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Category Archives: Medical Writing

Why and How to Conduct a Strategic Review of Regulatory Documents

November 16, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing and Corporate Communications | Medical Writing Services

As regulatory medical writers, we are trained on how to write for regulatory audiences, but how often are a Sponsor’s project teams trained to review the regulatory documents we write? At IMPACT, our answer is – as often as possible.

We encourage our project teams, as well as our internal staff, to use strategic review practices whenever possible, to ensure an effective, efficient review. We have trained internal and external reviewers accordingly, both with excellent results.

In this post, we’ll share the keys for an effective strategic review of regulatory documents. Please consider following these tips during your next review and let us know how it goes!

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CORE Reference for ICH E3 Clinical Study Report Authoring: Evolving with the Times

July 13, 2017 | Ilana Dew, PhD, Senior Clinical Research Scientist | Medical Writing Services

You may be a seasoned regulatory medical writer who has authored dozens of Clinical Study Reports (CSRs) and can recite the contents of the 1995 International Council for Harmonisation (ICH) E3 Guideline on the structure and content of CSRs with your eyes closed.

Or, you may be new to the profession. You’ve seen our blog series on getting started in the field, you have accepted a position in regulatory medical writing, and came here looking for some direction on how to interpret the ICH E3 recommendations and put together your first CSR.

Whether you fall into the former description, the latter, or anywhere in between, there’s something new that you are going to want to see.

It’s the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual, created to guide authors toward best practices for creating CSRs with new clinical trial transparency and disclosure regulations in mind.

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Most Common Advice We Give First Time NDA/BLA Submission Teams

June 14, 2017 | Jennifer Moen, PhD, RAC, Associate Director Medical Writing & Corporate Communications | Medical Writing Services

Throughout the years, our staff at IMPACT has worked with many clients on marketing applications (large and small) across a variety of therapeutic areas. Each one comes with its own unique challenges, but the most interesting (and often the most exciting) are those where the client is working on a submission for the first time.

Such client teams can represent a small company bringing their first drug to market, or a first-time team within large pharma. Though their corporate atmospheres may differ, the challenges they face on their first submission can be similar.

Without further ado, here are the most common 5 pieces of advice we give to first time submission teams. [Reader’s Note: In this post I use the term “submission” to mean a marketing application (eg, NDA, BLA, MAA).]

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University Resources for Aspiring Scientific and Medical Writers in the Research Triangle Park Area

February 22, 2017 | Kathryn Tworkoski, PhD, Clinical Research Scientist II | Medical Writing Services

Finding a job is hard—finding a job in a new field can be even harder. As someone who recently broke into the field of medical writing I’m familiar with the associated challenges, but I can also tell you that the reward is more than worth the work!

Image courtesy of Renjith Krishnan at FreeDigitalPhotos.net

IMPACT recently created a series of blog posts to help others make similar career transitions by highlighting local resources available to aspiring scientific and medical writers.

Previous posts discussed professional networking tips, how to use social media to make your transition, and professional organizations for emerging medical writers.

In this post, I’ve compiled a list of useful programs and opportunities provided by local universities in the Triangle area of North Carolina. Italic text denotes opportunities that are available to everyone, even people not affiliated with a university.

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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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