Hiring the Right Medical Writer

Hiring the Right Medical Writer

In the regulated world of pharmaceuticals and medical devices, clear and effective communication is everything. From regulatory documents to clinical trial reports and marketing materials, the quality of medical writing directly impacts a company's success. That’s why hiring the right medical writer is crucial. While a strong grasp of the science and the ability to distill complex concepts into clear, concise language are essential, these alone are not enough. Soft skills—like adaptability, collaboration, and communication—and strong project management abilities are equally critical. Most hiring missteps stem from gaps in these areas, which are vital for meeting deadlines, navigating regulatory complexities, and working effectively within multidisciplinary teams. Here’s what you should consider when selecting a medical writer for your team.

1. Background and Experience

The ideal medical writer should be knowledgeable about the subject matter but also skilled in the writing process. A strong background in life sciences, medicine, or healthcare is essential for understanding the complexities of clinical data. A degree in medicine, pharmacy, life sciences, or nursing lays the foundation for understanding the science behind the words.

However, expertise in science alone is not enough. The medical writer must also excel at distilling and presenting complex data and research into clear, accessible content.

Here’s what to look for:

• Strong and relevant academic qualifications (e.g., PhD, MD, MSc, PharmD)

• Proven experience in medical writing, including regulatory submissions, clinical trial documentation, or patient-facing materials

• Familiarity with industry-specific terminology and standards (e.g., ICH-GCP, ISO, FDA guidelines)

• In-depth knowledge of governing regulations (e.g., EU MDR, FDA)

Finding a writer with the right combination of science and writing expertise is key to delivering high-quality, compliant medical content.

2. Demonstrated Ability: Writing Test

Where there are doubts about a candidate’s writing abilities it can be helpful to gauge a medical writer’s capability through a writing test. This allows you to assess their ability to quickly synthesize information, maintain clarity, and follow the specific structure and tone required for the task at hand. Whether the test requires drafting a section of a clinical study report, summarizing a scientific journal article, or working with a patient leaflet, it should be aligned with the type of writing you need for your project.

A writing test helps evaluate:

• Their ability to communicate complex information clearly while following instructions

• Proficiency in researching, organizing, interpreting, and present data

• Their ability to produce a well formatted document

• Attention to detail, especially in terms of accuracy and consistency

• Their efficiency in completing the task within a set amount of time

This hands-on approach is crucial for ensuring your writer can meet the demands of your project with precision and professionalism.

3. Project Management Skills

In medical writing, the ability to manage multiple tasks, deadlines, and stakeholders is critical. Writers often juggle several projects simultaneously, from writing and editing to coordinating with subject matter experts (SMEs) and regulatory agencies. To stay on top of it all, a writer must have strong project management skills, especially when handling tight deadlines or shifting priorities.

Look for candidates who demonstrate:

• Strong organizational skills to handle multiple documents or projects at once

• The ability to prioritize effectively, ensuring critical tasks are completed on time

• A proactive approach to managing communication between internal teams, regulatory bodies, and other stakeholders

• Strong initiative to move projects forward including follow up with functional experts and communication of project status and risks to timelines

• Creative problem-solving mentality to develop and communicate proposed solutions for project challenges

• Experience with project management tools or software, if applicable

These skills are essential for ensuring that projects are completed efficiently and on schedule.

4. Soft Skills: Communication, Adaptability, and Collaboration

In medical writing, soft skills are just as important as technical skills. Medical writers must communicate clearly with a wide range of stakeholders, including researchers, doctors, regulatory experts, and non-scientific audiences. The ability to adapt their writing style to different audiences is key, whether producing a peer-reviewed journal, an FDA submission, or a patient-facing brochure.

Consider these soft skills during the hiring process:

• Communication: A medical writer must be able to engage in discussions with experts, understand complex medical information, and translate it into clear, concise writing.

• Adaptability: The medical writing landscape is constantly evolving, especially with advances in medical science and shifting regulatory requirements. The right candidate will be flexible and ready to embrace new technologies and standards.

• Leadership: A medical writer must be able to effectively lead a team of functional experts required to support document development. This often includes planning and leading key meetings to support messaging alignment across a team of diverse functional experts.

• Collaboration: Successful medical writing requires seamless teamwork. Look for candidates with strong interpersonal skills who will work well within a diverse team.

• Attention to Detail: Medical writing is a precise task where accuracy is non-negotiable. A keen eye for detail ensures that no errors slip through, particularly in documents that are subject to regulatory review.

These soft skills are crucial for ensuring a medical writer can thrive in dynamic, multidisciplinary environments and produce accurate, high-quality content.

Conclusion

Hiring the right medical writer is a multifaceted process that requires a balanced evaluation of technical expertise, demonstrated ability, project management acumen, and essential soft skills. By carefully considering a candidate’s background, testing their writing abilities, assessing their project management experience, and ensuring they excel in communication and collaboration, you will feel confident that your medical writing projects are in capable hands. With the right medical writer on your team, you can effectively navigate the complexities of medical documentation and communicate critical information with precision and clarity.

Partner with Dependable Experts While You Build Your Team

Finding the right medical writer takes time, but your projects can’t wait. Our team of experienced regulatory writers and consultants is here to provide the support you need while you staff up. Whether it’s regulatory submissions, project management, or individualized training we deliver high-quality, compliant content to keep your projects on track.

Let us be your trusted partner during this transition—ensuring clarity, precision, and expertise in every deliverable.

Contact us today to learn how our writing and consulting services can bridge the gap and support your team!

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