Why Nancy Singer is still passionate about helping regulatory professionals communicate better

Nancy Singer is a RAPS Fellow and is one of the presenters at the RAPS Advanced Strategic Communications Certificate Program. We chatted with her about her unique career journey and why she remains committed to helping regulatory and quality professionals improve their communication skills. 

You started your career in the regulatory arena as a federal prosecutor representing FDA for the US Department of Justice, where you never lost a case. What aspects of this role shaped your career? 

One of the most important things I learned was the power of the written word. In litigation, words are taken literally. A sarcastic email, a cryptic note, or something written in frustration can look very different when it is taken out of context and presented to a jury. 

I won cases by asking witnesses to read their own words aloud in court. That had an impact on me. When I left the government, I wanted people in industry to understand something I had seen firsthand: seemingly harmless statements can become powerful evidence in litigation. 

That experience led me to create Dangerous Documents: Avoiding Land Mines in Records and Emails, a course I have taught to both FDA staff and industry professionals. 

After DOJ, you spent time at a law firm, as executive director at the Food and Drug Law Institute, and at AdvaMed as executive director of Medical Technology Learning Institute and special counsel. How did these experiences draw you to RAPS, where you earned your RAC and served on our board of directors? 

As executive director of the Food and Drug Law Institute, I worked with many attorneys in FDA-regulated companies. Later, as I began working more closely with regulatory professionals, I was impressed by how practical they were. They understood the law, but they also understood how FDA requirements actually had to be implemented within a company. 

While I was in private practice, I became involved with RAPS by helping organize educational programs that brought FDA officials together with regulatory professionals. I also made a point of giving younger regulatory professionals opportunities to participate and become more visible, especially women. At that time, women were not always given the professional recognition they deserved. Society has made great strides since then, even if we still can keep improving. 

Over the years, I became increasingly involved with RAPS. I earned my RAC and later served on the committee that developed RAC examinations. I became a RAPS Fellow, served on the Fellows Selection Committee, chaired the DC/Baltimore Chapter, spoke at chapter programs and RAPS Convergences, and ultimately served on the RAPS Board of Directors. 

RAPS gave me an opportunity not only to be part of the regulatory profession, but also to help other regulatory professionals grow in their careers. 

For decades, you have led workshops with RAPS and other organizations that focus on what you call “power skills” including communication and documentation. What led you to focus on these areas? 

Throughout my career, I was often the first woman in a particular role. There wasn't always someone ahead of me showing me what to do. I made mistakes, learned from them, and figured out techniques that helped me become more effective. 

I wanted to share what I had learned so others wouldn't have to make some of the same mistakes. That is really what drew me to teaching communication and other power skills. 

I have learned that technical knowledge may get you into the room, but being able to communicate determines whether people listen to your ideas once you are there. 

Where do regulatory affairs professionals often fall short when it comes to communication? 

Regulatory professionals are extremely knowledgeable. Sometimes that actually creates a communication problem. 

When someone asks them a question, they naturally want to share everything they know. But that is often not what a senior executive wants. The executive wants to know: What do I need to know? Why does it matter? What do you recommend? 

When we give people too much detail, the important message can get lost. 

I also think regulatory professionals need to understand the business side of their organizations. It isn't enough to know whether a proposed solution meets regulatory requirements. They also need to understand the financial and operational consequences of what they are recommending. 

The regulatory professionals who do this well are more likely to be viewed not simply as regulatory experts, but as people who senior management want involved when important business decisions are being made. 

The RAPS Advanced Strategic Communications Certificate Program starts off with Avoiding Disastrous Mistakes When Briefing High-Level Agency Officials, a session that has attendees rehearse a real-world scenario where their company’s primary product is experiencing reports of adverse events not observed in clinical studies. Where did the inspiration for sessions like this come from? 

The scenarios come from situations that regulatory professionals actually face. 

I teach the program with Richard DeRisio, who, after a ten-year career in FDA headquarters, held senior positions at companies including Pfizer, Abbott, J&J, and Covidien, and Rosanne Melikian, whose career history includes senior regulatory positions at Abbott Medical Optics and J&J MedTech, her current employer.   

During our careers, all three of us have either been in these difficult situations ourselves or watched colleagues deal with them. We use what we have learned from those experiences in the program. 

We don't just tell participants what they should do. We put them in a realistic situation and ask, “What would you actually say?” 

Knowing a communication principle is one thing. Finding the right words when an FDA official or senior executive is sitting across the table waiting for an answer is quite another. We want people to have a chance to practice before they find themselves in that situation for real. 

How did you decide to partner up with Richard DeRisio and Rosanne Melikian for this workshop, and what perspectives do they bring? 

I consider Richard DeRisio and Rosanne Melikian to be among the best regulatory professionals I know, and I am honored to teach with them. 

Richard and Rosanne have spent much of their careers dealing directly with complex regulatory issues inside major healthcare companies. I come to these issues from a somewhat different direction because of my experience as an FDA prosecutor, private-practice attorney, association executive, and educator. 

We don't always look at a problem in exactly the same way. I like that. Participants get to hear three experienced people discuss a difficult situation and sometimes approach it differently. 

That is much closer to what happens in real life. There usually isn't a perfect script for a difficult conversation. You need to understand the people you are talking to, use good judgment, and decide what will be most effective in that situation.