Fundamentals of Medical Writing

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.

This is a comprehensive hands-on course for the clinical and regulatory focused individual in the pharmaceutical industry that will allow you to apply your skills to almost any regulatory document. This 10-week course provides students with an overview and best practices for writing clinical study protocols and clinical study reports, two of the most common document types in contemporary medical writing. Topics also include a detailed background on the drug approval process and additional insights into the tools of the trade. Templates, ICH guideline content requirements and standard industry guidelines will be covered. This is an excellent program for the 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.

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 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 10 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.

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 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.

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