Medical writers in the biopharmaceutical industry write and edit regulatory documents that support the development and approval of new medicines. These documents strictly adhere to the regulations of different health authorities around the world. There’s no room for creative writing! But medical writers need skills beyond good grammar, punctuation, and style.
Write Clear, Concise, and Accurate Documents
Regulatory documents are technical and complex, because they present everything that is known about a medicine – from its molecular structure and physical properties to clinical trial data indicating whether it is safe and effective in patients with specific diseases. They are submitted to global health authorities at key points in a medicine’s development lifecycle in hopes of eventually becoming an approved treatment for patients. The information presented in these documents must be clear, concise, and accurate. Some examples include:
- Clinical study protocol – a roadmap for testing medicines in patients
- Investigator brochure – an annual status update of the program, including nonclinical and clinical studies
- Clinical study report – a summary of clinical trial results
- Health authority submission – the cumulative summary of a medicine to obtain marketing approval
Synthesize Data and Summarize Key Messages
Seems easy, right? Well, not really. Most of the new medicines being developed are based on cutting-edge science – new technologies that the medical writer needs to understand and describe clearly and accurately. The writer has to review and summarize voluminous amounts of nonclinical and clinical data and identify key trends to support the future approval of the medicine for patients. Most documents are more than 100 pages long and filled with text, tables, and figures!
But importantly, medical writers aren’t just reviewing and writing – they are at the center of a cross-functional team of experts from clinical development, operations, research, translational medicine, drug safety, and biostatistics.
Manage Complex Projects and Communicate Well
Every document is a project that requires input from a team of experts. It is up to the medical writer to bring these cross-functional experts together, keep the project on track by managing the overall timeline and document review process, and promptly communicate any obstacles that may occur along the way. Sometimes challenges arise, so here are some observations:
- A reminder to complete a review as soon as possible may be interpreted as “annoying”, so a thick skin is helpful.
- An impossibly tight timeline may elicit intense pushback from the team, so the ability to clearly and firmly articulate the reason for the timeline (or other issue) is critical.
- Conflicting views between team members during a comment adjudication meeting may escalate, requiring medical writers to intervene, diffuse the situation, and keep the meeting on track.
To learn more about medical writing, here are some helpful resources:
American Medical Writers Association
Regulatory Affairs Professionals Society
Featured image from here.