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What Does a Regulatory Medical Writer Do All Day?

August 11, 2016 | Nancy Smith, PhD, Senior Manager, Medical Writing and Submissions Management | Medical Writing Services

In my last post, I explored my transition from the bench to regulatory medical writing. I knew little about medical writing when I started, but quickly learned that it’s is an exciting mix of summarizing data, educating your clients/teams on regulatory considerations, and becoming a bit of a social dynamic expert.

In thinking about the best way to tell you what regulatory medical writers do each day, I thought that walking you through the potential career progression of a medical writer may be the best way.

That way you can see that it’s way more than just writing…and if you like what you read, then maybe this is a career option for you!

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[Keep in mind that the descriptions below are from the CRO (IMPACT) perspective.]

Entry-level (eg, Clinical Research Scientist I/II): Medical Writing

As an entry-level regulatory medical writer, the most time is spent analyzing and summarizing data from clinical trials for a variety of audiences, but predominantly regulatory authorities (eg, the FDA).

Entry-level writers often start out writing Clinical Study Reports (CSRs) that summarize the design, conduct, and results of a clinical trial. (For those of you interested in seeing the structure of a CSR, click here.)

Typical activities of an entry-level writer may include:

  • summarizing safety and/or efficacy data for a CSR,
  • incorporating comments from your Project Manager or Project Team,
  • proposing a project timeline at a team meeting,
  • participating in a roundtable meeting (sometimes called comment resolution meeting),
  • getting exposure to other regulatory documents (via training or working with a more senior writer), or
  • performing a quality control (QC) check of a fellow writer’s CSR.

What is QC, you ask? Quality control of a document involves a 100% data check, as well as checking grammar, consistency of language, and adherence to a style guide (guidelines to define the style of writing for a particular compound, ensuring consistency across documents). Some companies have their own QC department, where in other companies (like IMPACT), QC is performed by our medical writing peers. Attention to detail is crucial here.

Mid-Level (eg, Sr. Clinical Research Scientist): Project Management

As a writer’s career develops, the focus shifts to project management as well as writing more complex regulatory documents (eg, components of a New Drug Application [NDA] – click here to see the structure of an NDA).

Typical activities of a mid-level writer may include:

  • reviewing documents written by entry-level writers and providing constructive feedback,
  • attending conference calls to discuss messaging across documents within an NDA,
  • participating in a team meeting to shorten timelines for a critical document,
  • discussing budget, timeline, or resource needs with a client, or
  • leading a roundtable meeting to discuss a client’s review of a document.

Client meetings require a mix of diplomacy and regulatory experience to achieve one goal: provide the highest quality document to the client in (usually) the shortest time possible.

The ability to be efficient, organized, and flexible are translatable skills from many different backgrounds that will serve you well as a regulatory medical writer.

Principal and Manager Level: Management and Mentorship
In addition to writing and project management, as your career progresses, other opportunities become available. Depending on your interests, this could include line management and/or managing complex projects or programs.

Line managers oversee resourcing of projects as well as provide mentoring/career development guidance to ensure writers gain exposure to new and different types of projects.

At this level, medical writers may act as project managers over an entire NDA (or the European equivalent, an MAA [Marketing Authorisation Application]) or manage other large or complex regulatory writing projects.

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Where your career goes from here depends on you and your individual abilities and preferences. Cool stuff, huh?

Are you considering a transition into regulatory medical writing? We highly recommend an informational interview to help you determine if the career path is the right one for you. Also, stay tuned for our next post on the skills needed to make a good regulatory medical writer.

If you have any questions, please don’t hesitate to reach out.

Images courtesy of cuteimage and pakorn, respectively, at FreeDigitalPhotos.net.

Category: Medical Writing Services,
Keywords: medical writing, regulatory medical writing, medical writer, regulatory medical writer

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