Writing Sample

Working many years as an independent contractor is a testament to my ability as a medical writer. The documents I produce contain confidential information, and most of my clients prefer that I write in third person. So, for this writing sample, I decided to share a few thoughts about medical writing, which are not confidential, and use first person for a refreshing change.

I will not share all of my secrets, but collaborating with experts, tolerating ambiguity, and promoting good team review are among the strategies I use to produce effective clinical documents for regulatory submissions.

My job is to learn about new developments in medicine and communicate that information to an audience of experts. I am not an expert in the contents of the documents I prepare. It would be hard to find one person who is an expert in respiratory disease, infectious disease, cancer, heart disease, and pain management. Yet, I have prepared documents in each of those content areas. While I am not an expert in the contents of the documents, I am an expert at working as part of an interdisciplinary team and preparing documents in accordance with regulatory guidelines. The experts on the teams I collaborate with include physicians, statisticians, regulators, project managers, and clinical research associates. What I bring to the table is knowledge of the accepted outlines for documents to be submitted to regulatory authorities and medical journals and an aptitude for writing clearly.

At a DIA meeting a couple of years ago, a manager who hires medical writers talked about how to identify a good medical writer during the interview process. She said that a good medical writer is somebody who can tolerate ambiguity. At first, that may seem odd; but it resonated for me. Think of an end-of-phase 2 briefing document. The study drug may be called by different names in various study reports, depending on its stage of development. In early development, study drugs are identified by a number; if more than 1 company is involved over time, there may be several different numbers that refer to the same agent. As the clinical development process unfolds, if the agent appears to have potential as a new drug, a generic name is assigned. The medical writer struggles with the various names in the source documents, and if the medical writer wins, the resulting briefing document uses uniform terminology while providing links to the names used over the course of a drug’s development history.

When I send a draft document out for team review, I send an accompanying list of “points to consider” (ptc.doc) to help reviewers focus on things such as missing or conflicting information and unresolved questions. The ptc.doc specifies the section of the document to which each comment relates. This alerts the reviewers to key points in the draft that need their consideration. In addition, ptc.doc is useful in conducting document review meetings. It enables me to quickly identify outstanding issues to guide the discussion so that we make good use of the reviewers’ time in the meeting.

Thank you for visiting my website. If there is a good fit between your company's needs and my skills, I would be happy to hear from you.