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.

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 10-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.

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Medical Writing of NDA Clinical Modules

Writing the clinical documents of an 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.

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Clinical programming

CLINICAL PROGRAMMING

These introductory courses walk the aspiring programmer through high-level concepts related to clinical programming in the life science industry.

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Trial disclosures

TRIAL DISCLOSURES

In these unique courses, students will learn about the legal and ethical basis for trail disclosure and clinical trial protocols and results.

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Medical Writing

PHARMACOVIGILANCE

These courses offer entry level medical professionals the fundamentals of medical coding and its application in clinical trial data sets.

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