Becoming a Regulatory Medical Writer: Salary & Job Description

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What are the pros and cons of becoming a regulatory medical writer? Get real job descriptions, career prospects and salary information to see if entering this profession could be the right choice for you.
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Pros and Cons of Becoming a Regulatory Medical Writer

Regulatory medical writers are technical writers who write or edit regulatory documents for government agencies, medical schools and pharmaceutical companies. Read on to learn more about the pros and cons of becoming a regulatory medical writer.

Pros of a Regulatory Medical Writing Career
Generally high level of job satisfaction*
Job opportunities should be good (15% employment growth from 2012-2022)**
Might be able to freelance from a home office*
Various types of education available: certificates, degrees and standalone courses*

Cons of a Regulatory Medical Writing Career
Competition exists among freelance writers**
Might have to work nights and weekends because of time zones or deadlines**
Possible high stress situations***
Jobs are often quite sedentary, with most time spent at desk or computer**

Sources: *American Medical Writers Association (AMWA), **U.S. Bureau of Labor Statistics, ***O* Net OnLine.

Career Information

Job Duties

As a regulatory medical writer, your writing might include investigatory new drug documents, new drug application submissions or summaries of efficacy and safety. You might collaborate with a team to produce documents, such as the results of clinical trials or an interpretation of correlation and regression analyses. You could work for a specific firm, such as a clinical research organization or a pharmaceutical company. Some medical writers work on a freelance basis and get paid separately for each assignment.

Salary Info and Job Prospects

In May 2014, the BLS reported an average salary of about $72,000 for technical writers. According to Salary.com, entry-level medical writers earned a median salary of about $59,000 as of Sept. 2015. The number of employed technical writers is expected to grow 15% from 2012-2022, which is faster than average.

What Are the Requirements?

Education and Training

To secure employment as a medical writer, you often need at least a bachelor's degree or experience in English, journalism and communications, in addition to education or experience in a field connected to medicine. A few graduate programs in medical or science writing are available, and many schools offer continuing education courses in medical writing. Some professional organizations, such as the American Medical Writers Association (AMWA) and the Drug Information Association (DIA), offer courses in medical writing as well.

Skills and Attributes

The ability to grasp complex medical and health sciences information is critical for aspiring medical writers. The AMWA notes that professional writers should also know how to perform literature searches and simplify complicated concepts. Research skills are essential; you need to be able to gather, analyze and interpret data. Strong time-management and computer skills are important as well.

What Are Employers Seeking?

Most employers require a bachelor's degree and several years of related work experience. Read the following excerpts from real job postings to learn what employers were looking for in April 2012:

  • A pharmaceutical company in North Carolina advertised for a senior-level medical writer to focus on clinical documents and clinical portions of regulatory submissions. This employer required a related 4-year degree, six or more years of similar experience and extensive knowledge of clinical document formats and techniques.
  • A medical device company in New Jersey was looking for a clinical and regulatory medical writer to fill a 1-year position. Primary duties involved providing comprehensive documentation for U.S. Food and Drug Administration regulatory submissions. This company required a bachelor's degree, 1-3 years of similar work experience and knowledge of various computer-publishing programs.
  • A biotechnology company in Maryland advertised for a medical writer to work on the production and revision of clinical research protocols and consent documents. You'd research, write, edit and assist with new program implementation. This employer required a bachelor's degree in biological/biomedical science or four years of related experience. In addition, five years of experience in a pharmaceutical or clinical environment, including technical writing and editing, were required.

How to Make Your Skills Stand Out in the Field

If you have a bachelor's degree in a science or healthcare field, taking courses in medical or science writing could help you stand out from the crowd. Many college and university continuing-education departments offer these courses in standalone formats or as part of related certificate programs. According to the BLS, Web design skills may help you land a job as well, so think about taking courses in that field.

You may also consider joining a professional organization, like the AMWA. Members of these organizations often have access to networking opportunities, job boards, training workshops and annual conferences.

Other Careers to Consider

Editor

If the editing aspects of a writing career are especially appealing to you, maybe you should consider becoming an editor. Editors usually have college degrees and work in offices or from their homes. They're primarily responsible for planning, reviewing and revising content before publication. According to the BLS, employment of editors wasn't expected to change much, growing by about one percent from 2010-2020. The average salary for editors was about $60,000 as of May 2011.

Public Relations Manager and Specialist

If you'd like to consider a career with faster projected job growth than that of a technical writer, think about working in public relations. An individual working in this occupation creates and maintains a positive public image for clients. You'd write media releases, plan public relations programs and help raise funds. To enter this profession, you usually need a bachelor's degree, and previous experience is a plus.

The number of employed public relations specialists and managers was expected to grow 21% from 2010-2020, which is faster than the average for all occupations. According to the BLS, the average salary for public relations managers was $106,000 as of May 2011. During that time, public relations specialists earned an average of $60,000 per year.

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Johns Hopkins University

  • Master of Science in Regulatory Science

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Kaplan University

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American National University

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Regent University

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Penn Foster

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Penn Foster High School

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