Master scientific writing for clinical studies, reports, and FDA submissions.
Skills you will gain
- Effective Writing Techniques: Master clear, concise, and effective writing skills for healthcare industry documents.
- Document Development Process: Streamline the process from initial ideas to finished, polished documents.
- Regulatory Documentation: Understand the role of medical communication and regulatory documents in submissions.
- Scientific & Clinical Writing: Learn to write scientific reviews, study protocols, clinical reports, and more.
- Healthcare Industry Formats: Gain expertise in crafting press releases, investigator brochures, and scientific posters.
Course Description
All biopharmaceutical companies must produce scientific reports and summary documents for regulatory agencies. Good documentation should be not only scientifically sound, but also clear, effective and concise. This course provides the practical skills needed to write effective documents for the healthcare industry. You'll gain practice through hands-on exercises and group projects based on documentation used in pharmaceutical development.
Topics
- The essentials of good writing required for any profession, including the proper use of grammar and punctuation
- Copyright, permission, and ethics
- Working with journal editors and regulatory reviewers
- Writing letters to the editor, scientific review articles, clinical study protocols, clinical study reports, and press releases
- Preparing scientific posters
- Drafting documents that are user-friendly and comply with regulations
- Creating clear and concise content
Professional Credit
°®¶¹´«Ã½ EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 20 contact hours
- Online Traditional Complete online with instructor-set deadlines.
| Date | Start Time | End Time | Meeting Type | Location |
|---|---|---|---|---|
| Tue, 04-21-2026 | 12:01am | 12:02am | Online Traditional | ONLINE |
| Mon, 06-22-2026 | 11:58pm | 11:59pm | Online Traditional | ONLINE |
Online Traditional courses have a structured learning environment and fixed deadlines. This course is largely self-study with instructor guidance and includes online learning modules, assignments, and/or quizzes. All course materials and assignments will be available on Canvas, our learning management system.
For this section, student access begins on April 21, but you may still enroll until April 28. All course work must be completed by 11:59 pm on June 22, 2026.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
Recommended Texts:
Medical Writing, by Robert B. Taylor, Springer, 2011-08-18.
ISBN: 9781441982339
Medical Writing, by Robert B. Taylor, Springer, 2018-01-09.
ISBN: 9783319701257
This course applies to these programs: