Five Tips for New Medical Writers
Medical writing can sometimes seem like a foreign language to someone new to the field. How can those who are newer to the medical writing world or to clinical development learn the basics? What helps them succeed?
Having been through the process of gaining familiarity with medical writing, I have found some solid strategies that can fast-track a person to better understanding.
Start with a good template – Working from a good template lays the foundation for success. Good templates literally show you the way to build a proper document by presenting helpful tips and relevant regulatory guidance. As a new medical writer, I have found templates to be a great learning tool.
Read your sources – Putting together a clinical study report? Thoroughly assimilating the protocol and the statistical analysis plan first will set you up for success. Drafting an update to an Investigator Brochure? Knowing what content needs to be updated from reference protocols or data outputs can help ensure accuracy. Using the source material as your guide means you have a better understanding of both the product and the end goal. Plus, the family of documents will be more consistent – it’s a win-win.
Dig into the data – Don’t be scared; they are only numbers. Taking inventory of the available data (tables, listings, and figures) will allow you to imagine what your finished product will include. For revisions and updates, you may notice familiar data presentations (having read your sources closely). For new documents, you will have a better sense of the scope of what is needed.
Shadow the QC process – An experienced QC reviewer/editor has a comprehensive grasp of how each document should be put together, including the document’s appearance and where to review for consistency. Are the changes in the synopsis captured in the body of the document? Is the version number changed in every header? These details can help a new medical writer understand how the document is organized and what pitfalls to avoid. The QC reviewer/editor and the medical writer are two sides of the same coin, and one set of skills complements the other.
Know and understand your writing platform - Knowing the software tools at your disposal will significantly increase your efficiency, and ensures formatting consistency throughout.
From my recent experience, there is a lot to learn as a medical writer who is new to the field; I have found that these tips and tricks accelerated my growth and development.
Editor / Associate Medical Writer
Acumen Medical Communications