BCMAS graduates come from a diverse background with diverse experiences. It’s great to hear about our graduates’ roles and how they’re navigating their medical affairs careers. Dr. Jaideep Banerjee, PhD, BCMAS has the unique experience of becoming a medical science liaison team leader that supports devices, pharmaceuticals and biologics, which are all regulated differently. He discusses how he manages the regulatory challenges, especially now during a global pandemic.

What is your current role? 

I am the senior manager of the Medical Science Liaison team and the senior manager role is the team lead for the MSLs. I also look after the clinical strategy for tissue & biologics products.

How do you incorporate clinical strategy into your strategy as an MSL team leader?

The MSL role has two parts. One is evidence communication – the data, the clinical data, the science part – taking it out to the outside world and to the field. But then the other part of an MSL role is bringing information from outside to inside. Feedback, insight collection – that ties into clinical strategy because once you’re able to get insight, you then identify gaps in clinical knowledge.

You can identify these as places where we need some more randomized trials or maybe we need some more case studies. That then becomes your clinical strategy if you’re trying to expand the market, expand market access, trying to launch something in a different geography. All of those are a different indication. All of those are a part of clinical strategy that starts with the information you capture as an MSL in the field. Both of these are part of the MSL role, but these are the two halves of the same MSL role.

You support devices, pharmaceutical products, and biologics. Could you talk about how the team supports those different product types and implement the correct strategy while remaining compliant?

It’s just how the FDA regulates them. And I think this pertains more to off-label information. It’s about the interaction between the sales, the medical science liaison team, and the HCPs. In the pharmaceutical world, it’s much more regulated. The sales team can’t be in the same room where an MSL is talking to a doctor, especially if they’re talking off-label. If they’re talking on-label, yes. If they’re talking off-label, at the most, the sales can introduce you to the doctor and then has to leave the room or just not be in the conversation at all. For pharmaceuticals, it typically needs to be in a hospital setting or office setting. Dinner presentations are difficult to do. Devices are kind of similar.

Tissue samples have a little more leeway. There are a lot of off-label conversations that happen in the tissue space. But again, you are allowed to do some dinner presentations. You are allowed to do presentations or conversations outside the office setting. Again, the general consensus is that the sales will definitely not be involved in the conversation. In certain places, they can still be in the room but they’re just not allowed to be part of any conversation. But in general, it’s mostly about where you can have a meeting, who pays for a meal, or things like that. That’s where the differences are for pharmaceuticals, devices and tissue. I think the overall concept is that it’s a separate conversation from commercial. They need to step out of the room for any off-label conversation, just putting them aside basically.

How important would you rate the knowledge of regulatory and compliance rules is for MSLs?

It is very important because you need to know what the PhRMA guidelines are. It’s more important because the guidelines are not that specific. It’s more specific for pharmaceuticals and devices but not that specific for tissue. So you need to be more on the conservative side so someone can’t blame you for doing it incorrectly. For that, the MSLs need to know what the regulations are and how the field is regulated.

I can give you an example. There are a lot of slide decks that we present. If it is a speaker deck or promotional deck, that goes through the entire company promotional review committee. For the MSL slide decks, the MSLs have a little bit of leeway.

They’re talking about something that is unbranded. It’s important for the MSL to be responsible and to be aware of what you can and can’t say. A lot of it is self-regulating. If you are not aware of the rules, then you can get the company in trouble. So that why it’s very important to be aware of the regulations and you’re very responsible, and slightly on the conservative side trying to not make mistakes.

We are the ones doing all of these promotional reviews for the company as MSLs. So unless we are confident that we know the rules, how can we be the monitors? That’s why it’s important that we’re aware of the rules.

MSL activities this year have been very different due to the pandemic. What are some tips or best practices that you’ve used as a medical science liaison team leader to make sure that liaisons’ interactions are still valuable to the stakeholders and to the company?

That’s an interesting question. I think to the stakeholders, the one-on-one meetings, this virtual platform has an advantage. You can save on travel time and you can just do those face-to-face meetings. I strongly encourage being on the video, even if the other person or HCP isn’t on video. I think showing your face has a value to it.

One thing I suggest or realized is that it’s very important to turn on the video even if the HCP is not on video. The reason is, in our role, we’re trying to make an impression, even though we’re not in sales. We’re still trying to convey a message. Considering that HCPs are busy people, you’re trying to make an impression in the first five minutes, 10 minutes, 15 minutes, or whatever we have.

The fact that we’re not able to be present in the field, and that we’re doing it virtually, takes away a lot from the body language when you’re trying to present. Being on camera brings a little of it back. I always encourage being on camera and continue considering yourself as if you’re still in the field presenting, properly dressed. It does add a value and it does create an impression.

The larger group meetings have always been a challenge because you can’t read the feedback from the audience. The interaction, I think, is compromised. I do feel that for larger panel meetings, I want to go back to face-to-face meetings. But for one-on-one HCP meetings, I think virtual platforms work fine and are even better because it saves time on traveling. Like as I said, the way to make it serious and professional is to consider that you’re actually meeting the person and be properly dressed and be on camera. I think that definitely adds a value to it. Other than that, it’s the same that you would’ve done if you were on the field. 

What do you think will stay the same in terms of interactions after the pandemic?

This is something we are all evaluating and I don’t think we know the answer yet but I have a feeling that internal company meetings will probably stay the same. Something like sales training will go back to being an onsite meeting.

It’s a big meeting; it’s more than five people. As soon as it becomes more than five people, and often it’s a class of 50-100 people, at that point just being on video doesn’t drive home the key points. Those things, I think, will go back to as it was before.

I think the biggest change will be these one-on-one HCP meetings. We all had barriers and inhibitions to using technology to do that. A lot of the times, HCPs don’t have access to something like Zoom or Teams or things like that. Now, with COVID-19, I think a lot of them do. I think that is something that will stay the same as it saves a lot of travel time on our part. Now we can reach more HCPs in the same time because we can just schedule one-on-one meetings right after another instead of having to spend two hours flying or two hours driving time in between. I see that as a positive change that will keep going forward.

You’re someone who went from being an MSL to managing a team in a short time. What advice do you have to MSLs who are looking to progress in their career and start to move up the corporate ladder?

The biggest thing that stands out is being proactive. As an MSL, you are given a specific set of tasks but you don’t necessarily need to be within that role. It’s important to network within your company as you have networked to get into this role. You now need to network within your company with your supervisors, with your peers, or with your bosses and make your presence felt. I think it’s important to make your presence felt. How do you make your presence felt?

If there is an appreciation that comes out from the field, it’s sometimes okay to forward it to your boss so that they know that you’re doing well. Your bosses are managing a big team. As in any company or any role, everyone has to find their own way of making their presence felt. It has to be healthy competition. It’s not by killing someone else’s job.

First of all, you have to work hard. If you work hard it will always be noticed. I think hard work is always noticed. Second you have to make sure you bring it to your immediate bosses or higher ups and be visible. Thirdly, I think being proactive, finding new ways to improve your team, how you can collaborate with other teams – these are the soft skills.

Getting into the MSL role, there’s a lot of importance on technical knowledge. Going up the ladder is now a lot about your soft skills – how you interact with people, how you troubleshoot, how you do things on time. Are you responding to emails right away? Are you a pleasant person to talk with? When you do presentations, is that something which is interactive?

From what I’ve experienced, feedback of good people spreads like fire inside a company. If you’re a good presenter, the sales people will now talk among themselves, saying “Oh, I need this guy.” That information flows within the company. As long as you’re the best in what you do you will be noticed and you will go up the ladder. Definitely do not be shy. Try to be proactive. Try to be energetic. That’s the only way to go up the ladder. And of course, keep updating yourself. If you are working on one particular product, it doesn’t hurt to learn about some other product. Who knows? One day you may be called upon to work on that. It’s always important to stay updated technologically or knowledge-wise. 

What are some steps you took or advise others to take to improve themselves and just keep themselves constantly building knowledge and moving forward?

I think to move up the ladder, it’s important to expand your resume beyond just being able to grasp one product and giving presentations on it. It’s important to wear multiple hats where you know regulatory, what FDA guidelines are, what marketing teams do, what reimbursement teams do, and what your R&D teams do. That’s where medical affairs comes into play.

MSLs are part of Medical Affairs. I think to go up the ladder, you become an MSL, Senior MSL, Director of MSLs. But then the next steps would be Director of Medical Affairs. To do that you need to be proficient in these other things, which you don’t normally do as an MSL. Get trained, get certifications in something broader than medical affairs or in regulatory affairs. Things like that will help differentiate you from someone who is just coming off as a PhD or an MDM starting off as an MSL.

You have to realize if you give some materials to read – all of us are PhDs or MDs—we can look at some PowerPoint slides, we can develop our knowledge and everyone will do well when they go present in the field. We have to find ways to distinguish ourselves from the rest of the team or from the freshers who are coming in as an MSL. The only way to do that is to expand our product knowledge in the company and also expanding our knowledge into what a clinical trial is. Can you actually run a clinical trial? If someone tells you, “We need a randomized controlled trial,” you manage that trial. Project management skills, clinical trial, regulatory affairs, reimbursement scenarios – these are important skills to learn and to put on your CV so when a selection happens again for the next role, people will see, “Ok this guy knows better than the rest of the team and this guy needs to be promoted up.” 

Jaideep Banerjee, Ph.D, is a Senior Manager at Smith & Nephew