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Author Archives: Jacquie Powell

Professional Organizations for Emerging Medical Writers

February 8, 2017 | Jacquie Powell, PhD | Medical Writing Services

Attending professional networking events can seem intimidating, especially for graduate students and postdocs with limited professional experience outside of academia. This post provides a list of great professional organizations that some of the folks here at IMPACT have found to be particularly helpful, both nationally and in our local Research Triangle Park (RTP) area.

We hope you find this list helpful, and let us know if we missed anything!

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5 Professional Networking Tips for Emerging Medical Writers

January 16, 2017 | Jacquie Powell, PhD, and Ashley Godfrey, PhD, RAC, Clinical Research Scientists | Medical Writing Services

We have talked to a number of transitioning scientists who have a hard time understanding why they should engage in professional networking. One postdoctoral fellow summed it up by saying, “I know I should network but it just feels so dirty.” This made us laugh and helped us remember our own disconnect as we were going through the process of leaving academic science to enter the field of medical writing.

In an effort to help others bridge the gap, this blog post provides 5 professional networking tips we have learned along the way.

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What About Medical Writing for Non-Regulatory Writers?

September 29, 2016 | Jacquie Powell, PhD, Clinical Research Scientist II | Medical Writing Services

As a whole, medical writers (including those outside of the regulatory field) are a diverse group of professionals with a wide variety of different job descriptions, job titles, and responsibilities.

The unifying theme among medical writers is that they spend most of their time creating medical or health-related documents. But, given the enormous breadth of the medical field, medical writers often find themselves doing very different jobs depending on how they fit into the grand scheme of things.

While IMPACT predominantly focuses on regulatory writing, the purpose of this post is to highlight other potential medical writing career paths. It’s by no means a fully comprehensive list of medical writing opportunities, but we hope it provides some background and a couple of targeted terms that may be useful in your job search.

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Who Hires Regulatory Medical Writers?

September 14, 2016 | Jacquie Powell, PhD, Clinical Research Scientist II | Medical Writing Services

Towards the end of my postdoc, as I started to reach out to local regulatory medical writers, it seemed that everyone in the field had a convoluted story about how they ended up in the field. While it was interesting to hear their stories, it was discouraging too, because it was tough to know how to position myself.

Here are a few things I learned along the way about how to break into regulatory medical writing and who hires regulatory medical writers.

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What is the FDA’s Biomarker Qualification Process?

May 26, 2016 | Jacquie Powell, PhD, Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Similar to Clinical Outcomes Assessments (COAs), biomarkers also have a qualification program that was developed by the Center for Drug Evaluation and Research (CDER) as one of the Drug Development Tools (DDT) Qualification Programs.

scopeJust like our previous post on the COA Qualification Program, this post discusses the Biomarker Qualification Program from a drug-development point of view.

What is a biomarker?

A biomarker is a measurable indicator used to assess: (1) a normal biologic process, (2) a pathogenic process, or (3) a response to an intervention or exposure.

One important thing to keep in mind is that, unlike COAs, biomarkers do not assess how individuals feel, function, or survive in their daily lives. As such, biomarkers are less subjective than COAs.

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