The Fundamentals of Medical Writing

Being a successful medical writer requires an understanding of the drug development process, a strong grasp of scientific principles, and the ability to write clearly and effectively.

Our hands-on course for the clinical and regulatory focused individuals in the pharmaceutical industry will allow you to apply your skills to almost any regulatory document. This 12 week course will focus on learning how to interpret data and write standard regulatory documents. Also covered is a detailed background on the drug approval process and associated documentation. Templates, ICH guideline content requirements and standard industry guidelines will be covered as well as hands-on exercises for various essential clinical documents, protocols and clinical study reports. 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 the student or scientist interested in a career as a medical or regulatory writer in the pharmaceutical industry and a continued learning opportunity for the writer already working in the field.

This course provides practical preparation for for medical writing and will offer a background on medical writing requirements, and two medical writing exercises that will cover a clinical study protocol and a clinical study report.

At the end of this course, students will have a foundation in drug development background, and be able to write a clinical study protocol and clinical study report.

 

Duration and Prerequisites

A total of 12 weeks is needed for completing the program.

Education and/or Experience
A BS in life sciences field, graduate level education is preferred.* Experience in pharma is a plus.

Minimum Expectations
An understanding of scientific writing (e.g. through manuscripts, posters/abstracts, grant writing).

Must have a strong understanding of Microsoft Office®.

Strong desire to understand fundamentals of regulatory writing and the regulatory environment.

Assessments
Knowledge checks will be performed through a quiz in every session. Evaluation of written reports will be performed through multiple assignments/exercises and will conclude with a final examination. A minimum of 75% is required to pass the final examination.

 

 

* Degrees or diplomas from educational institutions outside the United States must be equivalent to degrees from U.S. educational institutions.

Scholarships & Internships

Find out if you qualify for scholarship support or an internship opportunity with with MMS.

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