Medical writers are experts at writing detailed scientific documents geared toward scientists, clinicians, and regulatory agencies. However, sometimes we are asked to prepare documents for a lay audience. These can include lay summaries of clinical study reports, informed consent forms, or other patient education materials.

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.

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.

We asked ChatGPT to tell us a story about a medical writer; here’s what it got right and what it got wrong.

Crawl technology is a valuable tool for content curation. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version.

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.

<p>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&hellip;</p>

<p>FDA’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) </p>

<p>When 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 </p>