Medical Writing of NDA Clinical Modules
Medical Writing of NDA Clinical Modules
Writing the clinical documents of a standard new drug application (NDA), requires an understanding of the drug development process, a strong grasp of scientific principles, and the ability to write clearly and effectively. It also requires a grasp of the type of data included in each module as well as the key purpose each section serves.
Our hands-on course for clinical and regulatory-focused individuals in the pharmaceutical industry will allow you to apply your skills to the clinical documents in an NDA submission. This 8-week course will focus on learning how to interpret and organize clinical data and write standard clinical documents in an NDA submission. Also covered is an overview of the NDA’s role in the drug approval process and the guidelines and regulations that dictate the content of an NDA. Lead medical writer responsibilities will be covered as well as hands-on exercises for a key essential clinical NDA submission document. Additional insights into the tools of the trade are also integrated into the course material.
Who Should Take This Course
This is an excellent program for:
- A student or scientist interested in a career as a medical or regulatory writer in the pharmaceutical industry who has already completed the MMS Academy Course in the Fundamentals of Medical Writing.
- A writer already working in the field that is interested in continued learning opportunities.
At the end of this course, students will have a foundation in the requirements for writing clinical documents in a standard NDA submission. Additionally, the student will gain hands-on experience with some of the complex aspects of presenting clinical data.
Duration and Prerequisites
A total of 8 weeks is needed for completing the program.
Education and/or Experience
A BS in the life sciences field, graduate level education is preferred.* Experience in pharma is a plus.
Experience in writing regulatory documents for drug development (CSRs and Protocols experience required) OR completion of The Fundamentals of Medical Writing.
System Requirements
Must have a strong understanding of Microsoft Office®.
Assessments
Knowledge checks will be assessed through a quiz in every session. Evaluation of written reports will be assessed through multiple assignments/exercises and will conclude with a final examination. A minimum of 75% is required to pass the final examination.
Accreditation and Certification
This course is accredited by the Accreditation Council for Pharmacy Education (ACPE).
* Degrees or diplomas from educational institutions outside the United States must be equivalent to degrees from U.S. educational institutions.
MEET THE INSTRUCTORS
MMS Academy features a number of top life science experts in presenting and training students and working professionals through our coursework.
Get Certified
Understanding the difference in various types of certification is important before pursuing any online education program. MMS Academy provides assessment-based certificates in compliance with ICE 1100 standards.
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“I was a laboratory-based biotechnologist who was looking for a career that would allow me to work from home to accommodate my family needs. Although I had a strong scientific background, I had no previous experience as a medical writer and the MMS Academy course provided me with the skills to understand and compile the document types that are always needed in clinical trials. This helped immensely and I did not feel as overwhelmed at all when starting my first job as a medical writer.” –
Former student
“MMS Academy prepared me for my career in medical writing by offering real life examples of what goes into writing clinical documents. The content of the modules was informative and well-structured to facilitate an understanding of what medical writing is and what will be expected of you when you become a medical writer.”
Former student