Medical Writing & Pharma

Regulatory project management: keeping things on track

By pwsadmin / April 12, 2024 /

By Christine Iliff Writing 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…

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Your Document’s Path to a Successful Quality Control Review

By Synterex / October 25, 2023 / Comments Off on Your Document’s Path to a Successful Quality Control Review

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…

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Regulations in Blue Color on a White Background

ICH E6 (R3): Implications of Recent Updates for Medical Writers

By Synterex / June 8, 2023 / Comments Off on ICH E6 (R3): Implications of Recent Updates for Medical Writers

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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Person working on a document at a laptop

My Fellowship in Medical Writing: What I Learned

By Synterex / May 19, 2023 / Comments Off on My Fellowship in Medical Writing: What I Learned

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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A Snippet of a Prompt from Chat GPT

Hey ChatGPT? Tell Me a Story

By Jeanette Towles / January 15, 2023 / Comments Off on Hey ChatGPT? Tell Me a Story

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 education poster graphic

Building a Training Curriculum for Business Education

By Synterex / November 2, 2022 / Comments Off on Building a Training Curriculum for Business Education

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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Dealing difficult people poster graphic

Dealing with Difficult People

By Synterex / November 2, 2022 / Comments Off on Dealing with Difficult People

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 for medical writers poster

Checklists for Medical Writers

By Synterex / November 2, 2022 / Comments Off on Checklists for Medical Writers

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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Project manager with laptop, phone, and planner

What Does a Regulatory Project Manager Do?

By Synterex / August 31, 2022 / Comments Off on What Does a Regulatory Project Manager Do?

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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Headshots of Katelyn and Alex

Meet Synterex’s 2022 Medical Writing Internship/Fellowship Recipients

By Synterex / June 22, 2022 / Comments Off on Meet Synterex’s 2022 Medical Writing Internship/Fellowship Recipients

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…

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