Regulatory Medical Writer: Job Description, Duties and Requirements

Apr 06, 2021

Regulatory medical writers work with other technical and medical professionals to develop documents for government review. They typically have at least a bachelor's degree and a strong understanding of medical terminology.

Essential Information

Writers who have an interest in medicine might find work as a regulatory medical writer appealing. A regulatory medical writer is a type of technical communicator who specializes in preparing documents for review by government agencies. In addition to writing skill, medical writers must possess highly specialized knowledge of medical laws and regulatory processes. People in this profession usually have a bachelor's degree. Certification is also available.

Required Education Bachelor's degree
Other Requirements Medical background
Projected Job Growth (2019-2029)* 7% (technical writers)
Median Salary (2020)* $74,650 (technical writers)

Source: *U.S. Bureau of Labor Statistics

Job Description

A regulatory medical writer has to take technical specifications from medical workers and arrange that information as part of a compliance package. Many regulatory writers work for biomedical and pharmaceutical firms, which means that many of their regulatory guidelines come from the Food and Drug Administration (FDA). Many of these specialized technical writers actually begin their careers as practitioners of their field of writing expertise, according to the U.S. Bureau of Labor Statistics.

Job Duties

Like many other technical writers, medical regulatory writers must coordinate with various technical professionals to gather, organize and compile information on new products or processes. Many regulatory medical writers work for either biomedical or pharmaceutical development companies, compiling the paperwork necessary to submit new drugs and therapies for review by the FDA and other organizations.

These regulations can vary significantly. FDA guidelines state, according to section 312.23 of the Code of Federal Regulations, that Investigational New Drugs (IND) require the submission of a document that includes sections on the protocol for each planned study, chemistry and manufacturing information, toxicology information, previous human experience with the drug and any additional information. In addition to these initial submissions, the FDA might request carefully formatted safety reports throughout the IND process. These are only some examples of the duties that a regulatory writer must fulfill.

Education Requirements

Medical regulatory writers generally need a bachelor's degree in English, communications or journalism. A background in the medical field is also generally expected. In many instances, a regulatory medical writer is previously employed in a medical field before gaining credentials as a writer. Though not required, a medical writer also might seek certification from the American Medical Writers Association.

Employment Outlook and Salary Information

According to the U.S. Bureau of Labor Statistics (BLS), in May 2020, technical writers, including regulatory medical writers, earned an annual median salary of $74,650. The BLS predicted 7% employment growth for technical writers from 2019-2029, which is faster than the average.

Those who are interested in both writing and medicine might find a future in the field of regulatory medical writing. A bachelor's degree in an English-related field combined with a medical background is ideal for regulatory medical writers. The American Medical Writers Association also offers optional certification in this field.

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