On Campus Podcast – Professional Development Series – Episode 2: Leveraging Regulatory Experience for Compliance Careers

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1. Introduction and Episode Context (00:00:06) Overview of the episode, guest introductions, and the focus on career transitions into compliance roles.
2. Transferring Skills to Compliance Roles (00:01:14) Discussion on how current skills and education can transfer to compliance positions.
3. Anne’s Background in Environmental Health and Safety (00:01:29) Anne shares her experience in environmental health and safety compliance across various industries.
4. Andra’s Background in Healthcare Compliance (00:02:21) Andra discusses her experience in healthcare compliance, billing, coding, and compliance program establishment.
5. Defining Environmental Health and Safety (00:02:50) Explanation of environmental health and safety, relevant regulations, and their impact.
6. Transferring Skills and Career Transition Advice (00:04:22) Advice on leveraging existing skills and interests for compliance roles in different industries.
7. Seven Elements of an Effective Compliance Program Introduction (00:06:32) Introduction to the seven elements of compliance programs and their cross-industry relevance.
8. Oversight and Leadership in Compliance (00:09:24) Importance of independence, reporting structure, and authority in compliance roles.
9. Training and Education in Compliance (00:12:09) Role of training and education, instructional design, and making compliance education effective.
10. Auditing, Monitoring, and Risk Assessment (00:13:29) Auditing, data analysis, risk assessment, and the value of technical and analytical skills.
11. Effective Lines of Communication (00:15:55) Importance of multiple reporting channels, confidentiality, and communication in compliance.
12. Enforcement of Standards (00:17:23) Enforcement, accountability, and maintaining neutrality in compliance investigations.
13. Responding to Detected Offenses and Corrective Action (00:18:38) Prompt response to violations, corrective actions, and the importance of reporting structure.
14. Overlapping Industries and Transferable Skills (00:19:20) Opportunities in overlapping industries and the importance of people skills in compliance.
15. Pharmaceutical Manufacturing Compliance Opportunities (00:20:25) Growth in pharmaceutical manufacturing and compliance opportunities for professionals.
16. Conveying Transferable Skills in Job Applications (00:21:23) How to communicate transferable compliance skills in resumes and interviews.
17. Building Skills and Networking through Filler Jobs (00:22:46) Using interim jobs to build skills, expand networks, and enhance resumes.
18. Advanced Technology and Automation in Compliance (00:23:23) Impact of AI and automation on compliance roles and the need for human oversight.
19. Relevant Courses and Continuous Learning (00:24:14) Recommended courses and continuous learning strategies for compliance professionals.
20. Conclusion and Resources (00:25:33) Closing remarks, invitation to explore further resources, and acknowledgments.

Ed Butch: Welcome to On Campus with CITI Program, the podcast where we explore the complexities of the campus experience with higher education experts and researchers. I’m your host, Ed Butch, and I’m thrilled to have you with us today. Before we get started, I want to quickly note that this podcast is for educational purposes only and is not designed to provide legal advice or guidance. In addition, the views expressed in this podcast are solely those of our guests.

Welcome to On Campus with CITI Program. I’m joined today by my colleagues and guest hosts, Anne Hawkinsbadge and Andra Popa. This is a follow-up to Julie Hamilton’s podcast. As you all recall, she’s the owner and CEO of Core Rising, which she created in 2021 to help individuals and leaders identify their core values, skills, and talents acquired from their workplace environments, and align their lives in ways that bring joy and inner peace to their work and home lives. If an individual is thinking about and planning a career transition, it is critical to identify and market how one’s current skills and education can be transferred to another career. In this podcast, my colleagues, Andra and Anne, who have obtained experience working with regulatory requirements, will discuss how the skills they have acquired may transfer to a compliance position. And on that note, welcome to the podcast, Andra and Anne.

Anne Hawkinsbadge: Hi. My name is Anne Hawkinsbadge. I’m here because I believe compliance is a critical part of my particular profession. I have worked in multiple academic settings, manufacturing automotive, manufacturing chemical, manufacturing pharmaceutical, workers’ compensation insurance, and the field of environmental health and safety. I’ve served as a responsible official. I’ve added to my experience, my educational background in environmental health and safety with a Master’s and a Doctorate in Health Science, and I carry the Certified Safety Professional Certification, one of my certifications. So how does that compare to your experience in healthcare?

Andra Popa: Healthcare compliance can be highly specialized, so people can be generalists. When I had a consulting practice, I tried to learn as many specialties as possible with a focus on Medicare compliance. I started with billing and coding for an anesthesia practice, which was my father’s, in high school. Medicare coverage analysis combined my interest in medicine with my knowledge of billing and coding as well as my training in law school. I also established compliance programs in healthcare entities. Could you explain to us what environmental health and safety means?

Anne Hawkinsbadge: We call it environmental health and safety because those are the primary, what we call regulations. We deal with the APA environment. We deal with OSHA, which is Occupational Health and Safety. OSHA has multiple branches. Environment usually is what is the impact on human life or health, and what is the impact on the community? We look at the confines of the manufacturing building or plot that the building sits on. We look at how is it going to get downstream. And the safety aspect of it, I think in terms of it more as being a physical, in other words, when you go out a door for an exit, is the doorway blocked? Is your fire doorway blocked in terms of that guarding? Those type of physical things.

Or is health, what is going to impact the inside of your body and your systemic? Yes, safety can also mean slips, trips, and falls, and cuts, and bruises and so on, so forth, and those are of short term. But the health aspect is the long term. This is going to be like the exposure to asbestos or it could be like in pharmaceuticals. It could be dealing with your anthrax. Now, that could very easily jump down into biosafety, which is dealing more specifically with biological organisms.

Andra Popa: If you take the skills that you currently have at a compliance profession role where, perhaps, the industry is unstable, how would you do that?

Anne Hawkinsbadge: Write your skills that you believe you have and you’ve learned, and then listen to your inside. What area in your life would you like to expand upon? If you’re into food, you’re a foodie and you want to get involved with it, then you can work with the compliance into the food industry, whether it be manufacturing or the actual serving of food. And don’t forget about any volunteering you’ve done. Anyone that maybe for example, has stepped away from the work world to raise their children and want to come back, think of everything you’ve been involved with your children. If your heart says, “No, I’m really into research,” then you take those skills and you put them into research. Take what you’ve learned and then listen to what your heart says, where your interest is and combine those two.

If you get into a manufacturing position and you are on the floor making parts, there’s a part of compliance that’s there, whether it’s viewed as quality or whether it’s viewed as EHS regulatory, or maybe in environmental, EAR, [inaudible 00:05:48] and the concept of compliance, so take those skills. And the more experience you have, whether it’s on the floor, developing something, improving… Look at the processes, the processes are part of compliance, all that’s critical. If you’re heavily involved with robotics of the floor, there’s tremendous amount of regulation with it and tremendous opportunity to learn.

Andra, why don’t we take our audience through the seven elements of an effective compliance program, and if you would be kind enough to start with the first element and tell how it applies to healthcare? Then I can follow up with environmental health and safety, and we can go through them that way.

Andra Popa: These elements originated in the U.S. Sentencing Guidelines. They don’t apply to one industry only. The first element we’ll discuss is policy and procedure development. This element, the main skill is not necessarily writing skills. It’s rather gathering people together and getting a consensus as to what the policies and procedures are within the framework of rules and the mission of the entity. If you have some experience gathering a consensus, tracking document, this is a great experience for this pillar. Policy includes state and federal requirements. They could be professional or they could be codified within regulations or laws. And then your procedures are how you operationalize the policies. I like to keep policies and procedures to one to two pages. And at the bottom there should be information about when they were changed and why. Very brief summaries with the date and explanation of what was changed and why, as well as there could be citations. This is universal, correct?

Anne Hawkinsbadge: Yes. Let me jump in here. We follow environmental health and safety, very similar. The policy is often viewed as a very high level and doesn’t call out any particular individual or job description. It just gives an overall what needs to be accomplished. The procedure gets down into the more precise pathways and processes in order to accomplish the needs of the policy. And then sometimes, like for example in the manufacturing on the manufacturing floors, we break the procedure down into we call work tents, which specifically tells that person how to operate a piece of equipment or how to perform maintenance, and some of this becomes out as maintenance procedures.

We also believe in version control, also keeping records of when the procedure was updated. Hopefully people can see that this whole concept of policies and procedures flow nicely across the compliance you are doing and the compliance environmental health and safety is doing.

Andra Popa: You’re process mapping the workflow, possibly improving the workflow.

Anne Hawkinsbadge: Their work as you’ve described, identifies and understanding regulations, regulatory variances, anticipating potential hazards, implementing control measures to eliminate or reduce the risk, auditing compliance, training, developing management systems, processes, et cetera. And I think you hit on a very key point about pulling everyone together that are the key stakeholders to really make the effective procedures policies.

Andra Popa: You could look for jobs within manufacturing or healthcare compliance that are related to another element which is oversight and leadership. It’s really important that this person be independent and the government in healthcare such as the Office of Inspector General will look at that. So they shouldn’t be reporting to someone in operations because they’re technically auditing and evaluating that department. They shouldn’t get their paycheck signed, so to speak, by someone they have authority to audit or to evaluate in terms of their compliance. Some compliance roles are generalist roles and ideally they have an independent board that assess risk. Is it the same in manufacturing?

Anne Hawkinsbadge: Environmental health and safety takes the same approach because of the fact that we should not be reporting to facilities because environmental health and safety regulations impact facilities. We could create the auditing tools that have to be used within facilities. Environmental health and safety needs to have a reporting structure that isn’t embedded in mid-area of the organization, but needs to report to the top. And from my experience, one of the best ones we had were we reported to a VP of EHS or we reported into legal.

Andra Popa: So we’re both saying that the compliance positions, compliance officer should have a high level of authority and then independence is key. So people that are looking to transition their careers into a compliance field in manufacturing or healthcare should look for those attributes in job descriptions.

Anne Hawkinsbadge: Very much, and I think that’s a very key point you made is that when you are looking at a job description for compliance professional or if you’re going to target one any particular area, healthcare, environmental health and safety or even quality, look where this position reports. Are you going to have the support you need in order to do the job that you’ve been hired to do?

Andra Popa: And in my experience, it’s not only interpersonal or auditing independence. The line of reporting is extremely important in creating policies and procedures because if you report within operations, they might have the authority to change the policies and procedures where your compliance reports do not go out of their department. The third element of an effective compliance program is training and education.

Anne Hawkinsbadge: Whether that be for the employees, the visitors, the patients, the students, whoever comes into that organization I think is critical. If the systems are incorrect, the policies are incorrect, education is just going to continue to teach the systems and the policies. So that would be one of the things that I would say, that, and I think you agree, you have to make sure education has the right value.

Andra Popa: For example, education is less about being pedantic, but more about understanding how to make education memorable and relevant to somebody’s role. The design, the colors, the font that you’re using as well as the medium make a big difference in education.

Anne Hawkinsbadge: I think that’s a really good point about the arts and the instructional design. We don’t want death by PowerPoint anymore, but we make it interactive. Your audience will always have a wide range of ages and skills and it just takes one little thing, one little unique nuance to make that stick for somebody. So the areas that you come in with your different experience, that art and instructional design, look at education for compliance.

Andra Popa: In the fields of manufacturing, another element is auditing, monitoring, and sometimes the area of risk assessment is combined. This area is suited for someone with a background in statistics, computer science, data analysis, programming, as well as a legal background. Compliance is not only identifying and understanding the laws and regulations that apply, but it’s also data analytics, especially now that government is using data analysis to find fraud in the healthcare profession. A background in any of these areas, particularly computer science, data analysis, programming, understanding, and building databases for example in SQL would be invaluable for a compliance team.

Anne Hawkinsbadge: I would say very much, especially IT, have learned to look at systems, learned to anticipate where problems may be. Those are all skills that can be applied to auditing and can be applied to the risk assessment. That’s a really good point that you brought up.

Andra Popa: If you have experienced teaching large language models, that would be very effective in helping a compliance program do their work. What you would do is program the model to learn keywords that might hint at an audit risk, compliance risks. Risk assessment might be interesting to someone with a military background or law enforcement where risk is approached in a logical way and you don’t necessarily have to go to law school. You must have risk assessment in manufacturing. Right?

Anne Hawkinsbadge: Absolutely, we have risk assessment in manufacturing. And I think the description you gave was excellent. So risk assessment can be, say a physical assessment and it can also be a paper assessment, like what you were saying about the financial aspects of it, but the risk assessment, I’ll call physical will look at things that could cause an incident. It could be electrical, it could be anything like that, and you look at maybe new purchases of property. What are the risks brings into you? Again, this is all part of the skill set.

Andra Popa: In addition to, there might be some people in accounting that are displaced because of AI, so risk assessment would also include outside vendors. Another element of an effective compliance program is effective lines of communication, so this, people think of compliance hotlines. It just means you have a variety of ways for employees to report concerns or suspected violations. There should be options to report confidentially and there should be a process to address the concerns and begin an investigation.

Anne Hawkinsbadge: That’s really critical, and I think the thing here is that it’s not just hotlines. It’s every time you have an interaction with an individual, they could potentially report something to you and then how do you handle that? To education and training, we learn a lot of things that are not right. We learn when we do our policies, a lot of things that aren’t right. The procedures don’t truly reflect the actual work that’s going on, so therefore that leads to potential errors.

Andra Popa: A person should never change the procedures they’re doing without first getting approval and having everything in writing within the policy and procedure. First, someone writes the procedure and then it goes out to the people who do the job for them to review it.

Anne Hawkinsbadge: I like this process because of the fact is they don’t have the time to write it, but they do have the time to edit it and provide input. That’s why your personal communication and your trust is critical with the people who you’re working with.

Andra Popa: In addition to communication. Another element of an effective compliance program is enforcement of standards. Enforcement is about trying to reward good behavior, trying to treat people even at the highest levels with the same accountability as you would throughout the levels of an entity.

Anne Hawkinsbadge: I’m really glad you explained about enforcement. I think so much in the environmental health and safety perspective we’re viewed as the police officers there to correct someone who’s doing something wrong. I also believe that many professionals in the EHS role like biosafety, radiation safety officers don’t see themselves as compliant professionals. I try to neutralize myself from any enforcement but look at the systems and do a report, a very neutral report on what happened or didn’t happen. Then it’s up to the supervisor, manager, HR to take it from there, but again, make sure what I’m saying is correct. I make sure that doesn’t destroy the trust and I make sure that, again, everything is…

Andra Popa: The final element of an effective compliance program is responding promptly to detected offenses and undertaking corrective action, investigate reported issues quickly, take remedial steps to correct problems and prevent recurrence, including self-reporting to authorities when appropriate.

Anne Hawkinsbadge: You may have an OSHA or myOSHA, I’m from Michigan, so hence myOSHA follow up. This is where one year our involved with environmental health and safety compliance as your reporting structure is so important because there may be a point in time when you have to ask for attorney-client privilege because of the depth and breadth of this investigation.

Andra Popa: Job seekers can select overlapping industries. For example, it could be manufacturing within the healthcare realm or compliance with different safety issues related to healthcare such as radiation safety.

Anne Hawkinsbadge: I think the key thing that we have to always keep in mind is that when you’re in a world of compliance, you’re going to meet resistance that people don’t want to change or don’t think the rules apply to them, and this is where your people skills, which is very important come into play. If you’re not necessarily a people person, the support you bring through the technical is still definitely needed in compliance. We have to submit our information in such a way that upper management, mid-level and up understand it, and many do not have courses or background in compliance and may tend to put that information to one side all for the concept of moving production forward.

Andra Popa: I’ve read that several pharmaceutical companies are investing billions to build U.S. manufacturing plants with new facilities. I was wondering what you thought about this given your background in pharmaceutical manufacturing compliance. Are these compliance role opportunities for people?

Anne Hawkinsbadge: Very much, and I would say that once the pharmaceutical manufacturing is built, it’s excellent for them, but I would also say it’s their skills that they learned in HHS could be applied at the design stage of the facility for pharmaceuticals. Architects may not have the necessarily knowledge of containment or how to clean in place or as individuals that have been heavily involved in the pharmaceutical arena from a regulatory point of view will understand that, and the same thing is true of people who’ve actually done the work in pharmaceutical. This is another great area that they could lend their expertise to designing the building correctly so it can get the manufacturing up to speed quicker.

They have to be able to, during the interview process or in their resume, completely convey to their potential employer how these skills transfer. You need to be able to say, “These skills that I’ve identified in my past experience that are associated with compliance, this is how it’s transferred to this position.” You have to be able to make that conversion for the people you’re interviewing with. You have to do that even before the interview. Don’t think you have to go back and get a degree at this point in time. Get good information from reliable sources and make sure that perhaps has a Certificate of Completion with it so you can back up what you’re saying to your interview or during your interview and put together a small portfolio if you are interviewed so that you can take it and physically show them that you’ve completed these courses.

Andra Popa: You can also research a new area, write about it and publish to establish yourself in a different sector.

Anne Hawkinsbadge: Agreed, and I think the other thing that we should say here too, if for some reason you have to take a filler job while you’re looking for the job that your heart says is right, use the experience from that filler job to continue to add to your resume your skills. Don’t look at that job as just a paycheck. It’s also an opportunity to expand your network and identify people that might be able to put you in contact with someone associated with your ideal job.

Andra Popa: A big piece of this seems to be not only having transferable skills, building the skill set, but also understanding how advanced technology such as AI can automate parts of your work. There have been reductions in staff, so you need to be more efficient with your time. Could you explain in a practical way how advanced technology could be used in the manufacturing sector?

Anne Hawkinsbadge: Right now it’s starting on the outside and working in, so it needs to build, the AI tool needs to be built and tested for the particular industry. For example, AI would be excellent in generating, let’s say, for example, auditing, auditing reports and maybe summarizing the results of those reports, but it’s still going to take a human to interpret and ensure that those reports were done correctly.

Andra Popa: In the areas of pharmaceutical manufacturing, that has been automated for a very long time, but you still need humans in a lot of the aspects of that. You discussed Certificates of Completion to bolster a resume or to make a transition in a career. What are some of the examples of CITI courses that relate to your area of expertise?

Anne Hawkinsbadge: I would look at any course that CITI has that’s the IACET. I-A-C-E-T.

Andra Popa: If someone wanted to broaden their knowledge base of healthcare compliance, if they’re looking to get into healthcare compliance, a good place to start would be the Federal Fraud Waste and Abuse course. Also, review the World of Medicare course, which is foundational and one of the largest areas of risk for fraud. It gives a very good understanding of the way that Medicare is structured. Another course you want to look at is the False Claims Act for Research. Also, you can just spend a few minutes a day learning about healthcare compliance or general compliance. Try for 15 minutes or half an hour at lunch or in the morning. Keep up with our webinars. We have free webinars that explain the structure of a compliance program and how the seven elements have been used by different compliance officers and experts. Thanks for this valuable discussion, Anne.

Ed Butch: I invite all of our listeners to visit citiprogram.org to learn more about our courses and webinars on research ethics, compliance, and higher education. I look forward to bringing you more expert guests to discuss what’s happening on campus. Special thanks to our line producer, Evelyn Fornell, production and distribution support provided by Raymond Longaray and Megan Stuart.