medical affairs Archives - NonClinical Physicians https://nonclinicalphysicians.com/tag/medical-affairs/ Helping Hospital and Medical Group Executives Lead and Manage With Confidence Tue, 29 Aug 2023 12:48:02 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.2 https://nonclinicalphysicians.com/wp-content/uploads/2016/06/cropped-1-32x32.jpg medical affairs Archives - NonClinical Physicians https://nonclinicalphysicians.com/tag/medical-affairs/ 32 32 112612397 Develop These Essential Skills to Be a Visionary Medical Affairs Leader – 315 https://nonclinicalphysicians.com/medical-affairs-leader/ https://nonclinicalphysicians.com/medical-affairs-leader/#respond Tue, 29 Aug 2023 13:00:57 +0000 https://nonclinicalphysicians.com/?p=18798   Interview with Dr. Savi Chadha In today's episode, Dr. Sava Chadhi returns to the podcast to explain the steps he took to advance his career as a Medical Affairs Leader. Dr. Savi Chadha's pharmaceutical journey began as an MSL with Amplity Health in 2016 and later advanced to Supernus Pharmaceuticals in 2017, [...]

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Interview with Dr. Savi Chadha

In today's episode, Dr. Sava Chadhi returns to the podcast to explain the steps he took to advance his career as a Medical Affairs Leader.

Dr. Savi Chadha's pharmaceutical journey began as an MSL with Amplity Health in 2016 and later advanced to Supernus Pharmaceuticals in 2017, where he thrived. Once he was working as an MSL he completed board certification by the Medical Science Liaison Society. And his two nominations for MSL of the Year by the MSL Society reflect his exceptional contributions to the industry.


Our Sponsor

We're proud to have the University of Tennessee Physician Executive MBA Program, offered by the Haslam College of Business, as the sponsor of this podcast.

The UT PEMBA is the longest-running, and most highly respected physician-only MBA in the country. It has over 700 graduates. And, the program only takes one year to complete. 

By joining the UT Physician Executive MBA, you will develop the business and management skills you need to find a career that you love. To find out more, contact Dr. Kate Atchley’s office at (865) 974-6526 or go to nonclinicalphysicians.com/physicianmba.


Becoming a Medical Affairs Leader

John and Dr. Chadha discussed the topic of advancing one's career in the field of Medical Affairs. Savi provided his unique insights and shed light on strategies for listeners who aspire to fast-track their career growth.

  1. Proactivity: Being proactive is crucial for career advancement. Expressing interest in tasks, taking the initiative, and letting your manager know about your aspirations are key steps.
  2. Leadership: Stepping up as a leader within your team showcases your initiative and can accelerate your career progression.
  3. Management Experience: Gaining experience in managing other team members, by onboarding or participating in employee training can be valuable for career growth.
  4. Certification: Pursuing the MSL certification shows dedication and expertise in your role. 

Remember, your initiative, leadership skills, job knowledge, and relevant certifications all play a role in accelerating your career.

Strategic Tips for Starting Your MSL Career

When seeking opportunities in the field, engaging with pharmaceutical representatives can prove highly advantageous. These professionals regularly visiting medical offices and hospitals are sources of valuable information and pathways to meaningful networking.

Taking the initiative to connect MSLs and sharing your resume if job openings arise, can create a pathway into these nonclinical roles. This often-overlooked resource can open doors to new career prospects.

Dr. Savi Chadha's Advice

Be persistent and patient. Transitioning takes time. It may not happen right away; it could take months or even years. Don't take rejection personally; stay resilient and work through it. Despite the stress prompting the transition, give it the time it needs.

Summary

Dr. Savi Chadha's insights provide advice for those aiming to excel in Medical Affairs. As a seasoned Medical Science Liaison (MSL), his journey from entry-level to senior positions offers a unique perspective.

He emphasized proactive engagement, leadership, and expanding skillsets. Additionally, he encourages listeners to persist in the journey towards nonclinical roles with patience, persistence, and “thick skin” to achieve that goal.

NOTE: Look below for a transcript of today's episode. 


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Podcast Editing & Production Services are provided by Oscar Hamilton


Transcription PNC Podcast Episode 315

Develop These Essential Skills to Be a Visionary Medical Affairs Leader

- Interview with Dr. Savi Chadha

John: Today's guest was the first MSL I ever interviewed almost five years ago on episode number 50 of the podcast. And I'm really happy to have him back with us to provide his insights and his advice about working in the pharma industry. So, welcome back, Dr. Savi Chadha.

Dr. Savi Chadha: Thank you very much, John. Great to be here. Great to be back.

John: It's good to see you. I have a lot to follow up on with you. I know you were so helpful the first time we talked. I don't have too many guests that have been in pharma, a new job with pharma and moved up the chain and that kind of thing. Maybe at the most it might be one other person. So I'm really glad you can help us today.

Dr. Savi Chadha: I'm glad I could do it. I'm glad I can be here.

John: Now my audience can go back and listen to the original episode. But why don't you go ahead and give us the short version of what you were doing before you became an MSL and then basically how you landed your first job, and then we'll take it from there.

Dr. Savi Chadha: Sure. Well, I think like a lot of your audience members, I was a clinician. I was going to the hospital, writing, seeing patients, and I think like a lot of physicians these days, I was starting to lose some of my satisfaction with the work. The same frustrations that I think a lot of us have, in terms of day-to-day patient care.

A friend of mine, actually, he had made the transition from clinical work into the MSL world. And he knew about my background. He knew that I had some business experience before I went to medical school. I actually worked in advertising. So he knew that I had some good relationship building skills. And so, he introduced me to the MSL role.

After quite a bit of thought into it, I started doing more research into it. And eventually I decided to take the plunge and I started interviewing, researching, and networking was a big one. And eventually, back in 2016, I did land my first MSL position, and I've been working as an MSL ever since.

John: Excellent. Looking back, if you have any pearls of wisdom about getting your first MSL job? We're not going to spend a lot of time on that, but anything that you would put out there in terms of advice for physicians looking for that?

Dr. Savi Chadha: Yeah, I would, and this is a question I do get a lot. Getting an MSL job is plain and simple. It's a competitive type job. There are a lot of people applying in addition to us, MDs and DOs. PhDs apply, PharmDs apply, and now the field is taking more advanced practitioners, so nurse practitioners as well as physician's assistants.

So, it's becoming more and more competitive to get MSL jobs. That being said, as MDs we certainly bring a wealth of knowledge and a lot of experience to that. Even though it is a competitive landscape, I encourage people to be confident in their interviewing abilities and their skills, and also to have a good amount of patience and fortitude because I think most people I've spoken to did not get their first offer, or I should say did not get their first interview, excuse me. And it was disheartening.

The trick I think for a lot of people is not to personalize rejection. Just maintain your focus, stay the path, if you will, and be patient and just be persistent. I think in most cases, the people that I've talked to that have made it or that have succeeded, have done that.

John: Well, I think that is a job where you can't have an MSL degree or something that's going to say, "Okay, you're the perfect person for this job", from what I know. You learn a lot. You could learn when you're interviewing, you learn when you're looking at job descriptions. I think it would make sense, correct me if I'm wrong, but to join the MSL society, even if you're not an MSL, because they have things that support people looking for that job, I believe.

Dr. Savi Chadha: They do. And I utilized them when I was searching, and I still work with them regularly. They have a wealth of information. In terms of both, about the MSL position itself and in terms of landing a position, interviewing, they go into a lot of detail. They're a great resource, fantastic resource.

John: Yeah. It's not like looking for your first medical school app job. Not a job but getting into med school, getting to your residency. There's kind of a prescribed process for that, but switching to a new career like this can be somewhat scary and the unknown.

Dr. Savi Chadha: It certainly can be. Especially in healthcare, I think a lot of our career paths have a strongly laid out career path. And this certainly goes off that beaten path, and we're sort of shredding our own way. So, it can very much be anxiety inducing.

John: Now you've been doing this job in different forms for a while. So, has it lived up to what you thought it would be? That would be of interest to us.

Dr. Savi Chadha: I'd say, yeah, I would say it has. It's a very enjoyable, satisfying job. In terms of being at the sort of cutting edge of clinical research, I get exposed to the newest treatments in my therapeutic area. I find out what clinical trials are going off or what new drug out there. So that's really fascinating. It's really nice actually to really have that excitement and enthusiasm of a new product coming out to treat a disease. From that aspect, it's certainly very satisfying and I think that's always been there. I foresee that always continuing to be there. That's just in the nature of the position.

John: Now, from talking to yourself I think previously and others, I've heard that it can have a fair amount of travel involved. It's just part of the job, although it can vary depending on whether you have a giant territory or a small territory or what have you. But has that changed at all in the last five years? I know with the pandemic a lot of nonclinical jobs where they're allowing them to do more remotely. So, tell us what that's like right now for you, or has been.

Dr. Savi Chadha: That's actually a great question, and certainly the pandemic had a very significant impact on MSLs day-to-day activity. All of our in-person discussions moved online, like I think many peoples are. Now that the pandemic has sort of wound down, a lot of us are back in the field. So, we are meeting with clinicians and researchers in person. That does require a lot of travel which is very much similar to what it was prior to pre pandemic. So it certainly has gone back to that model. Yeah.

John: Okay. I'm sure it varies by, again, the situation. That's just something to remember. But now you have been working there, and I know you ended up switching companies and now you've got some different roles. So, why don't you explain what's happened over those last five years for you?

Dr. Savi Chadha: Sure. Yeah. I think as I've been there at my current company longer, I've certainly gotten more projects and more type of administrative roles given to me. And some of these things are projects like interviewing new potential MSLs, training new MSLs, and then certainly managing them as well. Those are some of the things that I do in terms of my current MSL team.

Additionally, I also go outside of some medical affairs and do other aspects I should say within medical affaire but aside from just working with my MSL team. I also do work a lot with our promotional review committee. Any type of material that's printed, any type of advertisement that people see in terms of a pharmaceutical company or a product, I have to approve that and make sure that any claims that are made on there, specifically scientific claims or clinical claims, that they are backed up by clinical research and that they are 100% truthful. Additionally to that, I also do advisory boards, and I put those together and quite a bit of speaking engagements too. In addition to MSL work, there's other projects I should say that I do.

John: Now, can you explain a little bit about how the medical affairs division in a pharma company is structured? Most of us, it's really a black box. When we look in, it's like, "Okay, what the heck? I know an MSL might be in there, there might be medical directors, but what are they medical directing?" Maybe you can give us an insight into either the way it's set up in your company and or other companies if you're aware of how they typically structure things.

Dr. Savi Chadha: Sure. One easy way to say it is I think most people are familiar with pharmaceutical reps. They can go to physician's offices. I think a lot of us know about them. And then pharmaceutical companies also have clinical research teams, entire research divisions.

We tell people, and what I tell people is that medical affairs would be fall sort of in between those two divisions. And what I mean by that is, oftentimes the clinicians will ask the reps questions that the reps may not have the immediate information on and may not be able to answer right away. So what they'll do is they'll say "Let me refer you to our in-house medical liaison."

And so, we in medical affairs work a lot with the current products that are already on the market, whereas clinical research oftentimes will be working with products that are still in maybe phase one or phase two trials. Those products are usually not on the market as of yet. What we can do is we provide medical support for products that have already been FDA approved and are currently being utilized by clinicians.

John: Okay. I know the MSLs work with sometimes they're called key opinion leaders. I don't know, what term do you use in your company for your context?

Dr. Savi Chadha: Across the industry, KOL, which is what you said, key opinion leader, that's the most common one. But different companies will use different terms. Some will say thought leaders, some will say stakeholders. There's a lot of different terms for it.

John: Okay. So in the way you're set up now is that anything that's been approved and is out there in the market. You definitely can have those conversations. But when it comes to having conversations about things that have not been approved by the FDA that would shift to somebody else or would that be something that the MSL could talk about as well?

Dr. Savi Chadha: That's actually a great question, and that is actually something that we MSLs can do. And because clinicians do frequently ask about the company and say, "What products do you have in the pipeline, can you tell us a little bit about them?" And the commercial division and members of the commercial team due to legislation are not allowed to say, speak on that. Whereas as in medical affairs, we can. That's what I mean when I say that we're sort of a bridge between clinical research on one hand as well as commercial on the other. We support the commercial, and yet we can also talk something about the clinical.

John: All right. Because I was a little bit confused about that. But that makes sense because it's all about education, right? And to your KOLs, it's really not promotional at all. And the FDA doesn't like it if you ever do anything promotional on that side of the equation. But you're strictly by the book. But if it's scientific, if there's evidence for it, you can discuss it from what I've heard.

Dr. Savi Chadha: That's correct. Yeah. If it's scientific, we absolutely can discuss it. Yeah.

John: You've got a little bit more responsibility it sounds like in what you're doing. You got some seniority. Tell us a little bit more about that. What other things you might be doing? If somebody is in a position that you were in five or six years ago, are there things they can do to help get that kind of experience and maybe what you're even looking forward to doing in the future?

Dr. Savi Chadha: I would say for somebody, if they're sort of a new MSL, if they're looking to advance their career, certainly being proactive it goes without saying. As in most careers, being proactive about letting your manager know that you want whatever said task that they have. Certainly stepping up and being a leader on your team is big and can be very useful to your career. And that shows initiative, that shows proactivity, and certainly obviously it shows leadership. Also if you've managed say another employee or assisted another employee in terms of interviewing them, in terms of getting onboarding, those would also certainly be very, very useful. Onboarding specifically.

John: Now, I think looking at your LinkedIn profile, I saw that you've actually taken some additional steps to become board certified. And so, what was that about? What was included in that kind of education and did it have leadership and management components to it? Or was it all focused specifically on the job that you do as an MSL?

Dr. Savi Chadha: It's been a little while since I had got my MSL certification, but from what I remember, it required a written examination that talked a lot about some of the different roles and some of the different aspects of being an MSL and what MSLs are legally allowed to say and are legally not permitted to discuss, and how we can bring about those discussions.

I remember the test had a lot to do with that in terms of how we can appropriately bring about those discussions. The certification also required a certain amount of work experience at that point in order to receive the certification. So, it was a combination of knowing, I would say the job itself and what it entails and what it does not entail. And then having an appropriate amount of work experience already under one's belt, if you will.

John: Now, I have to assume at some point some people in your position will end up getting even more into the management side of things, leadership and that sort of thing. A couple of questions about that, if you know the answer. One is, is it beneficial or less beneficial to be a physician as opposed to let's say a PharmD or an RN or a master's nurse or other specialties in terms of the leaders? Who do you see are the leaders? Is it more of the physicians or not necessarily?

Dr. Savi Chadha: It really runs the gamut, really truthfully. I look at my managers and I look at managers in other companies, and it really does run the gamut. Some are MDs, some there are DOs, lots of PharmDs, certainly. That's simply because PharmDs make out the most MSLs. So inevitably simple math there. But there are PhDs. I've had nurse practitioners who were managers who were great. It really does run the gamut. The degree is really secondary to people's both hard and soft skills once they get in.

John: I'm trying to get a little more insight into the rest of the medical affairs division. You kind of explained this. The way I look at the medical affairs is responsible for getting the new drug out into the world, I guess is how I look at it. I see these ads for assistant medical directors, medical directors, associate medical directors, executive medical directors. It's kind of nebulous terms. So is it they just have more responsibility in a bigger scope of people reporting to them? Is that basically what that means? Or is there some other key that we should be aware of?

Dr. Savi Chadha: I think you sort of touched on it. An associate director usually will be joining, maybe that's their first directorial level position. They'll be labeled as associate and maybe not have full director type responsibilities. As they gain more experience, then maybe they become a director and then maybe eventually senior director. I think you touched on it, it's really just the volume and intensity of the types of projects that they're given and trying to manage.

John: All right. I'll put you on the spot now a little bit, even more than I already have. I'm just trying to think of other advice you can give to physicians or even other clinicians because I do have some nurses and pharmacists and dentists that listen.

But in terms of preparing for that first MSL job, but then maybe even learning some things prior to be getting your first MSL job that might help you later on, move up the ranks. Any thoughts or suggestions on that?

Dr. Savi Chadha: Yeah, I would say a couple of things. I would say to really talk to their drug reps that come to their offices or their hospitals. They are an excellent, excellent resource in terms of information and in terms of just networking a segue in. They can ask their reps, if they have a medical liaison that they work with. If so, ask to speak to them, get to know them. It wouldn't hurt to maybe give them a copy of your resume if they're hiring. Who knows, maybe they're hiring. That is an easy segue that's kind of laid out right there. So, I think that's a resource that people have that's often overlooked.

John: Yeah. I've at least spoken with one person whose job came directly from talking to the drug rep when they were still clinically practicing. And then actually just within a year she became an MSL and it's like, "Okay, that worked out well, but it's not always that simple."

Dr. Savi Chadha: You're right, it certainly is not that simple. That being said, it is an avenue that's available. There are other avenues. I think that if that's an avenue that's right there, that's proverbially sitting right under the bed, if you will, you might as well take advantage of it.

John: I think part of the issue was for her, it was that some of her colleagues ended up being KOLs. So, it was built in, she became an MSL and she was calling on those very people that she used to interact with. I think the company thought this would be a good hire, but it doesn't work like that very often from what I've heard.

Dr. Savi Chadha: Yes and no. I would say it can be an asset in terms of our professional network. I can pretty confidently say that will not be the only network that she will talk to. It will certainly have to expand.

John: Yeah, and what are the odds that you're going to just happen to live in an area that happens to need an MSL who's not already working there and for that company. Still, it's worth it. Definitely you can learn a lot from your rep from what I've heard. So I'm glad you definitely second that.

Anything else that we're missing in terms of the job, applying for the job? Do you see a lot of your colleagues doing lateral moves to other companies? Or do most people try to work their way up in one company and then later on do a switch?

Dr. Savi Chadha: I would say generally I see a lot of lateral moves, primarily for a few different reasons. One, when they become an MSL, a lot of people are simply satisfied with the MSL itself. They don't have an intention or any interest in going into management, which is perfectly fine. In that case lateral moves happen more often.

Generally what I've noticed is that if somebody moves vertically, they do generally move vertically within their own company and then move laterally. So, it's not too common where I've seen somebody do both a lateral and a vertical at the same time.

John: Well, I think I've picked your brain pretty darn well here for the last half hour. Any words of encouragement you want to give to the listeners too? Because most of my listeners are a big percentage. They've been trying for a while to get a nonclinical job, or they're just getting started. They're kind of frustrated working in the hospital situation or even a clinic situation with long hours and working with EMRs and the risk of being sued. Any advice for those people who are still maybe in that early phase?

Dr. Savi Chadha: I would say don't lose heart. If you're persistent, I know it's hard because people oftentimes want to transition during very stressful times in their career, and they want out pretty quickly. The transition does take time. Most people I've talked to, it didn't happen right away. It takes them months, sometimes years. It's just patience, persistence, and fortitude. Don't personalize rejection, have thick skin to work through it I would say. I know it's hard. I know it's not easy. I know that the very reason they want to transition is because they're stressed out at their current job but it does take some time regardless.

John: I think that's good advice because when we're in a big hurry sometimes we make mistakes that end up being worse than the solution that we would've gathered if we just gave it some time and really figured out what we wanted to do instead of run away from something. So, that is definitely excellent advice.

All right, Savi, this has been really good. It's been great to catch up with you and we'll put it on the books to get back together in five years.

Dr. Savi Chadha: Thank you for having me.

John: I really appreciate the time you've taken to come in and share all that. Best of luck, continued luck and success in your work in pharma. It sounds really good. So with that, I'll say goodbye.

Dr. Savi Chadha: Thank you so much. I appreciate it, John. Thank you again for having me.

John: You're welcome. Bye-bye.

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Doctors Should Explore One of These 4 Unique Nonclinical Careers – 245 https://nonclinicalphysicians.com/4-unique-nonclinical-careers/ https://nonclinicalphysicians.com/4-unique-nonclinical-careers/#respond Tue, 26 Apr 2022 11:35:47 +0000 https://nonclinicalphysicians.com/?p=9558 My Latest Discoveries In today's podcast, we review 4 unique nonclinical careers. Each is open to just about any physician with some clinical experience. And there is a specific training program available for each. That training will teach you how to prepare for and land your first job in the field.  These four [...]

The post Doctors Should Explore One of These 4 Unique Nonclinical Careers – 245 appeared first on NonClinical Physicians.

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My Latest Discoveries

In today's podcast, we review 4 unique nonclinical careers. Each is open to just about any physician with some clinical experience.

And there is a specific training program available for each. That training will teach you how to prepare for and land your first job in the field. 

These four unique nonclinical careers all share the following features:

  • they can be started part-time while still performing your current job;
  • they can all be done remotely, for the most part;
  • there are professionals who can train you.

Our Sponsor

We're proud to have the University of Tennessee Physician Executive MBA Program, offered by the Haslam College of Business, as the sponsor of this podcast.

The UT PEMBA is the longest-running, and most highly respected physician-only MBA in the country. It has over 700 graduates. And, the program only takes one year to complete. 

By joining the UT Physician Executive MBA, you will develop the business and management skills you need to find a career that you love. To find out more, contact Dr. Kate Atchley’s office at (865) 974-6526 or go to nonclinicalphysicians.com/physicianmba.


4 Unique Nonclinical Careers

1. Episode 127 with Dr. Nicole Rochester

The job title is Independent Health Advocate. It is similar to a health navigator. You will provide a variety of customized health advocacy services. You will help patients and their caregivers navigate the complicated healthcare system.

In this role, you will use your understanding of the healthcare system and clinical medicine to assist patients and their families in several ways.

  • Provide administrative support, helping patients understand what they need to do to access their insurance benefits and overcome insurance denials.
  • Translating medical jargon into understandable information about their options for care, and the indication and side effects of their medications.
  • Speak directly to physicians to help patients better understand their prognosis and treatment options.

If you’re interested, go to Dr. Rochester's website at yourgpsdoc.com and navigate to her contact page.

2. Episode 134 with Dr. Shirag Shemmassian

Shemmassian Academic Consulting reviews and edits essays, and advises clients on curricula to pursue. The goal is to optimize the chances of admission to a top-ranked university, medical school, or residency program.

To best qualify for this unique job you must demonstrate:

  • Intimate knowledge of the admissions process (admissions committee experience is a plus);
  • Excellent written and communication skills;
  • Exceptional patience, empathy, and warmth;
  • A degree from a top-25 university;
  • Current or past enrollment in a prestigious residency or fellowship program;
  • Completion of Shemmassian’s evaluative interview process and training.

To find out more, go to www.shemmassianconsulting.com/join-our-team, or send an email to jobs@shemmassianconsulting.com.

3. Episode 227 with Dr. Armin Feldman

Dr. Feldman offers training as a Medical Legal Consultant. The consulting is pre-litigation and pre-trial in nature. The consultant helps attorneys manage the medical aspects of cases, increase case value and save attorneys' time. This helps attorneys to negotiate and settle cases and get the appropriate medical care for their clients. This job does not require participation in medical malpractice cases.

The work mostly involves personal injury and worker's compensation cases. 

Dr. Feldman has created a comprehensive coaching program for physicians interested in learning how to do this work. You can watch a short video by Armin and learn more at mdbizcon.com.

Episode 238 with Dr. Paul Hercock

Mantra Systems employs physician consultants with European Union MDR expertise to do a variety of duties for its client medical device companies. The entry-level position is called Medical Affairs Associate.

Those services include things like:
•  Clinical Evaluation Report-writing services.
•  Regulatory Medical Writing services designed for EU MDR compliance.

The easiest way to find out about the EU MDR and the Medical Affairs Associates Program is to use this link: nonclinicalphysicians.com/mantra

Summary of 4 Unique Nonclinical Careers

In this episode, John presents four unique nonclinical careers that most medical school graduates can consider. Some also require at least a few years of clinical experience. They can be started part-time, and grown to full-time. And most can be done remotely on your own schedule.

NOTE: Look below for a transcript of today's episode.


EXCLUSIVE: Get a daily dose of inspiration, information, news, training opportunities, and amusing stories by CLICKING HERE.


Links for Today's Episode:

Download This Episode:

Right Click Here and “Save As” to download this podcast episode to your computer.

If you enjoyed today’s episode, share it on Twitter and Facebook, and leave a review on iTunes.

Podcast Editing & Production Services are provided by Oscar Hamilton


Transcription PNC Podcast Episode 245

Doctors Should Explore One of These 4 Unique Nonclinical Careers

John: You're listening to Physician Nonclinical Careers with John Jurica, the podcast that inspires, encourages and teaches physicians how to pivot to a new career. I'm here to help you pursue a career that brings you joy and harnesses your zone of genius.

Episode number 245 - Doctors should explore one of these four unique nonclinical careers. If this is your first time listening, well, then welcome aboard. Every week I bring you an interview or a solo presentation to help you find a part-time side gig or land an alternate full-time job. If you like what you hear, share this podcast with a frustrated friend or colleague. For those who've been with us before, let me ask you this. Have you written a review of the podcast? No? Then please do me a favor. Scroll down on your smartphone when you're in the podcast app and leave a rating and a review. I'll really appreciate that. And it helps to keep us going.

For today's presentation, it's just me reviewing the specifics of four unique nonclinical jobs that I have encountered during the past few years. Some of you I know aren't looking for a traditional nonclinical career in a sense in hospital management, pharma, medical writing, consulting, or utilization management. Those are the big industries that typically employ physicians nonclinically. But if that's you and you don't want to do one of those, I think you'll find all of these very intriguing jobs, something to consider. The other reason that I single these out is because there are specific training programs available for each that will teach you how to prepare for and land your first job in the field.

Now, before we get to the interview, if you want to connect with me and hundreds of other colleagues, developing alternative careers, the best thing you can do is join us in Newscript where you can write a new script for your career and your life. It's an online forum and repository of interviews, written resources, courses, and livestream events, all in one place, right there in your smartphone. It's private, uncensored and free with a growing panel of expert mentors.

You get it at a monthly subscription cost. That's less than a single cup of coffee and a donut for an entire month, still under $5 per month as of me recording this today. Now, if you listen to this down the road in a few months or a year, it probably will be at a higher price because as the community grows, the cost of becoming a member will increase. In the meantime, just go to newscript.app to join hundreds of clinicians writing a new script for their lives.

Now it's time to thank our wonderful sponsor. An MBA can be very helpful for certain nonclinical careers, and for those already in practice, an executive MBA is probably the best option. Our show sponsor, the University of Tennessee, offers the longest running and most highly respected physician only executive MBA in the country. In fact, it has produced more than 700 graduates and for some career pivots, you really need that MBA. The ASM college of business at UT was recently ranked number one in the world by Economist magazine as the most relevant executive MBA program.

And it's efficient, unlike most other programs, which run about two years in length, the UT PEMBA only takes one year to complete. And while you're there, you'll complete a company project while working on the MBA, which will help you to demonstrate the value of the degree while you're still in the program.

Graduates have taken leadership positions at major healthcare organizations and have become entrepreneurs and business owners. If you want to acquire new business and management skills and advance your nonclinical career, then contact Dr. Kate Atchley's office at (865) 974-6526 or use our link at nonclinicalphysicians.com/physicianmba.

Nonclinical nation, as I mentioned, I want to review today four unique nonclinical careers that all share the following features. That can be started part-time while still performing your current job, that can all be done remotely for the most part. And there are professionals who are doing the job who will teach you how to do the job as well.

The first job was discussed way back in episode 127 with my guest Dr. Nicole Rochester. Dr. Rochester is the founder and CEO of Your GPS Doc, LLC. A health advocacy company whose mission is to educate and empower patients and family caregivers so they can navigate the healthcare system.

Nicole was inspired to launch her company after caring for her late father. She uses her inside knowledge of the healthcare system to advocate for her clients, thereby overcoming the barriers that interfere with timely effective patient-centered medical care.

Nicole is a nationally recognized speaker, best-selling author and media expert. When I first spoke with Nicole and I heard what she was doing, I really became intrigued and thought that this could be a very fulfilling career for other physicians because we like to help patients and we're to trying to get away from the clinical mess that we're in sometimes with the electronic medical records and other aspects of modern medical practice. And by being a healthcare navigator or advocate, you definitely can be helping patients.

She calls this position that of an independent health advocate. It's similar to a health navigator that some hospitals employ, kind of similar to a case manager in a way, except that case managers are either working for a system or working for an insurance company. But as an independent health advocate, you are working for the patient and the patient's family generally. In doing so, you will provide a variety of customized health advocacy services to help the patients and their families and help them navigate the complicated healthcare system, of course, that they find themselves in, in the United States.

In this role, you will use your understanding of the healthcare system and of clinical medicine to assist patients in several ways. Let me list a few of them. You might provide administrative support, helping patients understand that they need to access their insurance benefits and overcome insurance denials in certain ways. Those are the things we come into contact with constantly while taking care of patients. You'll be translating medical jargon into understandable information about their options for care and indications and side effects or their medications.

For families and patients who are faced with a really serious illness or an uncommon illness, patients can use you to speak directly to their physicians and review their medical records and help them better understand their prognosis and treatment options. These are things that really a physician would be best at, even other professionals in the medical field can't really understand the nuances of the discussions to the extent that a physician would.

In this role, you're paid to integrate the information for patients with serious illnesses, so they can make more informed decisions about their care and have a clearer understanding of the consequences of their illness and its treatment. To do this job, you may need to attend medical appointments in person, but often it can be done virtually. You can do things like compare assisted living, rehabilitation, long term care, nursing home facilities, and home care agencies, and then provide your advice to the clients about which would be the best for you.

Basically, you'd be using your medical background in education to research treatment options and alternatives, especially in those various serious illnesses. The work can be very rewarding. And as I noted a minute ago, it's mostly done remotely. Generally, in this kind of business like the others discuss today, you're going to be serving as an independent contractor and small business owner. The overhead is negligible. You're paid as a consultant, usually at an hourly rate.

Now, when I last spoke with Nicole, she was mentoring and teaching other physicians to become independent health advocates. If you're interested in learning more about how to do this, the quickest way is to contact her directly. You can go to her website at yourgpsdoc.com and then navigate to her contact page and send her a note. You could probably also reach out to her on LinkedIn.

Now, the second unique job I want to present today was described to me by my guest, Dr. Shirag Shemmassian. Now in episode 134, I learned that there's a growing need for young physicians to serve as part-time consultants and advisors to high school and college students and med students really, as they prepare to compete rather for positions in universities and medical schools and residencies.

Shirag is not a medical doctor. He's actually a psychologist who completed his undergraduate work at Cornell and masters in PhD at UCLA. And he wasn't sure what he was going to get into. But about 20 years ago, he began doing some part-time coaching and advising students to help them with admissions to universities and professional schools. And he kept having more, more people ask him to help with those kinds of activities. So that in 2013, he formally opened the Shemmassian Academic Consulting company, which now employs dozens of academic consultants and assists hundreds of students each year.

What do these consultants do? Well, just like he was doing, they provide remote coaching and mentoring of students who are preparing to apply to universities, medical schools and residencies. And in that role, they review and edit essays. They advise clients on courses and curricula to pursue, to optimize their chances for admission. And usually, they're focusing on admission to the top tier schools.

To best qualify for this unique job, you must have an intimate knowledge of the admissions process. If you have experience on an admissions committee, that'd be a great plus. You have to have excellent writing and communication skills. You have to have exceptional patience, empathy, and warmth. You should hold degrees from a top 25 university or a top medical school. You should be currently enrolled or completed a highly ranked residency or fellowship program. And then to get going, you have to complete the Shemmassian's evaluative interview process and the training they provide.

This is the first time I've ever talked to an academic consulting type position, someone doing that and also teaching it. I found it very interesting and this probably is not open to those who are more than just a few years out of their residency or fellowship. But if you've been involved in academic institutions and teaching, if you've been on an academic review committee, then it's really something worth thinking about and Shemmassian's company will help prep you for this and teach you how to do it.

And then of course has jobs right there for you to pursue. You can learn more about this at the website www.shemmassianconsulting.com. If you add the suffix join-our-team, that's the tab that'll take you actually to the contact form to get in touch with them. Shemmassian is spelled with two M's and two S's. It's www.shemmassianconsulting.com and you will find out how to learn more about that job.

The third of our unique positions is that of medical legal consultant. I was introduced to this work by Dr. Armin Feldman in episode 227 of this podcast. Armin completed his training in psychiatry at the University of Colorado Health Sciences Center. And he practiced psychiatry and psychoanalysis for over 20 years.

But he began doing a unique kind of medical old legal consulting about 20 years ago. And for about 14 years, he devoted himself professionally entirely to this type of service full time. And then 12 years ago, he began training other physicians how to do the same thing that he was doing through his medical legal consulting coaching program. And it is different from medical expert witness consulting.

To be a medical expert witness, you should really still be in practice and you will provide three primary services. You'll be doing chart reviews, depositions, and courtroom testimony if you're an expert witness. But Dr. Feldman's consulting is pre-lit litigation and pre-trial in nature. So, he's helping attorneys manage the medical aspect of cases, increasing case value and saving attorney time. In other words, he's using his medical expertise to kind of show the attorneys the pros and cons in this case, should it be pursued, should it not be pursued? He's helping attorneys negotiate and settle cases and get the appropriate medical care for their clients, but he doesn't participate in medical malpractice cases.

He's not really doing expert witness work. He does not do depositions and he doesn't do any sort of testimony at trials. Part of the reason is the work mostly involves personal injury and workers' compensation cases. And really what you're doing is you're reviewing available information, medical records and the history of the cases and so forth. And you're doing research on the actual injury or illness that has occurred and using that information to educate the attorneys who then have to decide how they're going to approach that case. And so, unlike expert witness consulting, you don't have to be an active practice or even have an active license.

And the other thing is that Dr. Feldman is a psychiatrist. He really doesn't have extensive knowledge in orthopedics or occupational medicine or that kind of thing. But everything that he has learned in order to provide the expertise for the attorneys that he needs to provide them just comes from research and his medical background, 90% of which just came through medical school from what he tells me.

Similar to these other jobs, he works as an independent consultant, probably forming an LLC to do that. Set your own hours and you work remotely. And it's really not limited to any specialty. It can be started part-time and grown and like medical expert witness consulting, it pays better than the other positions I'm describing in today's episode.

Now, as I said, Dr. Feldman created a comprehensive coaching program several years back, and he's actually had over a thousand physicians go through it. Using his course, you can learn how to do this work and grow your consulting business. And so, it sounds pretty intriguing to me. You can learn more by watching a short video by Armin and learn more about it at mdbizcon.com.

Well, this brings me to the fourth and final unique job I want to present today. It was described by Dr. Paul Hercock in episode 238 of the podcast. Actually, he was on my podcast twice, and number 238 was his most recent visit. He's an author, entrepreneur and an educator. Actually, the first time we talked to him, we talked about his book.

But he started personally serving medical device companies several years ago. And this kind of grew out of the recent adoption of the MDR regulations in the European Union. And since they've adapted these new sets of rules and regulations, the need for more physicians to serve in a variety of roles to help medical device companies comply with them has grown tremendously. Paul runs a company called Mantra Systems that employs physicians like this, who are consultants with EU MDR expertise to do a variety of duties for its client medical device companies. And the entry level position that we mostly spoke about was called the medical affairs associate.

Now these medical affairs associates do things like the following for their clients. They do the actual clinical evaluation and clinical evaluation report writing, in which they do extensive data analysis and they use their medical writing expertise. They also do regulatory medical writing services, again, that are designed to meet the MDR regulations. Again, with this new adoption, the demand for these experts has been so high that he ended up developing his own program to train physicians to provide those services. At first it was limited, but he has created an extensive set of courses or lessons within his program to train physicians how to help companies such as medical device companies and contract research organizations meet the MDR requirements.

And like the other three jobs described today, it's a remote part-time position that can ultimately become full-time if desired. It pays well, and really is actually open to physicians in the US as well as the UK. And there are several other international locations where these same regulations apply or where the medical device companies have headquarters or locations where you could do this.

So, you can complete your training and apply for a position with Mantra Systems itself or with other medical device companies or contract research organizations that support the medical device companies. The easiest way to find out about the EU MDR and the medical affairs associates' program is to use this link that I created nonclinicalphysicians.com/mantra. I made that back when I was talking with Paul.

Let me wrap up now. These are four pretty unique and interesting nonclinical careers and jobs that I wanted to present. They can all be started part-time and performed remotely. They're all open to physicians from almost any specialty. The other thing I wanted to mention is I'm not an affiliate for any of these training programs, so I don't have any financial relationship. I will say that Mantra was a sponsor for two episodes of my podcast. But other than that, we have no ongoing relationship. I just think these are unique, interesting, and potentially well-paying part-time jobs that can be done remotely that physicians should take a look at. Now, all the links that I mentioned today and a transcript of this episode can be found at nonclinicalphysicians.com/uniquenonclinicalcareers.

Let's see, before we close, let me remind you about Newscript. It's a community of clinicians writing a new script for their careers. We're still accepting new members, of course, and the membership is very low cost. There's really a lot of free content in there once you're a member. There are live streams I'm doing weekly and they're recorded. So, there's probably at least 20 of those. They're all about nonclinical and non-traditional careers and some business topics, management and leadership.

Tom posts all the time. We have now about eight mentors covering things like locum tenens, an expert in SEO who's a dentist, I believe. Mark Leads is his name. We have pharma experts. We have book authors. There's a lot in there already, and it's going to continue to grow. So, it's really foolish not to check it out at newscript.app and consider joining now before the cost jumps up. Once you've locked in your payment level, you can keep that forever.

Remember that the podcast is made possible by support of my nice, wonderful, ongoing long-term sponsor, the University of Tennessee Physician Executive MBA program. If you're seriously thinking about going for an executive MBA, you definitely should check out the UT at nonclinicalphysicians.com/physicianmba. I'll remind you that I do use affiliate links from time to time, which I receive a payment from the seller, but there shouldn't be any in today's episode, or on the blog or website.

The opinions expressed today are just mine while the information provided in the podcast is true and accurate to the best of my knowledge. There's no guarantee that using the methods discussed will lead to success in your career, life or business. Always consult an attorney, accountant or career counselor or strategist before making any major decision about your career.

Now, usually at this point, at least recently, I've been trying to give you a teaser about what the upcoming episode will be. I'm in a weird situation now because I'm moving from where I've lived with my wife for the last 20 plus years into a new home. So, we are in the middle of packing everything up, and I'm falling behind a little bit on my episodes here, but I have some very interesting guests coming up in the next few weeks.

I just don't know who's going to be up next week because I haven't recorded it yet, but I hope to be interviewing Dr. Lynn Marie Morski who's been on here before. But since we spoke with her, she has become the founder and president of the Psychedelic Medical Association. And I want to learn about how different kinds of what used to be totally avoided medication and controlled and so forth, which they still are, but how some of these psychedelics and cannabinoids and ketamine and other things are being used in new ways for PTSD and depression and other things. So, she'll be coming on the podcast soon.

I'm talking to a physician and she'll be on the podcast who is running basically a nonclinical career website with all kinds of free resources, but she's in the UK. So, doing a lot in the nonclinical career area and I just discovered her in the past month or so. So, she'll be coming on the podcast. And then there's another, again, international physician who teaches health wellness in yoga instruction. I think she was a family physician and she'll be coming on. I've got some interesting episodes coming up and I don't want to belabor that anymore. I really thank you for listening here to the very end and I will see you next week. Bye-bye.

Disclaimers:

Many of the links that I refer you to are affiliate links. That means that I receive a payment from the seller if you purchase the affiliate item using my link. Doing so has no effect on the price you are charged. And I only promote products and services that I believe are of high quality and will be useful to you.

The opinions expressed here are mine and my guest’s. While the information provided on the podcast is true and accurate to the best of my knowledge, there is no express or implied guarantee that using the methods discussed here will lead to success in your career, life, or business.

The information presented on this blog and related podcast is for entertainment and/or informational purposes only. I do not provide medical, legal, tax, or emotional advice. If you take action on the information provided on the blog or podcast, it is at your own risk. Always consult an attorney, accountant, career counselor, or other professional before making any major decisions about your career. 

The post Doctors Should Explore One of These 4 Unique Nonclinical Careers – 245 appeared first on NonClinical Physicians.

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Use These Simple Tactics to Land a Fantastic First Pharma Job – 209 https://nonclinicalphysicians.com/first-pharma-job/ https://nonclinicalphysicians.com/first-pharma-job/#comments Tue, 17 Aug 2021 10:00:09 +0000 https://nonclinicalphysicians.com/?p=8089 Interview with Dr. Marsha Caton Our guest today shares tested strategies to enable physicians to find their first pharma job.  Dr. Marsha Caton obtained her M.S. in Biology and Ph.D. in Human and Molecular Genetics at the Albert Einstein College of Medicine. She has worked in the pharmaceutical industry for many years. She [...]

The post Use These Simple Tactics to Land a Fantastic First Pharma Job – 209 appeared first on NonClinical Physicians.

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Interview with Dr. Marsha Caton

Our guest today shares tested strategies to enable physicians to find their first pharma job. 

Dr. Marsha Caton obtained her M.S. in Biology and Ph.D. in Human and Molecular Genetics at the Albert Einstein College of Medicine. She has worked in the pharmaceutical industry for many years. She is an expert in managing NDA submission teams and delivery of regulatory documents for drug approval.

Dr. Caton has expertise in medical writing, medical affairs, pharmacovigilance processes, health authority responses, and regulatory guidelines. Her experience working in pharma runs the gamut from scientific consultant, medical writer, and clinical research associate, to medical affairs specialist and pharmacovigilance scientist.


Our Sponsor

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The UT PEMBA is the longest-running, and most highly respected physician-only MBA in the country. It has over 700 graduates. And, the program only takes one year to complete. 

By joining the UT Physician Executive MBA, you will develop the business and management skills you need to find a career that you love. To find out more, contact Dr. Kate Atchley’s office at (865) 974-6526 or go to nonclinicalphysicians.com/physicianmba.


Land a Fantastic First Pharma Job in Clinical Development

Pharma is a huge industry, with thousands of physicians working in dozens of job categories. Some of these jobs can be filled by physicians with almost any background and experience if certain strategies are implemented.

Make yourself special on your resumé and make sure you stand out from the pack. – Dr. Marsha Caton

Today we get the perspective of a Ph.D. who has worked in several companies, at different levels. She applies what she has learned to help physicians find their first pharma job in Clinical Development. This is a very challenging but rewarding field to break into. As she points out, however, it can be done with proper planning, networking, and adjustments to your resumé.

Summary

Dr. Caton shared lots of information and useful advice in this interview. If you’re interested in breaking into the Clinical Development division of a pharmaceutical company to land your first pharma job, you will find it invaluable. 

NOTE: Look below for a transcript of today's episode.


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Transcription PNC Podcast Episode 209

Use These Simple Tactics to Land a Fantastic First Pharma Job

Interview with Dr. Marsha Caton

John: Well, I have been desperately looking to find someone who's an expert on careers in the pharmaceutical industry. I've had a couple of guests on, but pharmaceutical companies are so huge. They have so many types of jobs, particularly for physicians that we talk about. I was really happy to be able to meet on LinkedIn today's guest, Dr. Marsha Caton. She is a Ph.D. with experience in multiple jobs at multiple companies. And so, I really appreciate her for coming here today. Welcome to the podcast, Dr. Caton.

Dr. Marsha Caton: Thank you very much for having me. I'm very excited to be here and to talk about something that I love to do and love to see people succeed with.

John: I get questions asked all the time about how to break into a pharma job, particularly from those physicians who did maybe minimal research, had minimal exposure, didn't work in academia, and that sort of thing. So, I'll really be interested to hear what you have to say. But just to help our listeners understand where you're coming from, why don't you tell us a little bit about your educational background and your career so far in terms of what you've done in pharma and elsewhere?

Dr. Marsha Caton: Thank you for that. I have a Ph.D. in human molecular genetics. I went to Albert Einstein College of medicine. And after completing my Ph.D. really decided that I wanted something a little bit different from bench research, which I'm sure a lot of physicians can somewhat identify with. With getting to the end of the road and saying, "Hmm, I wonder if I would like to try something a little different". Most PhDs do go into bench research. I think now it's becoming a little more acceptable to not go into a postdoctoral program and onto running your own lab and research center of some sort.

But at the time I was pretty much an outlier and decided that I was going to chart a different course. That course really wasn't very apparent to me because nobody really talked about what you can do outside of becoming a tenure track professor, but with some research and a little bit of persistence in the job market, I was able to break into pharma.

My first role was in medical affairs. And then I had gone into, benefit risk management, into pharmacovigilance or safety reporting and then finally into medical writing. So, those are the different roles that I have held, each having a little bit of a different emphasis, but I wouldn't have it any other way.

John: Now with that experience in addition, you do a little bit of mentoring coaching from what I understand. Maybe you can tell us a little bit about that.

Dr. Marsha Caton: Absolutely. That has been something that sort of found me. I was there on LinkedIn, minding my own business, and a lot of people, PhDs and MDs would reach out to me to find out more about what I did in the industry. How I broke in was the most frequently asked question. How did you get in? Because I've been applying for two or three years, and I have no idea why I'm not getting any responses. I don't know what I'm doing wrong. I've tried all the companies, all the biotech's, all the CROs, is usually what I hear and still nothing.

Initially this started off as me just having conversations with people who I had never met, who just wanted a little bit of help. And so, I began to help those people as much as I could. And then they started sending their colleagues to me. And so, that's how my consulting opportunities really found me as I said.

John: Well, I think it shows that there's probably a huge demand for helping people with this problem. Particularly I have three groups of physicians that tend to ask me questions and that follow the podcast and other things. It's usually someone who's been out in practice for 5 or 10 years who is either burned out or they're just getting tired of clinical practice, and wants to try something different.

Then there's those that contact me that don't have residency training. They may have an MDD or maybe an MBBS or equivalent. And for whatever reason, either they couldn't get a residency or they just chose not to do it. And then occasionally I even had this question. I had a resident ask me the other day thinking "I don't think I want to practice when I get done, but I would love to go do some research in a pharmaceutical company". And he was a psychiatrist, I think. Having said all of that, I'm going to let you kind of talk about what kind of jobs would each of those groups tend to be most likely to transition to in your opinion.

Dr. Marsha Caton: I've had all of the above reach out to me. And I usually start out by getting the conversation about what's really important to you. And most often I hear, "Well, the quality of life and not spending 80 hours a week in the clinic" and that sort of thing. And then from there, we move on to what kind of role do you see yourself in? And most people are really not aware of the types of roles that are in pharma for physicians and scientists or physician-scientists. And there are several.

I don't think there's really a limit, but I think you tend to see a concentration in a few roles. So, there's the clinical director role. And that role is really involved in driving the execution of the study, looking at the science interfacing with the clinical sites. The PIs at the clinical sites, I would say. And really driving the clinical development program forward for a particular compound and indication. You might have whatever indication there is, vaccines or oncology. And a clinical director might have a portfolio that he or she is responsible for, making sure the execution is there for those particular compounds or drugs.

And then there is the medical monitor who really looks at the safety aspects of the study. There is also the pharmacovigilance or the safety physician, which looks at the safety of the program. So, a bit higher level than the medical monitor. The medical monitor is involved in the day-to-day communication with the sites about adverse effects that are being observed and keeping a pulse on the safety of the compound. Whereas the pharmacovigilance department or physician is really overseeing and sometimes looking at signals and the overall safety profile for the drug.

And then there are a fair number of physicians who are involved in regulatory sciences. And so, they are really invested in knowing the industry regulations, whether it be the FDA or the EMA or Health Canada, or PMDA in Japan. They are really abreast of the regulations. And so, it's where the science meets the clinical meets the regulatory.

Those are some of the major buckets, but there are roles across the organization that physicians, scientists, or physician-scientists can find a home in. And there's also medical affairs, which is another huge realm for physicians as well. And they are really involved in the commercialization aspect, not sales, but commercialization in terms of making sure the clinical information is disseminated to the sites and the advocacy groups. And it gets out into the marketplace. They are really involved in the education and making sure that the clinical information for the drug is well-positioned in the marketplace.

John: There's a lot of options there, aren't there? And we could dig into each one, but I'll avoid that for the moment. Let me ask you the question from this perspective. Let's talk about the clinicians that may be in practice. Now, I think it's one thing for maybe an oncologist who maybe has been involved in studies as a side over the years. It would seem that person would probably have an easier time converting to something in clinical development than let's say someone who's just been practicing privately and not been involved in any studies.

But is there a background that a physician, a practicing physician, whether an internist or ER doc or whatever that you could think of that would enable them to get into either the clinical development or maybe some other aspect? And I'm thinking of things like, I mean, we had an IRB, we had people that were on that IRB for years, and they really understood looking at studies, at least. They had that. Or maybe they did research in undergrad or at a master's level for something even before they went to med school. What do you think about those scenarios?

Dr. Marsha Caton: Right. I think those are all helpful in getting yourself noticed in the candidate pool because the pool is huge, right? There are people from all over the world who are applying for these roles sometimes. For someone who's in internal medicine or so, if they've written any textbook chapters, if they had any exposure to clinical research in the past, whether it be from taking a good clinical practice course or understanding say international codes for harmonization.

Various things. There are ways that people can get exposure to the world of clinical research. If there is no prior clinical research, I usually strongly encourage people to look into small certificates that at least begin to demonstrate that you have some familiarity with the field.

And some of these are not extensive. Some of these can be free. There is a whole list of organizations and places where you can go to get some kind of certification. And most times we're talking three to six months in time investment just to get your feet wet into the world of clinical research.

As you and I chatted about before, medical writing is a great way for physicians to get into clinical research and into pharma because it really exposes them to the full gamut of the deliverables. The deliverables being the end products of all of this research. So, you have this compound and you have a program to test it in a particular subset of patients, and you do all of that. And that culminates in several deliverables that are submitted to the agency, and that's where regulatory medical writing comes in. And so, I have had a few physicians. I can think of one who had a little more exposure and one who really had very little exposure to clinical research. And so, I connected them with someone in my network to get exposure to medical writing. And they both eventually landed industry jobs, using that method.

John: Okay. Can you tell me more about that? Medical writing when we look at it, we've had guests talk about that. It goes everything from journalistic writing for the public to CME and education for the public to other things. But we often also hear about this regulatory technical side and I even had a guest once who was doing freelance medical writing and moral journalism, and then she ended up being hired by a CRO to do more technical work. So, tell us a little bit more about the kind of writing we might look to do and how to get into that writing as a way to step into pharma since we're talking about it.

Dr. Marsha Caton: Sure, absolutely. So, my area of expertise is not the journalistic, CME, that sort of thing writing. I am really specifically in regulatory writing. And so, regulatory writing is very different from the writing that you would do for medical affairs, where you're writing a publication or CME materials, slide decks, that sort of thing, posters, abstracts. Very, very different.

Regulatory writing is really a highly regulated environment that really follows very specific guidelines laid down by the FDA, and other foreign regulators that really prescribe how data needs to be presented. There are rules that ensure the robustness of the data, that ensure the safety and efficacy are there. And so, there are oodles and oodles for lack of a better word, lots of, lots of regulations about how these data is to be presented. And so, regulatory writing is really focused on making sure you present your data within the framework that is prescribed by these regulatory agencies, by the FDA or the EMA.

And so, it's its own skill. It's really high science. There is a lot of clinical input that goes into that. But what is required for that is really a strong understanding of the science and an understanding of the regulations, and framing that in a clinical context. So, it's a very interesting intersection in the pharmaceutical industry, but it's one that is in high demand. And it's an area of increasing importance as the regulations get more and more stringent for demonstrating relevance in the industry for the irrelevance of your data, right? It's one that's becoming of increasing importance because understanding the regulations and what the FDA or EMA would like to see, and then how you position that, understanding the science and understanding the competitive landscape, what are your competitor products and how do you compare against those? That's one segment of what one needs to understand. And the other segment is the mechanism of action of the drug and what you see in the patient is really connected to the mechanism of action. Everything is not cut and dry. So, the science becomes a big interplay there with the clinical.

John: How might one get some experience or start to understand the regulations? Some of us are exposed to it, of course in our practice, some of us, like I said, if we're working and doing a study maybe as a site for a larger study or even an IRB, we're looking at studies. Some of us may have had the opportunity to write articles, be an author for some clinical study, not a pharmaceutical drug study or something like that, a phase three or something, but actually just some research. And so, how would we try to pull that together?

Dr. Marsha Caton: Well, first of all, there are international guidelines that govern regulatory writing. In the industry, we refer to them as ICH guidelines, which stands for the International Council for Harmonization. And that is based on lots and lots of conglomerate ideas about the way documents are written should be consistent regardless of the region of the world that you're submitting to. So those are the basic set of guidelines. And then you can layer on top of that FDA guidelines and then and or EMA guidelines. That's where the familiarity comes, and looking at those regulations and really having a thorough understanding of them.

If I had to say the easiest way to get some experience. "Easy" is relative here, but the easiest way to get some experience with regulatory writing would probably be through looking at CROs. Just because with big pharma is usually a requirement for prior experience doing that. For the couple of physicians that I steer towards medical writing like I said, I connected them within my network, with the contacts who had freelance regulatory writing businesses. And so, that's a much lower bar than even getting hired at a CRO or getting hired at a pharma company, which is I wouldn't say impossible but challenging. That is the route that I have taken with some of my clients.

John: Well, that makes perfect sense. We've seen this in other fields, I don't know, UM and other things. There are firms like a CRO, that's a middleman and they will hire their own doing this thing, but then they'll also do freelancers and temporary and so forth. So, the CRO, I think, from what you're saying, hire sometimes to fill in those gaps or freelance writers to do the regulatory work. So that, like you said, might be the lowest bar for someone looking to make that switch. And believe me, it's not quick. I have people that are saying, "Well, should I take three years and get an MBA to change my career?" Some of them are pretty, not desperate, but they're willing to do almost anything to move out of clinical medicine sometimes.

Dr. Marsha Caton: One of the women physicians that I've worked with, she was in the process of doing her MBA, and actually ended up landing a job while she was doing the MBA. So, I would say the MBA is not absolutely necessary. You can't go wrong with an MBA, don't get me wrong. Regardless of whether you use it when you're starting or whether it's down the road, I think the value of that, everybody knows the value of the MBA.

But in terms of the industry, I would say that it is not absolutely necessary unless you really want to end up in the business side, leading a business or a franchise. I would say you could probably forego that if you amassed the right kind of experience with clinical research. But that really takes knowing where to go, knowing who to talk to, and being exposed in the right context.

I've seen courses out there and I've looked at the courses and there are courses, say for medical writing even. It's like, well, it could be made out to be more than it really is in some instances when you look at the courses because I'm sure your audience can identify the way to learn to do surgery is not to read about doing surgery. It's to do surgery. It's to pick up the scalpel and do the thing. It's not to sit and read 29 textbooks about what to do.

And so, sometimes you have courses that may say, "I can teach you all about it", but you're not actually doing the thing in real-time. And so, it's really about getting the right kind of experience that communicates to potential employers. That, "Hey, yes, I actually have exposure to this. I actually understand what the different documents are. I understand what the clinical summary of safety is. I understand what a clinical summary of efficacy is. And these are the things that you have to provide to these agencies, summaries of the efficacy of your drug, summaries of safety, and what the studies look like and demonstrating when you sit in front of an employer, that you understand what clinical research is all about". Really no bias.

And I say that, honestly, it's not because I am in regulatory writing, but if you really want to understand what pharma is all about and to begin to develop expertise, there is actually no better way than to be involved with the documents, hands down. It's the equivalent of just being able to see a patient. You can sit at home and read and read and read, but until you see a patient, you're not seeing patients.

And so, in pharma, there are no patients that the employees deal with. You have these documents, that's the embodiment of your research. And so, there's no better way to get that expertise than to really get your hands on these documents, to look at them, to read them, to ask questions about them, to listen to the content being discussed. And all of that is a part of what you get in medical writing.

John: That's very helpful. Well, I'm going to come back to my listener. He has time. He's not quite finished his third year of a four-year residency in psychiatry, and he might be able to get some more exposure. Now he's involved with some clinical studies. These are really more comparing different, let's say, plans of care, which is the best. It's not really involving drugs or pharmaceuticals or medical devices. Are there other types of research that one would be involved with which would be a little more applicable or be more likely to help someone convince that hiring manager or whoever looks at these resumes to pick that up?

Dr. Marsha Caton: Absolutely. When you say clinical research, I could see the effect if this person goes for an interview. Like, "Oh, I've been involved in clinical research". And you're like, "Oh, what types of?" Yeah, not quite. So, it really has to be very relevant. And so, for someone like that, who's just starting, I would say perhaps the best thing to do would be to look, identify clinical sites, and either volunteer time or become a sub-PI or something like that.

One of my first industry gigs was in a research center in the hospital. That was my very first introduction to clinical research. It was just an oncologist. He had a team, he participated in studies with some of the major pharmaceutical companies. And so, he was the PI and he had a whole team around him. And so, that's a great way to get relevant experience in clinical research. Just identify centers in your area, they're all over the country. And so, it can be something as small, and if you're clinical, there are lots of ways that you can volunteer your time. If that's a path that you're really keen on following.

John: I do think that he would probably be able to find some opportunities if he really looked around. I think he's in a pretty big academic center and should be able to find things. It might not pertain directly to his residency, but that's okay. From what I understand, psych residents have a little more time than let's say the surgical resident would have.

Dr. Marsha Caton: Oh, this will be for the benefit of your audience. If you go on clinical trials.gov that'll show you every clinical trial in America. You put in your zip code and you can identify clinical trials in your area quite readily. And it usually has the PI information, name, institution, most times. Sometimes even an email.

But if you have a name, if you have the name of the institution, it's easy to track somebody down from there and say, "Hey, I am so-and-so. And I'm very interested in learning about clinical research and I can come and administer informed consent if I'm well-trained". Very easy tasks that can be done. Informed consents are written on I think, sixth grade or eighth grade level. So, it doesn't take a highly skilled person to do that, but it's a great way for you to find an area for entry into that clinic or into that space.

Just look for ways to volunteer and help. There are sometimes people in those centers who are looking for sub-investigators, and that's also another way to get some experience. There are also now more recently, fellowships to train people to participate in clinical research. Quite a few for underrepresented groups, where they're trying to encourage physicians to get involved in clinical research in underrepresented groups.

Those are all great opportunities to get some insight into the world of clinical research and then all kinds of things. There are fellowships at the FDA and at the NIH. So, all kinds of ways if someone is willing to invest a year or so to get relevant experience, applying for a fellowship. I mean, of course, those are competitive, but people get in, so it's not impossible.

John: Someone's going to get that position. So, it might as well be you. All right, Marsha, this has been great. I try to make sure that if someone has a question or wants to follow up with you, I guess in general, they have a place to go to. So, I'm thinking we're going to go with the LinkedIn profile, which I'll put a link to. Of course, they can just look up your name, but I'll make it as easy as possible if they want to follow up. Any other advice for my listeners before I let you go?

Dr. Marsha Caton: Yes. In addition to getting the relevant experience, there is a definite threshold for making yourself most attractive to an employer, and you can only do that through a resumé unless you happen to know someone who can directly refer you. And even sometimes with direct referrals, it still goes to someone who looks at your resume and says, "Well, I don't know if this is great compared to all the other resumes that I have". And so, there is, there is a definite strategy in terms of positioning oneself. Once you've gotten that experience, making sure it's written up well and clearly displays the clinical research experience.

And there is a method to doing that, evaluating the job description and making sure that you're a good fit. Because I think some of the frustration comes when people apply for things for which they're not the best fit. Definitely, make sure your resume tells the story, it presents you in the best possible light and it highlights the relevant experience that the hiring manager is looking for.

John: And they can usually tell that hopefully from the job description, right? Sometimes we see a mismatch, but they should be able to, at least what's on paper, try to address.

Dr. Marsha Caton: Right. Now, it sounds simple, but I cannot tell you how many people send their resumes to me and I'm looking at them and I'm saying, "Well, I can understand why you haven't gotten any calls back. This resume that looks wonderful does not display how wonderful you are". And it's important for people to understand that pharma is a very, very high-achieving industry. I would say 70% of people in pharma have terminal degrees. So, walking down the street, I might be the only Ph.D. in the room, but when I sign into work, I am one of thousands. Same for the MD or the DVM. Almost everybody has one. So, you're not special in that regard. You have to make yourself special on your resume and make sure you stand out from the pack.

John: No, that's true of a lot of jobs too when you get to that level. I guess we could spend a whole other hour on resumes, but if you could boil it down to one, when looking at these resumes, just one thing, is it just that, that it doesn't stand out, but why does it not stand out? What is missing that really should have been there?

Dr. Marsha Caton: Usually it is the relevant experience jumping out at the employer as soon as you read it. People in pharma are incredibly busy and I interview people all the time. And by the time I've read halfway down the page, I kind of know whether this person has what it takes or not.

John: So, it should be front and center. It should be pretty much on the first page, the middle of the first page, whatever you want to call that, top of the first page. And it's like, okay, here's what the job entails. And you have this experience, which is somewhat transferrable or identically what we need, get that out there. And no 5- or 10-page resumes unless you're looking for some kind of an academic situation.

Dr. Marsha Caton: Correct. Nobody's reading 5 or 10 pages. For physicians, it's really important to identify transferable skills because in the clinical world, that's what people want to see. But in pharma, they want to know that you're a clinician who can handle the science and all of this hospital, that hospital, this clinic. Yes, we know, but that's not what this job is about. So, it's really important to now transform that experience, those experiences I would say, into something that's relevant for clinical research, whether it be writing, data analysis, lots of different things that need to be highlighted to transform that clinical resume into a pharmaceutical ready resume.

John: Very good. I thank you so much for sharing all of this with us. And if anyone's listening and you want to reach out with additional questions, I definitely will go to LinkedIn and look up Dr. Caton today and or down the road. And I guess with that, I will say that we're out of time. So, I'll let you go. Thanks for coming and it has been very insightful.

Dr. Marsha Caton: Thank you so much for having me.

John: All right. Bye-bye.

Dr. Marsha Caton: Bye-bye.

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