Medical Writing & Pharma
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released a third revision of its E6 Guideline, also known as ICH E6 (R3). This revision introduces new concepts and updates in the realm of clinical trial methodologies, with an emphasis on quality, flexibility, and modernization. Let’s explore the key updates and discuss how they might affect medical writers.
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By Katelyn Rivas Last year I had the pleasure of participating in the Synterex Regulatory Writing and Medical Communications Fellowship. I worked with and learned from Synterex staff members across all areas of the business, including medical writing, project management, quality control (QC), publishing, and business operations. Now that I have completed my fellowship and…
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We asked ChatGPT to tell us a story about a medical writer; here’s what it got right and what it got wrong. Like many of you, when ChatGPT appeared in the news recently (mainly in reference to stories about students misusing the technology), I was curious. There have been many times in recent years when…
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Business skills matter. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version. Background Managers need the ability to orchestrate a company’s resources in a way that balances value proposition against cost and other multidisciplinary dynamic factors. Because medical writers tend to learn…
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Difficult people exist in any profession. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version. Sooner or later, you’ll have to work with someone whose personality clashes with yours. They may be a coworker, a client, a vendor, a boss, or a…
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Checklists are a great tool. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version. We have a complicated job. Every day there are new tasks to manage, learn, and get right. No matter how much experience and training you have, relying on…
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If you work for a team that tackles complex tasks, you are likely familiar with the benefits of having a project manager. Project managers ensure that the team achieves its goals within the given budget and time constraints. But do you know what a regulatory project manager is, and how their specialized expertise can help…
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Each year, Synterex is proud to welcome students and postgrads to a medical writing internship or fellowship. Our current intern, Alex, and our current fellow, Katelyn, answer some questions about the experience so far. What is your educational background? Alex: I am a rising senior at Clark University, currently studying for a major in Biology…
Read MoreFDA’s public meeting on February 24th left no uncertainty as to the future direction of drug development in rare disease: Patient-centric approaches that incorporate patient and caregiver input at all levels to ensure that clinical trial endpoints are robust and meaningful; and Utilization of patient data (registries, cases, natural history, and real world evidence) to…
Read MoreWhen you look at job descriptions for medical writers, have you noticed that, regardless of the size of the hiring company, you end up with an array of interpretations of the role? Here are some examples: Medical writers may or may not write briefing books, write or review labels, or assist in regulatory responses Medical…
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