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.