By Penelope Przekop, MSQA, RQAP-GCP
In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success . I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.” I dedicated bits and pieces of my free time over the next five years to writing my first novel. During that time, I wasn’t focused on how improving my writing skills might impact my pharma industry career, which was well underway. Now, I know firsthand that all those high school and college English, writing, and literature teachers and professors were right when they told us that excellent writing skills can take us far in any career.
You may have guessed that my novels have not yet made the New York Times Best Seller list, and that’s okay! The tremendous impact on my pharma career has been a wonderful payoff for all those minutes, hours, days, and years I slaved away on my novels. So why am I telling you all this? No, I’m not here to sell you a book. I’ve decided to share some issues that I consistently see in my consulting work regarding writing standard operating procedures (SOPs), along with some tips for improvement. I hope you will value my opinion not only as a seasoned pharma industry quality and compliance-focused consultant but also as a writer.
The medical writing professionals in our industry develop excellent documents, and their ability to do so is highly supported across the industry. Yet I’m often surprised at the lack of priority that writing skills receive when it comes to SOPs. During audits, mock inspections, and gap assessments, I read SOPs to gain an understanding of organizational processes, who is responsible to do what, what the steps and handoffs are, how execution of regulatory requirements is incorporated, etc. Many of the SOPs I read are well written; I get excited when that happens. But many display writing skills that fall below what one might expect from the highly educated people executing the whole, complex shebang.
- Is this because those who gravitate toward STEM fields don’t particularly enjoy writing? But is that me labeling people? That feels like a fixed mind-set on my part, which I fight.
- Is it because all these highly educated people are simply too busy to focus on the power of the written word? I understand and can relate to this, but the “words” document all the work that they’ve done, are doing, and will do. According to regulators, if it isn’t documented, it didn’t happen.
- If the SOPs I’m reading today are illogical, have poor sentence structure, inconsistent formatting, vague and/or sometimes inaccurate word choices, poor chronological order, etc., how will they provide clarity and confidence to a regulatory inspector?
- How will anyone be able to explain what happened should something go wrong down the line?
So, what is a STEM-minded person who may not be particularly interested or passionate about writing to do? I’m 99 percent sure that if you apply the three tips below, your writing, and your SOPs, will improve.
1. Write tight.
When you write a sentence, ask yourself, “Can I make this point using fewer words?” Most people use unnecessary words when writing. Wordiness can dilute your message and cause confusion and misinterpretation.
1.1 The manager of the regulatory affairs department or their assigned backup will attend the project team meeting after the project has been finalized and will make sure that all of the employees involved have completed their work in the diligent manner for which they were expected to do so as well as on time.
Regulatory Affairs Manager or Designee
1.1 At the final project meeting, verify that all team member assignments were completed on time and met expectations.
2. Avoid redundancy.
Redundancy in writing is often how all those extra words get tossed in. It also contributes to a lack of clarity.
1.1 The project team for the clinical research project should determine, decide, and document whether or not the project team will perform the duties and tasks required by regulatory authorities for the project, or if the project team will outsource the duties and tasks that need to be completed for the project.
Clinical Project Team Leader or Designee
1.1 Document outsourcing decisions and delegation of regulatory requirements in applicable contracts, quality agreements, etc.
3. Use active voice.
The easiest way to think about this is to focus on beginning all sentences that describe an action with an action word. This is easier to do if you can specify the responsible role outside of the actual action steps as shown in the examples above. This increases clarity, so the reader knows exactly what to do and who will do it. In the example below, all action words are in bold to provide additional clarity on active voice. The first example is written using a passive voice. In the alternative example, you also see an additional illustration of writing tight, avoiding redundancy, and using chronological order.
1.1 It’s important to document approval of the revised Study Management Plan (SMP) and this is an important regulatory step for the organization. In this case, the Director of Clinical Development or someone within the project team who has appropriate authority should be sure to review and approve it as quickly as possible given other priorities, taking care to review the document in its entirety and ultimately sign the final version. The project team member who has appropriate responsibility should revise the document, as needed. If issues are identified, those should be provided to that person.
Director of Clinical Development or Designee
- Review the final Study Management Plan (SMP) within an agreed time frame based on project priorities.
- Provide review comments to the Clinical Project Lead or Designee, as applicable.
Clinical Project Lead or Designee
- Address all comments and provide the revised SMP to the Director of Clinical Development or Designee within five (5) working days.
Director of Clinical Development or Designee
- Review the revised SMP within an agreed time frame based on project priorities. Continue the review cycle, as needed, until all comments are addressed.
- Approve the final SMP.
If you find yourself thinking that the examples above must be exaggerated … trust me! These are real-life examples from my consulting work. Regardless of where you fall on the writing skill bell curve, applying the three tips above can take your writing, and your SOPs, to the next level. Now get busy writing! This writing nerd loves a beautifully written SOP, and so do global regulators.
About The Author:
Penelope Przekop, MSQA, RQAP-GCP, partners with pharma and biotech companies of all sizes to develop risk-based strategic solutions for establishing (or enhancing) clinical and pharmacovigilance quality systems that support growth and ensure long-term compliance. She is a global GXP quality systems/assurance and regulatory compliance consultant with 25-plus years of industry experience. Her areas of expertise include strategy development, quality systems and assurance, inspection readiness, and organizational training. She frequently conducts regulatory mock inspections and develops outcomes-based inspection readiness strategies.
Przekop earned a B.S. in biological sciences from Louisiana State University and an M.S. in quality assurance/systems engineering from Kennesaw State University. She has held leadership positions in both Big Pharma and CROs, including Novartis, Covance, Wyeth, and Johnson & Johnson. She is the author of Six Sigma for Business Excellence (McGraw-Hill).