Quick Answer: Pharmaceutical technical writing is a highly specialized discipline that directly impacts research outcomes, regulatory success, and business performance at pharmaceutical and biotech firms.
- Teams must communicate complex, high-stakes information credibly, clearly, and accurately.
- Poor writing can lead to 483s, warning letters, compliance issues, delayed approvals, and costly setbacks.
- General writing training isn’t enough: teams need instruction grounded in real pharmaceutical documents and real-world use cases.
The takeaway: strong pharmaceutical technical writing is a core capability, and building it requires targeted, domain-specific training.
Pharmaceutical technical writing sits in a category of its own
At first glance, it may seem similar to other forms of professional or scientific writing. In practice, however, it requires a far more specialized combination of skills, and the consequences of getting it wrong are significant.
Consider, for example, the expense and difficulty of R&D. Pharmaceutical and biotech firms must constantly make hard prioritization decisions (such as which R&D programs to pursue and which to close out) and satisfy a broad array of stakeholders with their results. Pharmaceutical technical writing in this area is thus vital for
- Assessing research value and outcomes
- Satisfying and gaining buy-in from stakeholders, from investors to regulators
- Sharing knowledge across the scientific community
In other words, writers in the pharmaceutical space must be informative, persuasive, succinct (respecting the reader’s time), and scientifically and technically credible, all at once. Then there’s another layer, too: writers have to be able to do all that for multiple types of readers, not all of whom will have the same background, informational needs, or technical understanding.
“Without prior [pharmaceutical] technical writing training, that was a challenge,” research and development associate Jennifer Paredes told us about her team’s own experience trying to produce such research reports at global biopharmaceutical company Celgene.
Why Pharmaceutical Technical Writing Is Different
The absence of specialized pharma and biotech technical writing skills leads to measurable problems.
A fascinating study published in the journal Current Medical Research and Opinion looked at the relationship between medical and pharmaceutical writing and publication retractions. One of the top-line findings was simply that a lack of medical writers was “significantly associated” with an increase in retractions (potentially damaging everything from credibility to future funding).
In practical terms, professional, subject-specific writers produce higher-quality documents that are more likely to be compliant.
In short, professionals who are tasked with writing documents in the pharma and life sciences fields aren’t trained writers, but they are subject matter experts; teaching them strategies to convey their expertise so that it’s readable and usable is crucial.
Documents such as regulatory submissions, deviation reports, root cause studies, standard operating procedures (SOPs), audit and inspection reports, and clinical research papers all carry serious weight. Each has defined expectations for structure, terminology, and supporting evidence, and those expectations vary depending on the environment in which the document will be reviewed and used. Problems here can trigger regulatory action, affect health or community outcomes, or delay approvals.
That last point alone can be extremely costly. One estimate suggests that every month of market access delay can cost $40 million in lost revenue for a pharmaceutical product with $500 million annual peak sales potential.
In other words, we aren’t talking about trivial consequences.
How to Build Pharmaceutical Technical Writing Skills
“A well-written manuscript enables readers, especially reviewers and editors, to easily grasp the scientific significance,” writes the European Society of Clinical Pharmacy in published guidance for writing pharmaceutical-related documents. “[But] writing a good manuscript is not easy, and there is no secret formula for success. Yet, publishing is a very rewarding endeavour [sic].”
When it comes to writing in this specialized field, part of what makes it “not easy” is that the basics of good writing are only the starting point. It’s not enough to find courses that focus only on how to write clear, readable, well-organized documents; the focus must be on the particular types of documents written in the industry.
Effective pharmaceutical writing programs immerse participants in industry-specific (and organization-specific) scenarios using realistic examples of real-world documents. Writing a research manuscript, a regulatory submission, or a standard operating procedure each requires a different approach, so it matters which documents get incorporated into the training. Writers must understand these nuances to produce documents that meet expectations.
For example, Paredes noted how the Hurley Write workshop was customized to align with their specific writing needs. “[The instructor] engaged the audience by using direct examples from our work,” she said.
The ideal writing course also addresses writing process and strategy challenges head-on. In the end, participants should know how to communicate complex scientific results clearly, maintain credibility, and meet the expectations and needs of everyone from regulators to investors to executive stakeholders. That’s a big task, but the right pharmaceutical technical writing workshop is the bridge between current capability and top performance.
If your team is responsible for producing high-stakes pharmaceutical documentation, developing domain-specific pharmaceutical technical writing skills is essential. We invite you to contact us for more information or explore our Writing for Biotech Professionals workshop to learn more about our pharmaceutical technical writing training.
Pharmaceutical Technical Writing FAQs
What is pharmaceutical technical writing?
Pharmaceutical technical writing refers to the creation of documents used in the development, production, and distribution of drugs, medical technology, and other pharmaceutical or biotech products. These documents include:
- Research papers
- Regulatory submissions
- Standard operating procedures (SOPs)
- Audit reports
- Deviation reports
- And far more
Unlike general business writing, pharmaceutical technical writing must meet strict standards for accuracy, structure, and compliance, while also communicating complex information clearly to a range of readers, from other experts to non-technical readers.
Why does pharmaceutical technical writing require specialized training?
Pharmaceutical technical writing operates in a highly regulated and high-stakes environment. Writers must understand how to write well and strategically, be able to structure documents according to industry expectations, communicate technical information accurately, and support decision-making across different stakeholder groups. General writing courses focus on fundamentals, but don’t address the specific document types, regulatory requirements, and communication challenges found in pharmaceutical and biotech settings.
What should you look for in a pharmaceutical technical writing course?
An effective pharmaceutical technical writing course should go beyond grammar and basic writing principles. It should incorporate your team’s real-world documents and reflect the actual conditions in which your team produces them. The best programs also tailor training to the individual organization’s needs, helping participants learn how to communicate complex scientific results clearly, maintain credibility, and meet the expectations of the regulators, stakeholders, and internal teams with which they work.
