Regulatory writers are the best-paid professionals in the
Medical Writing Industry. In fact, many of them 
earn six-figures. Look at these data from the American Medical Writers Association 2007 Salary Survey:
Mean Income by primary Employer
Biotechnology company: $102,297
Pharmaceutical: $97,807
Medical device company: $85,451
With new drug, devices, and treatments being developed every day, pharmaceutical, biotech, medical devices companies, and Contract Research Organizations (CROs) are hiring knowledgeable writers who understand the regulatory process in the United States. You can even be a freelance regulatory writer if you wish (according to the AMWA survey, the mean gross income for the freelancers interviewed was $119,295).
As a regulatory writer you should have good knowledge of clinical study design and conduct; how to write protocols and how to read and interpret clinical data (summary tables and listings). You should also be aware of case report form design, good clinical practice (GCP) regulations and regulatory document guidelines such as the ICH.
With this online course you can learn the basics of regulatory writing without spending a fortune or leaving your house or office. The course was developed by a regulatory writer with almost 30 years of experience in the industry.
“This online training provided me with convenient and fundamental knowledge of the FDA’s regulations for drugs and devices. I would recommend this course to anyone who needs background knowledge or is just starting out learning the regulations.”
Dawn Pearson
Seattle, WA
Complete this online course and receive a Certificate.
Are you a clinical research professional who is charged with writing a clinical study protocol?
Or a medical writer looking for guidelines to use for writing an IND for a new drug? If so, this course is for you.
In today’s competitive job market, educational credentials are vital. Add a line to your resume and show potential employers and editors that you have what it takes to be an excellent regulatory writer!
This course is divided in two modules. While the first module (Introduction to Regulatory Writing) teaches the drug development and approval process in the United States, the second module (Clinical Trial Reporting) describes how to prepare regulatory documents.
“I’ve worked as a nurse (15 years), clinical research coordinator (5 years), consultant, writing SOPs for Pharma companies (2 years), then medical writing (7 years and counting). The latter is the best job I’ve ever had, as it draws on so many different parts of me. I was in the right place at the right time at so many points in my life. I could chalk it up to luck, but I also remind myself of Pasteur’s observation: “Chance favors the prepared mind.” If you are considering a career in medical writing, don’t be afraid to take a risk. Try it, you might like it!”
Becky Hansen
Regulatory writer, MGI PHARMA
Bloomington, Minnesota
Module I: Introduction to Regulatory Writing
- How Medical Products are Classified: Distinction between Pharmaceutical Drugs, Biologics, Medical Devices, or Combination Products
- FDA’s Regulatory Divisions
- Details Regarding Regulatory Planning, Documents Preparation, and FDA Submissions to Gain Market Approval of Drugs in the USA.
A. The Drug Regulatory Process
B. Details Regarding Preclinical Research
C. Details Regarding INDs
D. Conducting Human Clinical Trials
E. The FDAs Regulation on Good Clinical Practice (GCP)
F. Submitting a New Drug Application (NDA)
G. Pre-launch Activities
H. Launch Activities
I. The Product Sales Cycle
- FDA Regulation to Gain Market Approval of Biologics in the USA.
A. What are Biologics?
B. Biologics Clinical Trials Manufacturing
C. Differences and Similarities between Biologics Development and New Drug Product Development Regulations
D. Submitting a Biologics License Application for FDA Market Approval of a Biologic
- FDA Regulation to Gain Market Approval of Medical Devices in the USA.
A. The Medical Device Classification
B. Premarket Notifications or 510(k)
C. Premarket Approval Applications (PMAs)
D. PMA Supplementation
E. Humanitarian Device Exemptions (HDEs)
F. Investigational Device Exemptions (IDEs)
G. IDE Amendments
H. Product Development Protocols (PDPs)
I. Medical Device Code of Federal Regulations (CFRs)
J. Steps to Obtaining Marketing Clearance from CDRH
K. Other Requirements besides Marketing Clearance
Module II: Clinical Trial Reporting
Clinical trials have very stringent guidelines that must be followed. The same is true regarding the documentation required by the Food and Drug Administration. If these guidelines are not followed, then the entire regulatory approval may be delayed or jeopardized altogether.
Medical writers and clinical research professionals must understand the regulatory requirements for all regulatory reports that they are required to write during their careers.
This module distills the regulations regarding the most common regulatory documents into a single, user-friendly guide. This module will show you how to develop each of these documents:
- Pre Investigational New Drug (IND) Application
- Investigational New Drug (IND) Application
- Investigational New Drug (IND) Reports
- Informed Consent Form
- Investigator’s Brochure
- Clinical Reports
- Pre New Drug Application (Pre-NDA)
- New Drug Application (NDA)
- Patient Narratives
- Manuscripts
At the end of the course you will take a test to evaluate your understanding of the material and receive a certificate of completion.
More affordable, comprehensive, and time efficient than available workshops.
Many of the available workshops for regulatory writers are way too expensive—$1,950 or more for a couple of days, plus travel expenses.
You can take this online course from the comfort of your home. Once your interactive test is completed and your instructor gets back to you, you will receive a Certificate in the mail at no extra cost.
Complementary Gift for Signing Up Today
A complementary copy of the ebook Becoming a Medical Writer: How to launch a successful career writing about medicine and health. A $29 value.
Yes, Sign Me Up for this Online Course – $297
Pay by credit card or your Paypal account.
Service Guarantee
A confirmation email with instructions on how to access the online Course will arrive to your inbox within 24 hours.
Because we give you complete access to Course materials, all sales are final upon purchase. No refunds are available.
We are committed to your success in medical writing training, as we know you are. We are available to you by email and phone appointment when you have questions.
Tax Deductible – Keep your receipt. In the USA, all expenses of continuing education undertaken to maintain and improve business and professional skills are tax deductible. (Treas. Reg. 1-162-5). Please contact your tax consultant for further information.
