NeuAge Institute (NAI)

Pharmaceutical Regulatory Affairs: 5 Ways to Improve Your Technical Writing Skills

Getting started in a career in the pharmaceutical industry is an exciting time for anyone, no matter your previous work experience. At the NeuAge Institute, we have both Continuing Education Modules and Certificate Programs that allow learners from all levels of expertise to reach their career goals.

With NAI online learning, you’ll be able to specialize in your area of interest with a flexible program structure that caters to your schedule. If you’re looking into a specialization in regulatory affairs, then you’ll be thrilled with the NAI’s engaging and interactive online learning platform that will help you gain the skills you need through an applied and practical approach. Take a look below at our top five tips for technical writing, an essential component of any regulatory affairs role.

1. Lead with Clarity 

For every sentence you write, you want to lead with clarity, making this your number one goal. This way, no matter who is reading, every audience member will draw the same conclusion from your writings. 

To best implement clear and direct writing, avoid nondescript words or vague phrases that can be interpreted differently by different people, such as “some, often, many, very,” and instead use exact values, time frames, etc., which you’ll become familiar with during your pharmaceutical regulations certificate program.

2. Stay Concise with Pharmaceutical Regulatory Affairs Writing

Because your pharmaceutical regulatory affairs writing should be aimed at helping your reader understand, you want to make sure that it stays concise. Avoid bringing up any issues or problems that may arise from your findings, and instead simply present the information in a direct manner.

Best practices include avoiding the use of unnecessarily complicated vocabulary, multisyllabic words, redundancy, and the passive voice. Addressing the subject at the beginning of each sentence, instead of hidden somewhere within the text, can also help you stay concise. 

regulatory affairs courses
Pharmaceutical regulatory affairs documents are best received when they are clear and concise

3. Design the Document to Appeal to the Reader

Technical writing is easier and more pleasant to read when it is broken up into smaller sections of text, as opposed to long, unbroken paragraphs. Any time you change the subject slightly or introduce a new point is a great time to start a new paragraph.

Breaking up the text creates a more visually appealing document, and will help your readers absorb the information easier in sections at a time. 

4. Speak to Your Audience

Depending on the document you are creating, you may need to speak to different audiences. In the Introduction to Quality Documents and Technical Writing course at the NAI, you can expect to learn how to develop Standard Operating Procedures (SOP), process flowcharts, audit responses, change controls, stability documents, and deviations.

pharmaceutical regulatory affairs
Making sure you are providing value to your audience with the necessary information can help you improve your technical writing skills

Practice with each of these types of documents will help you understand who you are writing to and what information you need to get across. It can be helpful to ask the following questions about your reader:

  • What do they know already?
  • What do they need to find out?
  • How is this information useful for them?

In addition, you should be sure to spell out any abbreviations the first time they are used to reinforce clarity.

5. Maintain Accuracy Above Everything

Accuracy is essential in these important regulatory affairs documents that you may be creating during your pharmaceutical career. Accuracy ensures that your document is a reliable source of information and adds to your professionalism. 

To implement accuracy in your writing, be sure to use relevant statistics, cite your sources, proofread your documents, and send them to a peer or colleague for additional editing. All of these steps can help ensure that you find success as you enter the pharmaceutical industry as a technical writer, no matter your experience level.

Interested in starting regulatory affairs courses

Contact the NeuAge Institute for more information!




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