Medical writer vs regulatory affairs specialist

The differences between medical writers and regulatory affairs specialists can be seen in a few details. Each job has different responsibilities and duties. While it typically takes 1-2 years to become a medical writer, becoming a regulatory affairs specialist takes usually requires 2-4 years. Additionally, a medical writer has an average salary of $93,842, which is higher than the $70,060 average annual salary of a regulatory affairs specialist.

The top three skills for a medical writer include medical writing, patients and clinical research. The most important skills for a regulatory affairs specialist are regulatory affairs, FDA, and regulatory agencies.

Medical writer vs regulatory affairs specialist overview

	Medical Writer	Regulatory Affairs Specialist
Yearly salary	$93,842	$70,060
Hourly rate	$45.12	$33.68
Growth rate	6%	-
Number of jobs	59,516	9,915
Job satisfaction	-	-
Most common degree	Bachelor's Degree, 57%	Bachelor's Degree, 66%
Average age	46	46
Years of experience	2	4

What does a medical writer do?

As the name entails, medical writers produce technical, educational, promotional, and technical content. They typically work with physicians, scientists, and subject matter experts to produce documentation that defines product usage and research results. Their duties and responsibilities may vary, but they perform some common tasks, including developing documentation related to clinical trials, creating monographs, and developing promotional materials. Medical writers are also responsible for creating grant proposals, writing newspaper and magazine articles, and creating presentations for conferences.

What does a regulatory affairs specialist do?

A regulatory affairs specialist assists in securing and maintaining government approval for nutritional products, drugs, medical devices, and related supplies. They are often employed by medical, pharmaceutical, and biotechnology companies. They may also work in the government or law. Typically, they work on document preparation, file maintenance, information management, and coordination of tasks across various departments. They expanded their duties and responsibilities as a result of company acquisitions and restructuring, worldwide globalization of markets, and constantly evolving regulations.

Medical writer vs regulatory affairs specialist salary

Medical writers and regulatory affairs specialists have different pay scales, as shown below.

	Medical Writer	Regulatory Affairs Specialist
Average salary	$93,842	$70,060
Salary range	Between $63,000 And $137,000	Between $49,000 And $99,000
Highest paying City	Washington, DC	Santa Rosa, CA
Highest paying state	Virginia	California
Best paying company	Biogen	Meta
Best paying industry	-	-

Differences between medical writer and regulatory affairs specialist education

There are a few differences between a medical writer and a regulatory affairs specialist in terms of educational background:

	Medical Writer	Regulatory Affairs Specialist
Most common degree	Bachelor's Degree, 57%	Bachelor's Degree, 66%
Most common major	Biology	Business
Most common college	University of Southern California	Stanford University

Medical writer vs regulatory affairs specialist demographics

Here are the differences between medical writers' and regulatory affairs specialists' demographics:

	Medical Writer	Regulatory Affairs Specialist
Average age	46	46
Gender ratio	Male, 33.6% Female, 66.4%	Male, 37.5% Female, 62.5%
Race ratio	Black or African American, 6.6% Unknown, 5.0% Hispanic or Latino, 7.8% Asian, 8.7% White, 71.5% American Indian and Alaska Native, 0.4%	Black or African American, 10.7% Unknown, 4.5% Hispanic or Latino, 15.7% Asian, 8.2% White, 60.1% American Indian and Alaska Native, 0.8%
LGBT Percentage	11%	12%

Differences between medical writer and regulatory affairs specialist duties and responsibilities

Medical writer example responsibilities.

Develop network of science contacts at NASA to inform stories and generate new leads.
Manage, and assist in the recruiting activities of, CRO resources preparing regulatory documents on behalf of APGD.
Create and maintain account profiles for contributors, including writing of biographies, gathering headshots, and creating and managing accounts.
Create manuscripts, abstracts, and PowerPoint slide decks for a prominent pharmaceutical client.
Prepare CSRs, IB updates, protocols, protocol amendments, and statistical analysis plans.
Draft scientific content for abstracts, posters, manuscripts, and slide presentations (CNS )

Regulatory affairs specialist example responsibilities.

Gather, evaluating, organizing, managing and collating information in a variety of formats.
Manage CRO (regulatory) in support of the company's approve product in Europe.
Manage and submit electronic EPA product registrations.
Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
Support complaint handling process and screening, ensure FDA 21 CFR compliance.
Close complaints receive from external customers in compliance with FDA, ISO, QSR and other regulatory guidelines.

Medical writer vs regulatory affairs specialist skills

Common medical writer skills

Medical Writing, 11%
Patients, 8%
Clinical Research, 6%
Clinical Study Reports, 6%
Literature Searches, 5%
FDA, 5%

Common regulatory affairs specialist skills

Regulatory Affairs, 10%
FDA, 8%
Regulatory Agencies, 7%
Medical Devices, 6%
Regulatory Compliance, 5%
Regulatory Submissions, 5%

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Medical Writer vs Regulatory Affairs Specialist

Updated January 8, 2025

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