community" that is only accessible to program participants.
This community is set up like a forum, with pinned posts containing important program information. This includes a calendar and Zoom link to upcoming office hours and a space for each week's discussion topic. You can create posts with questions or your own topics for discussion that other program participants and I (Caroline) can respond to.
Yes! Completion of each week's assignment AND discussion prompt is required to earn a certificate of completion.
I want to ensure that obtaining this certificate actually means something within the industry!
There will be multiple time blocks set aside each week. If none of the times work for you, I can set up an additional time block. The timing will aim to accommodate all time zones. If you have urgent questions and none of the upcoming office hour sessions work for you, I am willing to set up an ad hoc session that works with your availability.
You will have access to all course materials and the community for the lifetime of the Ritchie Scientific Consulting Academy.
You can receive a 50% refund if requested in writing before Week 7 content is released. Please note that you will no longer have access to any of the course materials or the community after you are refunded.
No problem! Shoot me an email at caroline@ritchiescientificconsulting.com.