The Importance of Keeping Your Medical Writing Training FDA-Compliant

Medical writing involves the creation of scientific documents for a variety of purposes, which can range from submission to medical journals, promotional material on new drugs & medical devices, correspondence with the FDA & EMA to content for healthcare websites.

Medical writing is a highly technical field that the FDA believes is shifting from “a peripheral to a central role” with evolving responsibilities that cover a wide variety of aspects within the industry that may include strategy, marketing, project management, product development, and compliance.

Medical writing training is one of the easiest ways to ensure that your employees are writing material that’s both effective and compliant.

What Are the Benefits of Medical Writing Training?

Pharmaceutical, biotech, and medical device companies should invest in current medical writing training for their staff. With increased demand, finding quality medical writers isn’t easy.

Medical writing in the pharmaceutical field is an incredibly versatile tool. Businesses across the industry need it for various purposes, including:

• Reporting on the results of research projects
• Recording the development of new medical devices and drugs
• Providing documentation for governments and regulatory agencies
• Writing articles for medical journals
• Educating physicians and patients
• Marketing for new medicinal products

With the rise of the Internet, web content is playing a significant role in these cases as well.

Why Medical Writing Training Is Necessary

Medical writing is a lucrative field because the demand for professional reporting is significant in the industry. Most important, new knowledge enters the medical community every day, so informing many different audiences on novel findings can be a challenge. Complex research requires accurate and intelligible reporting.

Also, keeping your training up-to-date regarding medical documentation goes a long way to staying compliant with governmental bodies like the FDA. Businesses with excellent medical writers often experience fewer liability issues.

What Are the Challenges?

Don’t think a simple instruction manual is enough to produce acceptable medical writers. In fact, many companies struggle to find certified individuals for the task.

You need more than just a basic understanding of writing mechanics to succeed. Medical writers must have the following:

• An understanding of the medical industry, its concepts, terms, and regulations
• Academic qualification in medicine, biology, or any other relevant field
• Willingness to stick to guidelines, specifically the International Conference on Harmonisation (ICH) guidelines related to drug registration
• Involvement in the drug development process, including collaboration with industry professionals
• An ability to interpret data and statistics, which are common in the medical field
• A dedication to ethics, such as giving complete and accurate information without plagiarizing

Whether you’re looking to onboard new medical writers or enhance the skills of your existing ones, medical writing training can improve their skill set dramatically.

Get Your Training Done Right with CfPIE

Do you want medical writers with the right academic knowledge, research experience, attention to detail, collaboration skills, and a keen eye for compliance? 

Many businesses rely on medical training services like those offered by the Center for Professional Innovation and Education (CfPIE).

CfPIE is your ideal medical writing training and certification company. Here are just a few of the popular medical writing courses we offer:

• Technical Writing for Pharma, Biotech and Med Device
• Writing Effective Monitoring Reports and Good Documentation Practices: A Symbiotic Relationship
• Writing Effective SOP and Other Process Documents
• (CMWP) Certified Medical Writing Professional™

Please don’t hesitate to contact CfPIE at 1-610-648-7550 or [email protected] if you have any questions about our medical writing courses or certifications.