Bringing a pharmaceutical product or medical device to market involves many different phases. Along the way, one of the most important components is developing documents that are often required by law. This means a medical writer must have knowledge of the industry and expertise as a writer. They must be adept at following guidelines and adhering to regulations. There’s also the importance of accuracy and being able to collaborate with other members of the project team. Below are four important considerations when choosing a medical writer that are designed to help you select the best candidate.
1. Industry Expertise
Writing about anything requires an understanding of the target audience. This is because the writer will need to develop the right tone. When choosing a medical writer, one of the required qualifications is their ability to develop the correct regulatory tone, which means they must have experience in this area. Writers that excel at regulatory tone do so because they have expertise in then industry and understand what’s required so that the language appeals to all stakeholders, especially patients.
2. Accuracy Rate
The experience level of a medical writer will give them the background needed to understand issues like formatting, style and consistency. These are all critical elements of medical writing. As with writing in any other industry, accuracy is important. However, in medical writing there is a far greater urgency when it comes to ensuring keen attention to detail and reducing the error rate. This is important because mistakes can literally affect the timeline, extend review cycles and delay the go-to-market schedule. On the flip side, a medical writer that’s knowledgeable can accelerate the process by reducing the amount of time it takes to get through the approval process.
3. Project Schedule
Unless you’re working with an in-house medical writer that’s full-time, you’ll need to vet the candidate based on their availability. When you have a project with a strict timeline, you can’t afford to wait for the submission of documents outside of the defined schedule. You need to find a writer that’s available and trustworthy. This means you’ll have to get recommendations to confirm their ability to submit work on time. Project delays are costly and can create significant problems. As you probably know, working on a project that requires a medical writer can be complicated because of the many regulations governing the marketing of pharmaceuticals and medical devices. If you are unable to find someone with the right availability, you might consider outsourcing the role.
4. Post-Launch Support
Beyond the clear need to ensure the writer is knowledgeable, competent and available to bring a product to market, there’s also the need to ensure they are available for work post-launch. The need to develop documents does not end when a product goes to market. There is a need for a writer throughout the product lifecycle. Trying to work with a new writer later in the process can become a nightmare because of the learning curve and the amount of time it can take to get up to speed. While there are times when it works out, that’s usually because you’re working with a writer that has deep knowledge and experience.
The bottom line is that a medical writer must be well-rounded in their ability to communicate effectively, satisfy regulations, work cooperatively with project teams and ensure a high level of accuracy. While this sounds like a tall order, it is a known expectation. Generally speaking, the fact that literature about the product is often available enables the writer to get up to speed. A writer that has broad and rich experience in the industry will understand the necessary style and be able to pivot where necessary.
If you are unable to identify a writer with the qualifications that you seek, you can always opt for a medical writing service because there’s a better chance of finding someone that has the knowledge and skills required to achieve the desired outcomes. Given what’s at stake, it makes sense to get help identifying the most qualified writer available at a price that fits within the project budget.