To become a competent and successful medical writer, there are skills you must acquire.
If you are a life scientist, you likely have some of these under your belt. This includes an in-depth knowledge of science and research. This background is vital in industry, where you are expected to combine your knowledge of science and research, and present the information in a way your target audience will understand.
In one of my previous posts, I discussed the primary objectives of medical writing. In this blog post you’re reading, I’ll share some skills that are required from a medical writer.
Medical writing is a complicated process. So no single post can cover all the skills required. In fact, the changing landscape of the industry, forces a medical writer to stay current with industry guidelines. Thus, you must be self-motivated, humble, and eager to learn if you are to succeed in medical writing. If you are not a life scientist with an MD, PharmD or other degrees in the medical and health professions, you likely lack knowledge of medical (clinical) terminology.
Furthermore, most of us transitioning from academia to industry lack knowledge of regulatory terminology and their meaning.
What can I tell you now that I wish someone had told me then? Get some exposure to drug development and drug safety. Start learning the regulatory lingo. What is an IND? NDA? IDE? CTD? CMC? IB? CSR? What about an Orange Book? What are Guidance Documents?
The FDA website is a great place to start. The International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) have guidelines designed to provide a unified standard for the European Union, Japan, and the United States, in order to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
As a medical writer, you must write ICH and GCP-compliant documents. In academia, the publications we are accustomed to writing are usually short, and the style is often dictated by the journal. We can pick and choose, to some degree, what data to include in a manuscript.
Regulatory documents are documents within documents. The documents are much larger; the data is all-inclusive. In industry, an in-depth presentation of the data is inevitable. There are no short cuts. Data with complex statistical findings in tabular formats must be translated in a text format that is easily understood. If going through data in academia overwhelms you, then regulatory medical writing is not for you.
Writing in industry also involves a heavy use of style guides. The AMA Manual of Style likely covers all the style rules needed to complete most documents. For chemical references and abbreviations not included in the AMA Manual, the ACS Style Guide is practical. There are several other style guides that are utilized in medical writing, including guides designed by the company (in-house guides).
Such guides may include specific instructions on formatting and editing that must be followed. Although it may seem obvious, but learning to write well is one of the most important things you can do right now to prepare yourself for a career in medical writing.
As postdocs or medical school grads, we were not taught how to write. Some of us took advantage of the occasional workshops that our institutions offer. Take a brown bag lunch and attend these workshops.
Related to learning how to write, is finding your passion as a medical writer. As a biomedical researcher, your love for the bench may offset your dislike for writing. Not so in industry. You must be passionate about writing if you are to become a competent and successful medical writer. Some other qualifications and skills that make a good medical writer deserve a blog of their own. These will be highlighted in future posts. I’ll also share how you can enhance the skills you currently have so as to make yourself more marketable for industry.
Until then, “Happy Reading”