The economic fallout from the COVID‑19 pandemic has affected thousands of career paths, including many in the medical communication field. Whether you’re seeking new remote work opportunities or hoping to expand your skill set to further advance your career, consider pursuing writing in the pharmaceutical industry.
Let’s explore the distinct types of writing in this niche, then identify the challenges you must overcome to succeed as a writer in this rapidly expanding industry.
Types of Writing for the Pharmaceutical Industry
If you’re a veteran medical writer, you already have a solid understanding of these broad types of medical writing:
- Regulatory writing
- Scientific publications
- Health communications
- Education for professionals
- Promotional writing
- Grantsmanship
Whether you write for a pharmaceutical company, medical device company, or some other type of organization, pharmaceutical content can fall into several of the above categories.
Writers for the pharmaceutical industry are likely to do one (or more) of the following types of writing, which are further described in The Writing Cooperative’s “Writing for the Pharmaceutical Industry”:
- Pharmaceutical marketing communications. Medical drugs and devices are marketed to consumers and health care professionals. As a medical marketing communicator, you’ll need to write plain language summaries of critical information—from drug contraindications to clear indications for use. You will also craft content such as slide decks and brochures to educate physicians about these products.
If you work for a health care organization rather than a drug or medical device company, you might create content for the hospital’s website, newsletter, or other marketing materials. - Regulatory writing. Writers in this niche focus on documents required by regulatory agencies such as the FDA’s Center for Drug Evaluation and Research (CDER).
You could write manuals for conducting clinical trials (known as investigator brochures), clinical study reports, or submissions such as Investigational New Drug Applications (INDs), Marketing Authorization Applications (MAAs), or New Drug Applications (NDAs). - Continuing medical education (CME) course writing. Like professionals in other industries, doctors, nurses, and other medical professionals must earn continuing education credits to maintain their licenses. Writing content for these courses is a lucrative, rewarding option for medical communicators with a love for learning.
- Technical writing. Pharmaceutical technical writers create technical documentation such as medical device user manuals or reference guides. This type of writing requires incredible attention to detail.
The writing can seem dry—especially for those shifting from health communication or medical marketing—but a great technical writer can also enjoy the satisfaction of translating dense information into helpful material for a variety of readers.
Challenges of Writing for the Pharmaceutical Industry
The pharmaceutical field is increasingly fast‑paced. From novel drugs to the development of generic specialty medications, the rapid changes can feel overwhelming for medical writers who must keep up with changing trends and regulations.
Here are some of the greatest challenges of crafting documents for this industry:
Lack of standardized training
The baseline experience of regulatory writers is uneven or absent due to the lack of formal, standardized training in many organizations. Regulatory writer training is necessary, but it’s difficult to create because it consists of so many components, including hands‑on education. Extensive training also takes place over multiple years.
Writers for the pharmaceutical industry—especially those involved in regulatory document creation—should have the following:
- High‑level knowledge of the drug development process
- Strong medical writing skills
- Technical aptitude with a variety of resources, from Adobe Acrobat to Clinical Data Interchange Standards Consortium (CDISC) Glossary
AMWA’s training roadmap for regulatory writers offers a helpful outline of the regulatory topics that are most important and demonstrates how certain topics and skills build on the preceding ones.
Rapidly evolving therapies and standards
Addressing this challenge requires a deep commitment to continued learning. In Managed Care Executive’s January article “Top Issues Facing Pharma in 2020,” author Frieda Wiley, PharmD, reviewed several hot-button topics in the pharmaceutical industry’s “era of exponential change.”
In this industry, you might write about a variety of therapeutic categories with new products every year. You could find yourself creating documents covering everything from gene therapy to specialty drugs for rare diseases and disorders. You should also be prepared for last‑minute document revisions due to late‑breaking study results or urgent regulatory changes.
Attention to detail
Writing for the pharmaceutical industry is not for everyone. Writers must be fastidious and undistracted—even when the topics are highly technical or dry.
The pharmaceutical industry can be challenging even for experienced medical writers. The key is to commit to learning, maintain unwavering attention to detail, and determine a niche that maximizes your background and skills.
