Interview with Dr. Keagen Hadley – Episode 444
In today's interview, Dr. Keagen Hadley describes how he built a flexible and lucrative nonclinical career in regulatory medical writing.
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What Regulatory Writing Involves
Rather than focusing on marketing copy or patient education, regulatory medical writing centers on the core documents that move drugs and devices through development: study protocols, investigator brochures, clinical study reports, and related submissions.
Keagen explains how writers translate study designs, data, and safety information into clear, consistent documents that meet strict regulatory and ICH guidelines, and how they collaborate with clinicians, statisticians, and project managers across a trial.
He also highlights the appeal of the work: structured, detail-oriented tasks, predictable timelines, fully remote setups, and the chance to influence new therapies at a systems level rather than through individual patient visits.
Starting a Writing Business
After building experience inside a CRO (contract research organization), Dr. Hadley transitioned into consulting so he could choose his projects and control his schedule.
He emphasizes getting comfortable with the “meat and potatoes” of regulatory writing, protocols, investigator brochures, and clinical study reports, and pairing that with a solid grasp of the drug-development pathway and applicable regulations.
Honing Your Skills
To move in this direction, he points to sharpening writing and Microsoft Word skills, and learning GxP basics (“Good X Practices,” an acronym representing a set of quality guidelines and regulations in the pharmaceutical industry, where “x” is a placeholder for specific fields).
He recommends learning to network on LinkedIn, and joining organizations like AMWA (American Medical Writers Association) and RAPS (Regulatory Affairs Professionals Society), And he offers his free resource, the Clinician’s Guide to Regulatory Writing Substack, to build knowledge, credibility, and client relationships.
Summary
This episode lays out a realistic path from clinical or research work into regulatory medical writing. And he explains how strong communication skills and comfort with structure can translate into a part-time remote career and, eventually, lucrative independent consulting.
NOTE: Look below for a transcript of today's episode.
Links for Today's Episode:
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- Dr. Keagan Hadley's Clinician’s Guide to Regulatory Writing (Substack)
- Six-Month Roadmap to Becoming a Regulatory Medical Writer
- Dr. Keagan Hadley's LinkedIn
- American Medical Writers Association (AMWA)
- Regulatory Affairs Professionals Society (RAPS)
- 19 Nonclinical Career Summit Lectures
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Transcription PNC Podcast Episode 444
How To Start Your Lucrative New Regulatory Writing Business
- Interview with Dr. Keagen Hadley
John: I invited today's guest because he is a regulatory medical writer and a strong proponent of this profession for nurses, physicians, and other healthcare professionals. So just right up our alley, I have physicians that want to learn about this. And he happens to be trained as an occupational therapist, but what he has done certainly can be duplicated by interested physicians. Dr. Keagen Hadley, welcome to the PNC podcast.
Dr. Keagen Hadley: Hey, John, thanks for having me.
John: Well, why don't you just tell us a little bit about yourself, your story? I've read it on LinkedIn and so forth, and maybe in your sub stack, but why don't you give us the short version of how you got to where you are now?
Dr. Keagen Hadley: Yeah, of course. In undergrad, I had a hard time picking what I wanted to do. I ended up just going pre-med because you can kind of go, as your audience knows, about 47 different ways.
But what I became acutely aware of is after undergrad, waiting between undergrad and grad school to save up a little money, I wasn't really qualified to do a whole heck of a lot with a pre-med degree. Nurses are pretty in a good spot there, and maybe a couple other healthcare professionals, but not just with a generic pre-med because I had already done the CNA stuff throughout undergrad, and I wanted to kind of do something else. So I was lucky enough to get hired at a small contract research organization in Midwest as an in-house clinical research associate, or CRA.
There's a ton of acronyms here. And I went into that interview thinking that there was going to be a lab on the premises. There wasn't, because I had done undergrad research, so the fact I even got that job is still kind of humorous to me.
But what they essentially do is handle the operations for larger pharmaceutical companies, think like Moderna, Pfizer, and aspects of the trial that they maybe don't have the bandwidth to handle, you outsource that to a contract research organization. So I was helping manage like sites like at UCLA or whatever, make sure they were ready to go and have all their paperwork in, and those kinds of things. And while I was doing that job for about a year, year and a half, one of my favorite tasks I was delegated was helping work on the clinical or regulatory documents for the trial, because we were such a small contract research organization out in North Dakota.
We didn't have a medical writing department, but I absolutely loved it. I've always, just a little context on me, I've always loved the idea of writing, but I never really thought I'd be able to make money doing it unless you write Harry Potter 83, which I wasn't planning on doing. So around that time when I was really enjoying that work, I was, our CEO at the time mentioned that they were thinking about bringing on a consultant regulatory medical writer, and that was the first I'd ever heard this was even a profession.
So being in the Midwest, middle of nowhere, we don't have biotechs and pharmaceutical companies, but where I got on LinkedIn, which is where I basically made most of my meaningful connections in the industry and just kind of went down the rabbit hole of finding people who were doing that job and seeing who would be agreeable to being a mentor-like person. And I eventually found my mentor who had been in the industry much longer than I had even been alive at that point. So she was a wealth of information for me, kind of got me started on, this is a framework for how you could pursue getting into the industry.
And I felt I started to follow that. And right around that time is when I was getting into graduate school, because I decided kind of behind the scenes, I wanted to get my terminal degree. So I started school and I wanted to do, I wanted to get into this industry at the same time to help pay for school.
That was kind of my way to do it. I didn't anticipate I'd love it as much as I would find out I would, but so I started, I did those simultaneously. So I was building out this career plus going to grad school at the same time.
I was working nights or weekends, but I went through school. And by the time I actually graduated the three-year program, regulatory medical had taken off so it didn't make a lot of financial sense to go back and enter the workforce as a entry-level therapist. So years down the road here, and I'm still doing it. I've never actually held a normal occupational therapy job up until this point.
John: Well, you've got the PhD and you did all that work and it probably helped a lot, I think, at some degree in terms of writing and just being in that whole milieu of clinical, I suppose, although you already were in it.
Dr. Keagen Hadley: Yeah, yeah, for sure. It helps you jump a couple steps when you're kind of dealing with writing particular sections of documents with a clinical development professional, which is usually like a physician in the specialty area in question. So you're able to understand what they're trying to do much quicker than if you didn't have that background in the medical field.
John: Now, usually if I'm talking about a physician or to a physician about pursuing a writing job, it starts with the, well, there are how many different types of medical writing jobs, but you were basically just, boom, zoomed in on it as soon as you learned about it. So what was it that you liked about it that made you think, wow, this is awesome?
Dr. Keagen Hadley: Yeah, before I had found this, I was trying to do like a Venn diagram of what I'm interested in and what I like doing and what I sort of found is I want to help people, but I'm also extremely interested in innovation. Those were, I really liked those two aspects and this just happened to fall right in the middle because you are sending the documents that have the potential to save a lot of lives. So it's kind of the perfect balance that I really, really enjoy.
John: Can you define for us exactly what do you mean by regulatory medical writing? Because I can think of different things, but I don't know, writing package inserts for a drug or what would it be?
Dr. Keagen Hadley: Essentially a regulatory medical writer is writing the documents that to a regulatory agency like the FDA to get a product approved, whether that be a drug, a biologic or a device. So there's a ton of different documents that go into that. They all lead up to the package insert, but that's way down the line and I'm over 10 years in and I've barely touched some of that stuff. There's a lot of different things you can work on. All that to say is anything that you need to have written to get a product approved.
John: What would some of those, I know it's some kind of vernacular that most of us are not familiar with, but what would be the name of some of those documents?
Dr. Keagen Hadley: Yeah. So I call them the meat and potato documents. For the first five years, I worked on primarily these three documents. There would be a protocol, which is essentially the plan, the study design of how you're going to run the trial. You have an investigator brochure or an IV, which is if you as a physician were going to provide this investigational product to your patients, it's everything you'd want to know about that product before you start giving it to your patients. It's got like the non-clinical information, any safety or efficacy data in the background on the product as well.
And then the clinical study report or a CSR is essentially the first part of a CSR is just the protocol in past tense. And then there's sections at the end that go over actually, okay, what was the data that we accumulated in that trial? So those are the three most common documents.
John: Now, you did mention this issue of a CRO that you worked for. So now sometimes this writing, well, correct me unless I'm wrong. correct me if I am wrong. I don't know, there's a bulk of that done by a CRO because I know that the pharmaceutical companies and the others, they use these, they farm this out, but then again, some have their own. So is there a mix of either or how does that work?
Dr. Keagen Hadley: Yeah, it's a great question. Every company does it slightly different. So I was with Moderna in around 2020. They did a lot of stuff in-house, but actually I started, I did all of it as a consultant. So they did have internal, but I was actually a consultant. So I got a peek behind the door there.
I've primarily worked with small biotech companies ever since my, I was been in the industry about four years. I've kind of focused on smaller biotech companies, but each company does it slightly different. And that's no matter really what you're talking about, each company has a slight tweak on how they're doing things. As far as sourcing templates, you name it, it's all slightly different.
John: One of the things that comes up a lot when I'm talking to physicians or wondering about jobs in this field, not so much the writing only, but the pharmacy, let's say pharmaceutical companies. So then the question is they're trying to figure out like how does a pharma company, how is it built? how is it put together?
And so if you're working directly for a pharma company, then would you be writing for the clinical research part of that company when you're doing this kind of writing? I know it's kind of carved out, but.
Dr. Keagen Hadley: Well, both, depending on there's two whole sides of when people think of medical writing, the one thing they have to realize is I've run, I've written tons and tons of documents and you will never find any of my documents on the internet, which is kind of the opposite of what people think of when they think of medical writing. You're thinking of maybe a journal, all that is done after typically a drug is approved. So that's a whole, that's medical affairs.
I haven't really dealt with that realm, but a lot of the time, especially if you're developing a product like a drug biologic, the documents are all the same, whether you're working at a CRO, a pharma company, a biotech company, they're all the same documents, but it's just how you're sourcing them, who's actually writing the documents. It's slightly different in what your model is as far as a business, if that makes sense.
John: Yeah. Yes. All right. Well, what type of physician or what type of person, I guess I would say is most suited for the kind of work that you're doing, or you can turn it around and say, what do you like about it? Yeah. Maybe you want to lie with somebody else.
Dr. Keagen Hadley: Yeah. One thing I always wanted was something that was very flexible. I love to travel. I love working out and those kinds of things for mental health and a wide variety of reasons. I really like staying active and this job allows me to build my day around my life rather than trying to fit things in where I can, which I think based on my classmates and other colleagues and clinicians that I spoke to is a big plus. So for example, today I didn't have any meetings until noon, so I was able to go work out, get a couple of things done for our house.
I'm going to surprise my wife with a few things and I got a workout done all before my meeting started. That being said, obviously you do have tasks behind the scene that you can't just let sit until you have meetings. So you kind of just fit that in where you can, but it's supremely flexible.
John: What I've learned in the past, when I talked to other medical writers is the, it's not the downside, but it's just a matter of you need to be disciplined. You mean you can't put something off for a week or two weeks when it's due in 14 days?
Dr. Keagen Hadley: Yeah. That's another thing is I'm extremely proactive. So if you're on the side of things where you like to procrastinate, it might be a bit more challenging for you because everything's built out on our timeline.
The protocol will be written in a couple of months or months ahead of time. Typically that's not always the case depending on who you're working with. But it's not a quick document that you're just going to crank out in a week.
You have to do a lot of planning beforehand. So you kind of know what it's going to look like. And if you're the type of person that puts stuff till the end, it might be a bit more challenging.
I like to do things as far in advance as I can, just to reduce any kind of stress. So there's always going to be a little, but for what I can control, it's good if you're the type of person that likes to get stuff done way ahead of time.
John: What other aspects are positive from your perspective?
Dr. Keagen Hadley: Another calculation I was doing in grad school is, I told you I wanted to help people, but you're kind of limited. No matter how efficient you are in your day job as a clinician, your max is you're going to see X number of patients that day, which you can kind of extrapolate out. And okay, this is theoretically, if I work every day, a full day, this is how many patients I'm going to see.
And what I found was, if I get a product approved that's truly needed, and we can talk about that later on how you pick your opportunities, because there's ones that are just kind of money related and not really helping patients related, but you can really look at a patient population and be like, I have the potential to help this many people based on the epidemiological background of that particular condition. So I found that very interesting, and I can be working on multiple of those at a time and hopefully get a number of them approved throughout my career and really make a big difference.
John: I think that's going to really resonate with the physicians that are listening, because this comes up a lot. It's like, I'm leaving my profession, I'm leaving this commitment to patient care. Okay, fine. That's a good thing to do, to be taking care of patients. But in almost every non-clinical job that I know of, you end up helping more people, because you're doing things like you're doing that has an impact on not even just dozens, but hundreds or thousands of patients. And it could be anything, even working with an attorney, you're helping patients who need care, and they didn't get their care, and so you're going to help them.
Dr. Keagen Hadley: Exactly, exactly. What I've found is it's vastly, I can help vastly more people to your point that I could in my current career rather than what I could have done if I would have followed the more typical route.
John: Now, can I extrapolate from what you said about the flexibility that you can do this? You don't have to be at home to do this. I'm assuming if you're in touch and you have a computer, you could be almost anywhere.
Dr. Keagen Hadley: Yeah, I actually have a fun story about that. My sister got married in Jamaica back in 2021, and I didn't have, I couldn't take time off. And I was, my dear wife was out on the beach and I was in our in our room overlooking the beach working in England, both in order to be there for my sister as well as kind of relax.
Yes, if you have Wi-Fi, and that's what the asterisk now, some companies are doing some tax related policies. So you can only be outside of your home office for I think it's like two weeks. There's some companies that do that. Just be aware of that. But theoretically, yes, as long as you have likely a VPN, internet access in your computer, you can work.
John: Okay. What other things would attract a physician or any clinician to doing this that you can think of if there is any?
Dr. Keagen Hadley: Well, the pay is much better than I thought it was. And I like being very transparent. So I don't know what you would want to know about that. But it's not, especially for allied health professionals. It's extremely attractive. And I think for physicians, it would be much better than what they would maybe anticipate for a writing job. I will say that.
John: Yeah. Well, tell us about that. That's definitely going to be important. And so I think I saw you quoted or maybe anyway, there was like an average but that depended on what you were doing. Tell us about those averages for medical writing and particularly regulatory and what you've seen other people achieve.
Dr. Keagen Hadley: Yeah, yeah, yeah, for sure. The average, I'm going to do this off of memory here. So the average salary based on the AMWA report that they put out annually is for salaried people is 166 grand, but that is for permanent employees. And we can get into the distinction there. You get paid less essentially per hour, but you have more stability. So that's the average there just general.
But then if you get into regulatory, it's roughly around 200,000 is the average salary. But then if you get into consulting, it's 230 to 270 280. So it could really is the sky's the limit as far as as far as how efficient you are too. And we can talk about that. But those are essentially the raw numbers in my experience has been very indicative of that.
John: Now what do you mean when you're talking about writing as a consulting or consultant that your own business?
Dr. Keagen Hadley: Yeah. Essentially up until more recently, I did strictly consulting because then you can take on so I can work for Moderna, I can work for Pfizer. And I can work for company x all at the same time for you might have 20 hours a week, 20 hour a week contract for each of them. And you're getting paid a much higher wage per hour. So for example, my hourly rate right now is $175 an hour. So if you could, you look at that, it's a decently high price.
But you what you do have to be aware of is it's a 20 hour week contract. In this example, some weeks, there'll be six hours of work and some weeks, there'll be 38 hours of work for one contract. So you do have to plan appropriately. And actually, that fact is how I broke into the industry. And I can explain why.
John: Yeah, we'll get into that for sure. But I want to just comment on this. If you look at a family physician who's working a full time job, and let's say they're making $200,000 a year or something, it's probably higher than that now.
But the thing is, if you look at them, they're working 60 to 70 hours a week. So that's less than $175 an hour, I guarantee you. So I think people need to realize that when you're practicing medicine you get asked to do a lot of things that really are not on the books, because that's just the way it is.
When something like this, okay, fine, you might only get a job that you know, one week, you're doing 20 hours and next week, 30. But you're getting paid on an hourly basis better than what you were getting as a family doctor and getting burned out at the same time.
Dr. Keagen Hadley: And you can stack those, like I said, a really common contract number of hours per week is 20. So you could theoretically have three at the same time if they were, if the timelines were matching up appropriately, because no one really wants to work 60 hours a week. But you know, in a pinch, you probably could do that every so often. And I get physicians are actually a great example there, because you guys, depending on which specialty you are, I think that's maybe the norm is like 60, isn't it? You'd know better.
John: Right. That's very pretty much happens all the time. I have friends that go home every night and do two hours of charts like, really?
Dr. Keagen Hadley: Yeah, yeah, yeah.
John: EMR is supposed to save us, but did the exact opposite. And is it difficult? How hard is it to, if you're doing it as a consultant, to keep that thing full, like you've always got the next job, the next job, is it difficult?
Dr. Keagen Hadley: Yeah. As a consultant, you're kind of having to, you're doing the writing portion, but to your point, you're always planning. So it's a six month, 20 hour week contract, and they could extend you.
Theoretically, you do a good job, they'll likely extend you. But you always have to kind of do business development with yourself to be like, okay, well, this contract's getting about two months out, I need to connect with my five recruiter friends and let them know, hey, I'm looking for the next thing. So you always kind of have to be looking ahead too.
That's one positive, not the one, that's one of the positive things about working permanent or for a salary is you don't have to have that constant business development aspect, but you are all dependent on one company and the industry it's feast or famine. So when things are going great, they're great. But if your company gets a bad a data readout you could have a lot of layoffs. So that's another thing to consider.
John: That makes sense. Well, the next thing I'm going to ask you is about the process of going from not being a regulatory writer to being one, especially as a physician. But we might be, you have to go backwards.
But no, the reason I'm saying that is that you need to build these relationships, I guess is what I'm saying. It's not something that happens overnight. And you also need to develop the skills if you don't need to have the skills.
Why don't you take us through that process? Oh, yeah. And the question I have is now are you, I've seen your sub stack I haven't subscribed to the paid version of it at this point. But are you helping other clinicians do this and as a coach into the sub stack through other methods?
Dr. Keagen Hadley: Yeah, essentially what I'm doing, that's a fantastic question. So the clinician's guide to regulatory writing, which is my sub stack publication is essentially born from, I wasn't getting, I wouldn't use it, I won't term it as I was getting tired of answering the same questions again, because I enjoy talking to clinicians about this opportunity. But I was answering the same questions over and over.
And I was like I should, I write, I should probably just put this and then be able to send a link to someone. So then I started doing that. And it kind of expanded from there, I do have some extremely low price, like training materials, and I do offer some one to one coaching, but I, it's definitely not a for money thing.
It's just more of getting the word out there, because this industry truly changed my life. I didn't come from much. So I'm trying to get the word out there a little bit more, because I didn't even know it was a pathway. It's definitely not a for money thing.
John: Well, we'll get those links in a minute. So people know where to look for you. But tell me then at a high level, if I'm a physician, I've been working for 1520 years, I'm ready to do something else.
I don't necessarily have a million dollars in the bank. So I'm not going to just quit my job and start working on this. How would I, how would you recommend that someone transition to this after they've kind of determined that it's something they might be interested in?
Dr. Keagen Hadley: Yeah, that's a good question. And actually, physicians are really well suited to this because they're much more, much more involved in research anyways, it's harder when you get into more of the allied health or the nursing where we're not the primary or secondary author of some, some large article or publication. So it's much easier on you guys, because you already have a decent background in research.
But what you have to do is just learn about the drug development process. Overall, I think that that's crucial. And I have a six month roadmap, I'll show you the link to that goes through each of these steps in quite a bit more detail.
But we have to look through the drug development process and the regulations is a regulatory medical writer regulations are kind of a big deal. And there's you don't have to memorize them. But you do need to know where to look to get the information because the teams are working with at the either the pharmaceutical biotech or medical device companies will depend on you to know about those regulations, you're the subject matter expert of them.
So you have to know where to look and be able to answer the appropriate questions. So starting out with a good understanding, or at least knowing which regulation goes to which meat and potato document is very important. And then working on obviously writing, physicians do a lot of writing, but there's probably some slight tweaks there.
And that's something that maybe I don't want to speak for physicians, but the other healthcare clinicians that I speak to one of their main hesitancies about moving into regulatory medical writing is they worry about not being a good enough writer. And it's not, you're not writing a story, you're essentially writing in a very technical, clear way. So you just have to learn the few rules there, you do have to brush up on a few things, I'm not going to lie to you.
But it's not as intimidating as you would expect it to be, you have to become much more knowledgeable in Microsoft Word, everything you do as a regulatory medical writer, for the most part, as far as the writing aspect is housed in Microsoft Word. And you may think you know, Microsoft Word, but I'm in there every day, and I'm still learning new things all the time. So it's one of those, it's like not knowing where eval room three is and expecting to do a good eval in that room. And then all the key points that networking and outreach for not only mentors, recruiters, and just colleagues is really, really important. So those are kind of the four pillars.
John: Very good. I think I'm losing my voice. But I think we're good. We can keep going. So now tell us, yeah, the we get a hold of the information to look at the sub stack.
Dr. Keagen Hadley: Yeah, I can get you links.
John: We'll put those into the show notes of the episode, and make sure everyone can find what they need. Is there anything else that you produce or that we need to know about to kind of follow you? Can listeners maybe just connect with you on LinkedIn, and maybe send you an email or something like that?
Dr. Keagen Hadley: Yeah, I'm extremely active on LinkedIn and sub stack. I'm happy to hear from anyone who might be interested in learning more. I'll send you whatever information you want. I'm always open to writing about the questions someone has.
John: All right. Well, any last words of wisdom for those physicians who are thinking about doing something like this? You know, I hesitate to, I kind of put everyone in a like they're burned out, they got to try something else, which is not really the reason to go into regulatory writing or any other career. I think you would agree.
Dr. Keagen Hadley: Yeah, agreed. Yeah, you'd want to be running to something not away from something else, because you might run into the same type of thing.
John: There are a lot of physicians that love writing and they've always done it somehow and it may not be medical or so this would definitely be right up their alley. Plus, and it kind of puts that scientific medical background in with it.
Dr. Keagen Hadley: And I will say, just for your listeners as well, is this is one aspect of a really large industry, like, like you might get into the industry as a regulatory medical writer. But one of my favorite clinical development leads is a endocrinologist, and she started in regulatory medical writing, and now she's very high up in clinical development. So what I'm saying is, you break into the industry as a whole, it's there's a million different ways you can go once you break in. So that's my new center.
John: Now that's that that makes, again, perfect sense. And there's so many opportunities in pharma and biotech. It's just the sky's the limit, really. Yes. Okay, you mentioned the AMWA, I think, earlier, you want to tell us what that is?
Dr. Keagen Hadley: Yeah, the American Medical Writers Association, I'm on the education committee. Oh, cool. For them. They have a lot of very helpful courses. And then they have like a, I don't want to call it a newsletter. It's like a publication they put out quarterly. It's very, very helpful, just news and kind of the trends in the industry. That's very, very helpful. But I definitely advocate for people reading that as well.
John: Any other professional organizations or other resources that people might be able to benefit from this off the top of your head?
Dr. Keagen Hadley: Yes, I would say RAPS. It's the Regulatory Affairs Professionals Society, I believe so it stands for now that I have to spell it out. I believe that's what it is. But that's very helpful as well, if you want to get more information on the regulatory side of things, all those different guidance documents that might be useful as you're getting acclimated to that, to a whole new industry.
John: That sounds good. I don't think I've ever heard of that one. So that's something I'm going to have to look up too. All right. Well, I think those are all my questions. You've kind of filled this in pretty thoroughly in the last 25 minutes or so. This has been really good. This is the deepest dive I've ever gone into regulatory medical writing for physicians. This is, I learned about other forms of medical writing CME, things like that.
But this is very interesting. And it seems to be probably when you get really good at it, maybe highest paid type of writing that in this general category of medical writing, from what I could tell.
Dr. Keagen Hadley: Yeah, yeah. There's also, I don't know how far you want to get down this. Let's grab ahold, but regulatory medical writing has led me to ghostwriting too for a lot of the small biotech companies I work for, I work directly with the C-suite. And if they're trusting me to write the documents that are kind of the culmination of hundreds of millions of documents, the FDA, for example, doesn't evaluate your trial that you're running. They evaluate the documents you're submitting about the trial.
They obviously have to trust you quite a bit. So if they have to write a pitch deck, a business plan, those kinds of things, I've also done a lot of ghostwriting that's depending on where you're at, it can be quite lucrative.
John: Now, is that as a consultant at that point, if you're working with multiple?
Dr. Keagen Hadley: It's still, yeah, yeah, yeah. So you can have multiple, like I said, in that scenario where you have the three different ones, this would. I would probably drop one of the regulatory ones and continue to have a as needed or a document specific ghostwriting. That's also another opportunity.
John: Another new thing I've never heard of before. So that is awesome. This is very interesting. The deeper you go, the more you discover.
Dr. Keagen Hadley: There's always another door.
John: All right. Well, this has been great. I think we're pretty much out of time, but I will get all those links from you and we'll put those in the notes. And thanks for being here today. This has been very eye opening.
Dr. Keagen Hadley: Oh, likewise. Thank you, John. I appreciate the opportunity.
John: All right. With that, I'll say goodbye.
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Transcription PNC Podcast Episode 444
How To Start Your Lucrative New Regulatory Writing Business
- Interview with Dr. Keagen Hadley
John: I invited today's guest because he is a regulatory medical writer and a strong proponent of this profession for nurses, physicians, and other healthcare professionals. So just right up our alley, I have physicians that want to learn about this. And he happens to be trained as an occupational therapist, but what he has done certainly can be duplicated by interested physicians. Dr. Keagen Hadley, welcome to the PNC podcast.
Dr. Keagen Hadley: Hey, John, thanks for having me.
John: Well, why don't you just tell us a little bit about yourself, your story? I've read it on LinkedIn and so forth, and maybe in your sub stack, but why don't you give us the short version of how you got to where you are now?
Dr. Keagen Hadley: Yeah, of course. In undergrad, I had a hard time picking what I wanted to do. I ended up just going pre-med because you can kind of go, as your audience knows, about 47 different ways.
But what I became acutely aware of is after undergrad, waiting between undergrad and grad school to save up a little money, I wasn't really qualified to do a whole heck of a lot with a pre-med degree. Nurses are pretty in a good spot there, and maybe a couple other healthcare professionals, but not just with a generic pre-med because I had already done the CNA stuff throughout undergrad, and I wanted to kind of do something else. So I was lucky enough to get hired at a small contract research organization in Midwest as an in-house clinical research associate, or CRA.
There's a ton of acronyms here. And I went into that interview thinking that there was going to be a lab on the premises. There wasn't, because I had done undergrad research, so the fact I even got that job is still kind of humorous to me.
But what they essentially do is handle the operations for larger pharmaceutical companies, think like Moderna, Pfizer, and aspects of the trial that they maybe don't have the bandwidth to handle, you outsource that to a contract research organization. So I was helping manage like sites like at UCLA or whatever, make sure they were ready to go and have all their paperwork in, and those kinds of things. And while I was doing that job for about a year, year and a half, one of my favorite tasks I was delegated was helping work on the clinical or regulatory documents for the trial, because we were such a small contract research organization out in North Dakota.
We didn't have a medical writing department, but I absolutely loved it. I've always, just a little context on me, I've always loved the idea of writing, but I never really thought I'd be able to make money doing it unless you write Harry Potter 83, which I wasn't planning on doing. So around that time when I was really enjoying that work, I was, our CEO at the time mentioned that they were thinking about bringing on a consultant regulatory medical writer, and that was the first I'd ever heard this was even a profession.
So being in the Midwest, middle of nowhere, we don't have biotechs and pharmaceutical companies, but where I got on LinkedIn, which is where I basically made most of my meaningful connections in the industry and just kind of went down the rabbit hole of finding people who were doing that job and seeing who would be agreeable to being a mentor-like person. And I eventually found my mentor who had been in the industry much longer than I had even been alive at that point. So she was a wealth of information for me, kind of got me started on, this is a framework for how you could pursue getting into the industry.
And I felt I started to follow that. And right around that time is when I was getting into graduate school, because I decided kind of behind the scenes, I wanted to get my terminal degree. So I started school and I wanted to do, I wanted to get into this industry at the same time to help pay for school.
That was kind of my way to do it. I didn't anticipate I'd love it as much as I would find out I would, but so I started, I did those simultaneously. So I was building out this career plus going to grad school at the same time.
I was working nights or weekends, but I went through school. And by the time I actually graduated the three-year program, regulatory medical had taken off so it didn't make a lot of financial sense to go back and enter the workforce as a entry-level therapist. So years down the road here, and I'm still doing it. I've never actually held a normal occupational therapy job up until this point.
John: Well, you've got the PhD and you did all that work and it probably helped a lot, I think, at some degree in terms of writing and just being in that whole milieu of clinical, I suppose, although you already were in it.
Dr. Keagen Hadley: Yeah, yeah, for sure. It helps you jump a couple steps when you're kind of dealing with writing particular sections of documents with a clinical development professional, which is usually like a physician in the specialty area in question. So you're able to understand what they're trying to do much quicker than if you didn't have that background in the medical field.
John: Now, usually if I'm talking about a physician or to a physician about pursuing a writing job, it starts with the, well, there are how many different types of medical writing jobs, but you were basically just, boom, zoomed in on it as soon as you learned about it. So what was it that you liked about it that made you think, wow, this is awesome?
Dr. Keagen Hadley: Yeah, before I had found this, I was trying to do like a Venn diagram of what I'm interested in and what I like doing and what I sort of found is I want to help people, but I'm also extremely interested in innovation. Those were, I really liked those two aspects and this just happened to fall right in the middle because you are sending the documents that have the potential to save a lot of lives. So it's kind of the perfect balance that I really, really enjoy.
John: Can you define for us exactly what do you mean by regulatory medical writing? Because I can think of different things, but I don't know, writing package inserts for a drug or what would it be?
Dr. Keagen Hadley: Essentially a regulatory medical writer is writing the documents that to a regulatory agency like the FDA to get a product approved, whether that be a drug, a biologic or a device. So there's a ton of different documents that go into that. They all lead up to the package insert, but that's way down the line and I'm over 10 years in and I've barely touched some of that stuff. There's a lot of different things you can work on. All that to say is anything that you need to have written to get a product approved.
John: What would some of those, I know it's some kind of vernacular that most of us are not familiar with, but what would be the name of some of those documents?
Dr. Keagen Hadley: Yeah. So I call them the meat and potato documents. For the first five years, I worked on primarily these three documents. There would be a protocol, which is essentially the plan, the study design of how you're going to run the trial. You have an investigator brochure or an IV, which is if you as a physician were going to provide this investigational product to your patients, it's everything you'd want to know about that product before you start giving it to your patients. It's got like the non-clinical information, any safety or efficacy data in the background on the product as well.
And then the clinical study report or a CSR is essentially the first part of a CSR is just the protocol in past tense. And then there's sections at the end that go over actually, okay, what was the data that we accumulated in that trial? So those are the three most common documents.
John: Now, you did mention this issue of a CRO that you worked for. So now sometimes this writing, well, correct me unless I'm wrong. correct me if I am wrong. I don't know, there's a bulk of that done by a CRO because I know that the pharmaceutical companies and the others, they use these, they farm this out, but then again, some have their own. So is there a mix of either or how does that work?
Dr. Keagen Hadley: Yeah, it's a great question. Every company does it slightly different. So I was with Moderna in around 2020. They did a lot of stuff in-house, but actually I started, I did all of it as a consultant. So they did have internal, but I was actually a consultant. So I got a peek behind the door there.
I've primarily worked with small biotech companies ever since my, I was been in the industry about four years. I've kind of focused on smaller biotech companies, but each company does it slightly different. And that's no matter really what you're talking about, each company has a slight tweak on how they're doing things. As far as sourcing templates, you name it, it's all slightly different.
John: One of the things that comes up a lot when I'm talking to physicians or wondering about jobs in this field, not so much the writing only, but the pharmacy, let's say pharmaceutical companies. So then the question is they're trying to figure out like how does a pharma company, how is it built? how is it put together?
And so if you're working directly for a pharma company, then would you be writing for the clinical research part of that company when you're doing this kind of writing? I know it's kind of carved out, but.
Dr. Keagen Hadley: Well, both, depending on there's two whole sides of when people think of medical writing, the one thing they have to realize is I've run, I've written tons and tons of documents and you will never find any of my documents on the internet, which is kind of the opposite of what people think of when they think of medical writing. You're thinking of maybe a journal, all that is done after typically a drug is approved. So that's a whole, that's medical affairs.
I haven't really dealt with that realm, but a lot of the time, especially if you're developing a product like a drug biologic, the documents are all the same, whether you're working at a CRO, a pharma company, a biotech company, they're all the same documents, but it's just how you're sourcing them, who's actually writing the documents. It's slightly different in what your model is as far as a business, if that makes sense.
John: Yeah. Yes. All right. Well, what type of physician or what type of person, I guess I would say is most suited for the kind of work that you're doing, or you can turn it around and say, what do you like about it? Yeah. Maybe you want to lie with somebody else.
Dr. Keagen Hadley: Yeah. One thing I always wanted was something that was very flexible. I love to travel. I love working out and those kinds of things for mental health and a wide variety of reasons. I really like staying active and this job allows me to build my day around my life rather than trying to fit things in where I can, which I think based on my classmates and other colleagues and clinicians that I spoke to is a big plus. So for example, today I didn't have any meetings until noon, so I was able to go work out, get a couple of things done for our house.
I'm going to surprise my wife with a few things and I got a workout done all before my meeting started. That being said, obviously you do have tasks behind the scene that you can't just let sit until you have meetings. So you kind of just fit that in where you can, but it's supremely flexible.
John: What I've learned in the past, when I talked to other medical writers is the, it's not the downside, but it's just a matter of you need to be disciplined. You mean you can't put something off for a week or two weeks when it's due in 14 days?
Dr. Keagen Hadley: Yeah. That's another thing is I'm extremely proactive. So if you're on the side of things where you like to procrastinate, it might be a bit more challenging for you because everything's built out on our timeline.
The protocol will be written in a couple of months or months ahead of time. Typically that's not always the case depending on who you're working with. But it's not a quick document that you're just going to crank out in a week.
You have to do a lot of planning beforehand. So you kind of know what it's going to look like. And if you're the type of person that puts stuff till the end, it might be a bit more challenging.
I like to do things as far in advance as I can, just to reduce any kind of stress. So there's always going to be a little, but for what I can control, it's good if you're the type of person that likes to get stuff done way ahead of time.
John: What other aspects are positive from your perspective?
Dr. Keagen Hadley: Another calculation I was doing in grad school is, I told you I wanted to help people, but you're kind of limited. No matter how efficient you are in your day job as a clinician, your max is you're going to see X number of patients that day, which you can kind of extrapolate out. And okay, this is theoretically, if I work every day, a full day, this is how many patients I'm going to see.
And what I found was, if I get a product approved that's truly needed, and we can talk about that later on how you pick your opportunities, because there's ones that are just kind of money related and not really helping patients related, but you can really look at a patient population and be like, I have the potential to help this many people based on the epidemiological background of that particular condition. So I found that very interesting, and I can be working on multiple of those at a time and hopefully get a number of them approved throughout my career and really make a big difference.
John: I think that's going to really resonate with the physicians that are listening, because this comes up a lot. It's like, I'm leaving my profession, I'm leaving this commitment to patient care. Okay, fine. That's a good thing to do, to be taking care of patients. But in almost every non-clinical job that I know of, you end up helping more people, because you're doing things like you're doing that has an impact on not even just dozens, but hundreds or thousands of patients. And it could be anything, even working with an attorney, you're helping patients who need care, and they didn't get their care, and so you're going to help them.
Dr. Keagen Hadley: Exactly, exactly. What I've found is it's vastly, I can help vastly more people to your point that I could in my current career rather than what I could have done if I would have followed the more typical route.
John: Now, can I extrapolate from what you said about the flexibility that you can do this? You don't have to be at home to do this. I'm assuming if you're in touch and you have a computer, you could be almost anywhere.
Dr. Keagen Hadley: Yeah, I actually have a fun story about that. My sister got married in Jamaica back in 2021, and I didn't have, I couldn't take time off. And I was, my dear wife was out on the beach and I was in our in our room overlooking the beach working in England, both in order to be there for my sister as well as kind of relax.
Yes, if you have Wi-Fi, and that's what the asterisk now, some companies are doing some tax related policies. So you can only be outside of your home office for I think it's like two weeks. There's some companies that do that. Just be aware of that. But theoretically, yes, as long as you have likely a VPN, internet access in your computer, you can work.
John: Okay. What other things would attract a physician or any clinician to doing this that you can think of if there is any?
Dr. Keagen Hadley: Well, the pay is much better than I thought it was. And I like being very transparent. So I don't know what you would want to know about that. But it's not, especially for allied health professionals. It's extremely attractive. And I think for physicians, it would be much better than what they would maybe anticipate for a writing job. I will say that.
John: Yeah. Well, tell us about that. That's definitely going to be important. And so I think I saw you quoted or maybe anyway, there was like an average but that depended on what you were doing. Tell us about those averages for medical writing and particularly regulatory and what you've seen other people achieve.
Dr. Keagen Hadley: Yeah, yeah, yeah, for sure. The average, I'm going to do this off of memory here. So the average salary based on the AMWA report that they put out annually is for salaried people is 166 grand, but that is for permanent employees. And we can get into the distinction there. You get paid less essentially per hour, but you have more stability. So that's the average there just general.
But then if you get into regulatory, it's roughly around 200,000 is the average salary. But then if you get into consulting, it's 230 to 270 280. So it could really is the sky's the limit as far as as far as how efficient you are too. And we can talk about that. But those are essentially the raw numbers in my experience has been very indicative of that.
John: Now what do you mean when you're talking about writing as a consulting or consultant that your own business?
Dr. Keagen Hadley: Yeah. Essentially up until more recently, I did strictly consulting because then you can take on so I can work for Moderna, I can work for Pfizer. And I can work for company x all at the same time for you might have 20 hours a week, 20 hour a week contract for each of them. And you're getting paid a much higher wage per hour. So for example, my hourly rate right now is $175 an hour. So if you could, you look at that, it's a decently high price.
But you what you do have to be aware of is it's a 20 hour week contract. In this example, some weeks, there'll be six hours of work and some weeks, there'll be 38 hours of work for one contract. So you do have to plan appropriately. And actually, that fact is how I broke into the industry. And I can explain why.
John: Yeah, we'll get into that for sure. But I want to just comment on this. If you look at a family physician who's working a full time job, and let's say they're making $200,000 a year or something, it's probably higher than that now.
But the thing is, if you look at them, they're working 60 to 70 hours a week. So that's less than $175 an hour, I guarantee you. So I think people need to realize that when you're practicing medicine you get asked to do a lot of things that really are not on the books, because that's just the way it is.
When something like this, okay, fine, you might only get a job that you know, one week, you're doing 20 hours and next week, 30. But you're getting paid on an hourly basis better than what you were getting as a family doctor and getting burned out at the same time.
Dr. Keagen Hadley: And you can stack those, like I said, a really common contract number of hours per week is 20. So you could theoretically have three at the same time if they were, if the timelines were matching up appropriately, because no one really wants to work 60 hours a week. But you know, in a pinch, you probably could do that every so often. And I get physicians are actually a great example there, because you guys, depending on which specialty you are, I think that's maybe the norm is like 60, isn't it? You'd know better.
John: Right. That's very pretty much happens all the time. I have friends that go home every night and do two hours of charts like, really?
Dr. Keagen Hadley: Yeah, yeah, yeah.
John: EMR is supposed to save us, but did the exact opposite. And is it difficult? How hard is it to, if you're doing it as a consultant, to keep that thing full, like you've always got the next job, the next job, is it difficult?
Dr. Keagen Hadley: Yeah. As a consultant, you're kind of having to, you're doing the writing portion, but to your point, you're always planning. So it's a six month, 20 hour week contract, and they could extend you.
Theoretically, you do a good job, they'll likely extend you. But you always have to kind of do business development with yourself to be like, okay, well, this contract's getting about two months out, I need to connect with my five recruiter friends and let them know, hey, I'm looking for the next thing. So you always kind of have to be looking ahead too.
That's one positive, not the one, that's one of the positive things about working permanent or for a salary is you don't have to have that constant business development aspect, but you are all dependent on one company and the industry it's feast or famine. So when things are going great, they're great. But if your company gets a bad a data readout you could have a lot of layoffs. So that's another thing to consider.
John: That makes sense. Well, the next thing I'm going to ask you is about the process of going from not being a regulatory writer to being one, especially as a physician. But we might be, you have to go backwards.
But no, the reason I'm saying that is that you need to build these relationships, I guess is what I'm saying. It's not something that happens overnight. And you also need to develop the skills if you don't need to have the skills.
Why don't you take us through that process? Oh, yeah. And the question I have is now are you, I've seen your sub stack I haven't subscribed to the paid version of it at this point. But are you helping other clinicians do this and as a coach into the sub stack through other methods?
Dr. Keagen Hadley: Yeah, essentially what I'm doing, that's a fantastic question. So the clinician's guide to regulatory writing, which is my sub stack publication is essentially born from, I wasn't getting, I wouldn't use it, I won't term it as I was getting tired of answering the same questions again, because I enjoy talking to clinicians about this opportunity. But I was answering the same questions over and over.
And I was like I should, I write, I should probably just put this and then be able to send a link to someone. So then I started doing that. And it kind of expanded from there, I do have some extremely low price, like training materials, and I do offer some one to one coaching, but I, it's definitely not a for money thing.
It's just more of getting the word out there, because this industry truly changed my life. I didn't come from much. So I'm trying to get the word out there a little bit more, because I didn't even know it was a pathway. It's definitely not a for money thing.
John: Well, we'll get those links in a minute. So people know where to look for you. But tell me then at a high level, if I'm a physician, I've been working for 1520 years, I'm ready to do something else.
I don't necessarily have a million dollars in the bank. So I'm not going to just quit my job and start working on this. How would I, how would you recommend that someone transition to this after they've kind of determined that it's something they might be interested in?
Dr. Keagen Hadley: Yeah, that's a good question. And actually, physicians are really well suited to this because they're much more, much more involved in research anyways, it's harder when you get into more of the allied health or the nursing where we're not the primary or secondary author of some, some large article or publication. So it's much easier on you guys, because you already have a decent background in research.
But what you have to do is just learn about the drug development process. Overall, I think that that's crucial. And I have a six month roadmap, I'll show you the link to that goes through each of these steps in quite a bit more detail.
But we have to look through the drug development process and the regulations is a regulatory medical writer regulations are kind of a big deal. And there's you don't have to memorize them. But you do need to know where to look to get the information because the teams are working with at the either the pharmaceutical biotech or medical device companies will depend on you to know about those regulations, you're the subject matter expert of them.
So you have to know where to look and be able to answer the appropriate questions. So starting out with a good understanding, or at least knowing which regulation goes to which meat and potato document is very important. And then working on obviously writing, physicians do a lot of writing, but there's probably some slight tweaks there.
And that's something that maybe I don't want to speak for physicians, but the other healthcare clinicians that I speak to one of their main hesitancies about moving into regulatory medical writing is they worry about not being a good enough writer. And it's not, you're not writing a story, you're essentially writing in a very technical, clear way. So you just have to learn the few rules there, you do have to brush up on a few things, I'm not going to lie to you.
But it's not as intimidating as you would expect it to be, you have to become much more knowledgeable in Microsoft Word, everything you do as a regulatory medical writer, for the most part, as far as the writing aspect is housed in Microsoft Word. And you may think you know, Microsoft Word, but I'm in there every day, and I'm still learning new things all the time. So it's one of those, it's like not knowing where eval room three is and expecting to do a good eval in that room. And then all the key points that networking and outreach for not only mentors, recruiters, and just colleagues is really, really important. So those are kind of the four pillars.
John: Very good. I think I'm losing my voice. But I think we're good. We can keep going. So now tell us, yeah, the we get a hold of the information to look at the sub stack.
Dr. Keagen Hadley: Yeah, I can get you links.
John: We'll put those into the show notes of the episode, and make sure everyone can find what they need. Is there anything else that you produce or that we need to know about to kind of follow you? Can listeners maybe just connect with you on LinkedIn, and maybe send you an email or something like that?
Dr. Keagen Hadley: Yeah, I'm extremely active on LinkedIn and sub stack. I'm happy to hear from anyone who might be interested in learning more. I'll send you whatever information you want. I'm always open to writing about the questions someone has.
John: All right. Well, any last words of wisdom for those physicians who are thinking about doing something like this? You know, I hesitate to, I kind of put everyone in a like they're burned out, they got to try something else, which is not really the reason to go into regulatory writing or any other career. I think you would agree.
Dr. Keagen Hadley: Yeah, agreed. Yeah, you'd want to be running to something not away from something else, because you might run into the same type of thing.
John: There are a lot of physicians that love writing and they've always done it somehow and it may not be medical or so this would definitely be right up their alley. Plus, and it kind of puts that scientific medical background in with it.
Dr. Keagen Hadley: And I will say, just for your listeners as well, is this is one aspect of a really large industry, like, like you might get into the industry as a regulatory medical writer. But one of my favorite clinical development leads is a endocrinologist, and she started in regulatory medical writing, and now she's very high up in clinical development. So what I'm saying is, you break into the industry as a whole, it's there's a million different ways you can go once you break in. So that's my new center.
John: Now that's that that makes, again, perfect sense. And there's so many opportunities in pharma and biotech. It's just the sky's the limit, really. Yes. Okay, you mentioned the AMWA, I think, earlier, you want to tell us what that is?
Dr. Keagen Hadley: Yeah, the American Medical Writers Association, I'm on the education committee. Oh, cool. For them. They have a lot of very helpful courses. And then they have like a, I don't want to call it a newsletter. It's like a publication they put out quarterly. It's very, very helpful, just news and kind of the trends in the industry. That's very, very helpful. But I definitely advocate for people reading that as well.
John: Any other professional organizations or other resources that people might be able to benefit from this off the top of your head?
Dr. Keagen Hadley: Yes, I would say RAPS. It's the Regulatory Affairs Professionals Society, I believe so it stands for now that I have to spell it out. I believe that's what it is. But that's very helpful as well, if you want to get more information on the regulatory side of things, all those different guidance documents that might be useful as you're getting acclimated to that, to a whole new industry.
John: That sounds good. I don't think I've ever heard of that one. So that's something I'm going to have to look up too. All right. Well, I think those are all my questions. You've kind of filled this in pretty thoroughly in the last 25 minutes or so. This has been really good. This is the deepest dive I've ever gone into regulatory medical writing for physicians. This is, I learned about other forms of medical writing CME, things like that.
But this is very interesting. And it seems to be probably when you get really good at it, maybe highest paid type of writing that in this general category of medical writing, from what I could tell.
Dr. Keagen Hadley: Yeah, yeah. There's also, I don't know how far you want to get down this. Let's grab ahold, but regulatory medical writing has led me to ghostwriting too for a lot of the small biotech companies I work for, I work directly with the C-suite. And if they're trusting me to write the documents that are kind of the culmination of hundreds of millions of documents, the FDA, for example, doesn't evaluate your trial that you're running. They evaluate the documents you're submitting about the trial.
They obviously have to trust you quite a bit. So if they have to write a pitch deck, a business plan, those kinds of things, I've also done a lot of ghostwriting that's depending on where you're at, it can be quite lucrative.
John: Now, is that as a consultant at that point, if you're working with multiple?
Dr. Keagen Hadley: It's still, yeah, yeah, yeah. So you can have multiple, like I said, in that scenario where you have the three different ones, this would. I would probably drop one of the regulatory ones and continue to have a as needed or a document specific ghostwriting. That's also another opportunity.
John: Another new thing I've never heard of before. So that is awesome. This is very interesting. The deeper you go, the more you discover.
Dr. Keagen Hadley: There's always another door.
John: All right. Well, this has been great. I think we're pretty much out of time, but I will get all those links from you and we'll put those in the notes. And thanks for being here today. This has been very eye opening.
Dr. Keagen Hadley: Oh, likewise. Thank you, John. I appreciate the opportunity.
John: All right. With that, I'll say goodbye.
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