Medical Writers Excel at More Than Just Writing

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, so there’s no room for creative writing! But good 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.

Good medical writers understand complex scientific concepts and write about them in a clear and concise way. But exceptional medical writers have two additional skills that are crucial but often overlooked – project management and strong communication.

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:

• You need to be persistent and have a thick skin. Chasing down reviewers to complete their document reviews is a fact of life for medical writers. You may be accused of being “annoying”, but making sure all of the required reviewers have completed their reviews on time is a part of your job.
• You need to be clear and firm in your communications. Impossibly tight timelines are the norm. You may receive intense pushback, so clearly and firmly articulate the reason for the tight timelines and keep the team informed of any changes as soon as possible.
• You need to know how to herd cats … or colleagues. Conflicting views between team members about a document may escalate, requiring medical writers to intervene, diffuse the situation, and help identify a solution.

To learn more about medical writing, here are some helpful resources:

American Medical Writers Association

Regulatory Affairs Professionals Society

Drug Information Association

Featured image from here.