Thought leadership
In today’s fast-evolving digital landscape, digital employee experience (DEx) is more than just a buzzword—it’s an essential aspect of organizational success, particularly for professionals like medical writers. DEx refers to how employees interact with the tools and technologies provided by their employer, from software applications and hardware to online services and platforms. For medical writers,…
Read MoreAs clinical trials evolve in the digital age, e-consent has emerged as a promising tool to enhance patient engagement, streamline processes, and improve regulatory compliance. While the benefits of e-consent are significant, implementing this technology also presents several challenges that sponsors and clinical teams must navigate. Below, we’ll explore both the benefits and challenges of…
Read MoreLean authoring, a method popularized by medical writing expert Gregory Cuppan, emphasizes streamlined, focused writing that delivers key messages without unnecessary detail. It promises efficiency, but the reality of implementing lean authoring within a cross-functional team often involves substantial negotiation. Lean authoring becomes not a black-or-white process but, rather, an exercise in grayscale methodology. This…
Read MoreFor a drug to get on the market in the United States, it must go through a rigorous review by FDA’s Center for Drug Evaluation and Research (CDER) (or, in some cases, the Center for Biologics Evaluation and Research [CBER]). Drugs are tested in preclinical and then in clinical settings to assess safety and efficacy.…
Read MoreManaging information requests from health authorities such as the FDA is a critical aspect of regulatory compliance for pharmaceutical companies. These interactions can directly affect the pace of your product’s approval process. To succeed, it’s important to follow best practices that focus on clarity, accuracy, and efficient project management. A key component to success is…
Read MoreAs Americans, we tend to be very insular in our thinking. Since we don’t generally need to know another language, most of us don’t understand anything but English. Since we typically have far fewer vacation days than other countries, our vacations tend to be short. Our travels are likely to be something like a week…
Read MoreIn the realm of medical writing, titles like “regulatory” or “pharma” may take center stage, overshadowing the less emphasized term “ethical medical writer.” This isn’t a downplaying of significance but a recognition that ethical considerations are the cornerstone of every medical writer’s practice. Ethical conduct is an unspoken yet powerful expectation and obligation. Each medical…
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We’ve all seen a lot of articles in the last few years about the pros and cons of the remote work environment. Regardless of whether they’re written by someone who is happier and more productive working from home, or by someone who insists everyone simply must be forced back into the office, I have noticed…
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By Karen Cross Simple reminders to sit up straight, stand tall, stretch and be aware of body alignment Many side effects can result from poor posture: shoulder, neck and back pain, circulation issues, dizziness and even depression, to name a few. You can avoid injuries and unnecessary doctor visits and save your time and money…
Read MorePronoun conversations are popping up all over; and, luckily, they’re spreading to the workplace, too. As pronouns are deeply personal, it’s important that this part of a person’s identity is both respected and accepted at work. To start any new work (or personal) relationship off on the right foot, introduce yourself with your name and…
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