Medical Writing & Pharma
When preparing regulatory submissions, especially in fields like oncology, it’s crucial to focus on the end goal—the drug’s label or Summary of Product Characteristics (SmPC). These documents aren’t just regulatory requirements; they serve as the foundation for how the drug will be positioned in the market. Writing with the label in mind means threading key…
Read MoreWriting is often thought of as a solitary task. An author sits in a quiet, isolated environment, plugging away with their thoughts. With regulatory writing, this couldn’t be further from the truth. Instead, it’s often a chaotic mix of emailing colleagues, coordinating timelines, and managing input from stakeholders. As a medical writer or project manager…
Read More
Prepare for a successful Quality Control review! Download this poster, presented by Synterex at the 2023 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version. Download this poster as a letter-size printable PDF Quality control (QC) specialists typically have an established process for reviewing documents, but the path will be…
Read More
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.
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More- « Previous
- 1
- 2
- 3
- Next »