At the 2025 European Medical Writers Association (EMWA) Conference in Riga, we caught up with two experienced medical writers, Sabrina Stöhr (Associate Director of Medical Writing Operations and Processes at Merck) and Katrin Zaragoza (Regulatory Writing Mentor at Medrika Academy), following their workshop on writing effective Briefing Documents for regulatory submissions. They also shared their insights on the growing importance of outsourced medical writing within the industry.
We spent our time with Sabrina and Katrin discussing their perspectives on how biotech teams can approach outsourcing their medical writing needs to achieve efficient processes and high-quality submissions.
What follows are Sabrina and Katrin’s insights as well as our own team’s perspectives on what biotechs can do to set their next medical writing project up for success.
Choose the right partner: freelancers vs CROs
Once you have decided to outsource writing your clinical or regulatory documents, the first step is to determine the kind of organization to partner with. The two main choices are Freelance Medical Writers or large CROs, both of which offer a very different experience.
Both Sabrina and Katrin recommend prioritizing Freelance Medical Writers, especially for smaller biotechs. As Sabrina says, “You’ll get more tailored, direct collaboration.” Katrin added, “Often, the best freelancers are ones you identify personally and bring into the vendor system.”
Of course, managing multiple freelancers can be a challenge for smaller teams. That’s when it can be beneficial to work with a medical writing partner that combines the specialized experience of Freelance Medical Writers with an in-house team of Project Managers and Quality Control Specialists to streamline communication and ensure timelines are met without adding to your team’s workload.
Find a Medical Writer with the right skills and experience
If you do decide to partner with a Freelance Medical Writer, it’s important to find one whose skills and experience are right for your needs.
Technical experience and expertise
All Medical Writers have different strengths and expertise that lend themselves to different projects. When speaking with potential writers, ask about their experience writing the documents you need and in your therapeutic area.
Working with a Medical Writer with relevant experience can reduce time spent briefing and the rounds of review needed before receiving a final draft, speeding up the process and leading to greater efficiencies.
Soft skills
As well as technical expertise, both Sabrina and Katrin emphasize the importance of soft skills like communication.
Sabrina advises, “Look for an experienced Consultant Medical Writer who has the maturity to lead the document development. Someone who is strong in communication and bold enough to say no.” Katrin echoes this sentiment, saying, “They need to be confident enough to challenge and should not be shy. It’s important that they lead and are diplomatic.”
It can also be beneficial to look for a Medical Writer with a proven ability to manage complex timelines and stakeholder input. Although again, working with a dedicated Project Manager allows Medical Writers to focus purely on producing your documents without distraction.
When experience isn’t available, what else counts?
Sometimes, it’s not possible to source a Medical Writer with experience that exactly matches your therapeutic area and document(s). In this case, both Sabrina and Katrin agree that some other regulatory documents require the cross-functional coordination needed to provide a strong basis for many other documents.
Sabrina and Katrin gave the example of looking for a writer to support with a Briefing Book. If the available writers don’t have direct experience, other documents provide a strong basis. In this case, Sabrina says, “Writing Investigator’s Brochures or Protocols is great preparation due to their cross-functional nature.” Katrin agrees, adding, “Study Plans also provide relevant exposure.”
