10 lessons learned during my first year in ad promo

Feature ArticlesFeature Articles | 24 December 2020 | Citation  |  PDF Link PDF

After completing my industry rotation as a 4th year pharmacy student, I knew I wanted to pursue a career in regulatory affairs (RA) advertising and promotion. I had the opportunity to attend a meeting for a branded promotional piece with medical, regulatory, legal, and marketing representatives and instantly I was drawn to the conversation and the overall collaborative process. I remember being so engaged in the discussion that I even made a proposal that was accepted by the team. I left the meeting feeling energized, inspired, and yearning for more. I was not exactly sure at the time how I would navigate into advertising and promotion (ad promo). However, I was confident that my scientific background, coupled with my creative energy fueled by my training as a dancer, would make me a good fit for the role.
Accepting my first ad promo position was a huge transition for me. My previous roles working as a postdoctoral fellow in academia and as a contractor in clinical trial disclosure operations were both very different from supporting high-impact commercial activities. I had to leverage the transferable skills I learned along the way, while remaining open to learning new techniques to help me thrive in this new chapter in my career. I quickly realized my new role was much more than reviewing promotional pieces and knowing the regulations that governed prescription drug promotion. I have learned many lessons during my first year in ad promo, but I offer the following tips as the 10 most valuable from my own personal experience. I encourage readers to follow this advice if entering the field of regulatory affairs advertising and promotion.
1. Read, read, and RE-READ regulations, guidance documents, product regulatory history, and OPDP enforcements
It is important within any role to build a solid foundation in the subject matter outlined in the job description. From an ad promo perspective, the Code of Federal Regulations Title 21 202.1 Prescription Drug Advertisements1 as well as guidance documents issued by the Office of Prescription Drug Promotion (OPDP)2 are usually covered during the onboarding process.
One of the best ways to develop expertise as a regulatory professional is to read OPDP enforcement letters. First, I would recommend reviewing the violative promotional material and complete your own regulatory evaluation. Then, read the enforcement letter to see how your thinking and decision-making aligned with the OPDP reviewer. This way, you can really begin to think like a regulator and apply this thought process in promotional reviews at your company.
In addition, being familiar with the regulatory history of the product or products you support and reviewing company-specific standard operating procedures are also critical to your early success. I recall reading items before my first day on the job and not fully understanding the nuances of the content. I found myself reading and re-reading documents multiple times before concepts started to click. Sometimes, I would read items on my computer and then print out a copy to highlight and take notes. Reading regulatory documents is different from reading your favorite novel or magazine. Some of the illustrated concepts are not straight forward and there is room for readers to interpret the content differently.
During onboarding, it is also critical for you to be well acquainted with any OPDP advisory comments your company has received related to the brand and therapeutic area you support. There are only certain instances in which companies seek OPDP advisory, so it is critical for ad promo professionals to be familiar with those communications. A good practice is to first familiarize yourself with the advisory submission and then read the comments received by OPDP to fully appreciate the details of the feedback provided. Another great tip for those who are newer to ad promo, or transitioning to a different company, is to set up time with colleagues who previously supported the brand you are now responsible for to help you gain insight and background. A quick chat with a colleague can be enlightening and help inform your decision-making during your own promotional reviews.
2. Building relationships with cross-functional partners is key
Of course, building relationships with coworkers is important. However, prior to my role in ad promo I did not realize just how much established relationships can positively influence your daily activities. Initially, I only engaged with my cross-functional partners at weekly meetings as we were negotiating messaging for promotional materials. I really didn’t know much about my colleagues beyond what brand they supported and what department they worked in.
After taking the initiative to set up informational meetings with my business partners, I had the opportunity to learn more about them. Topics we discussed included where they were born and raised, family life, and their career journey. Often times we discovered that we enjoyed the same TV shows or the same food. For me, making those connections with colleagues significantly increased my work productivity. Meeting new people and hearing their stories truly energizes me. Once that deeper connection was made, promotional review meetings became less stressful and more enjoyable. I became a better partner, one who was more efficient at coming up with solutions to move projects forward in the process.
Networking and building relationships tend to be easier for extroverts, however, I understand not everyone fits that personality type. If you are more of an introvert and meeting new people does not come as naturally to you, my advice would be to start with a small step. A simple hello, a genuine compliment, or asking “how was your weekend?” could be the beginning not only of a great conversation, but a long-lasting partnership. In our new virtual environment, networking and making connections can be a bit more challenging, but it’s not impossible. Don’t be afraid to set up a virtual coffee chat to get to know someone. You can work on building key relationships from the comfort of your own home.
3. Be prepared to explain to your rationale
One of the simplest, yet most difficult questions to answer is “Why?”. As ad promo professionals, we are likely familiar with questions and statements such as “What’s the regulatory rationale?” or “Help me understand…”.
When I first heard these phrases I would get defensive. Why is the team challenging me on this topic? Is this what others experience? Am I doing something wrong? It wasn’t until I attended an ad promo conference where I had the opportunity to connect with others in the field and come to fully understand that these experiences are common in the ad promo review process. Both presenters and attendees at the conference shared similar stories, and I remember it being very refreshing to hear. Now, when I’m faced with questions such as “What’s your regulatory rationale?” instead of becoming defensive, I explain my position and reference enforcement letters and/or relevant regulatory history as we discussed in Lesson #1. This question really provides regulatory an opportunity to educate, share our expertise, and demonstrate our value on the team. After explaining my rationale and/or main concerns to my team, we are able to have a productive conversation about compliant solutions. Honestly, I enjoy when my partners are curious about my regulatory position. Engaging in difficult conversations and working with others to find viable paths forward has only improved my performance and expanded my influence on the teams I support.
4. Position yourself so leadership has your back
Once you have evaluated a project and anticipate the conversation could become contentious, it is important to gain alignment with your leadership. Give your manager visibility to the project and schedule time to discuss it before the promotional review meeting, if needed. Be prepared to explain your perspective and rationale with your leader or leaders, as discussed in Lesson #4, and gain alignment. Your manager and other leaders within your organization may be able to provide historic perspective on topics that were discussed before you joined the team. Having that background and relevant history can only enhance the conversation with your business partners. Some conversations may be contentious, but as a team you will be able to come up with different options. Other conversations may need to get escalated and that is also okay. If leadership involvement is required, the key is to ensure you and your manager have already discussed the topic so that he or she can best support you and your position during the escalation meeting.
5. Negotiation ≠ war
This is an important concept that all regulatory ad promo professionals should appreciate. During my first year, I remember preparing for promotional review discussions almost as if I were preparing for war. I would come up with solutions that I expected the team to automatically accept. Instead of putting more energy into explaining the larger regulatory issue, I was spending a lot of time trying to convince the team to accept the solution I came up with. From my experience, it is best to approach negotiations with the mindset of, “How can we get to a win-win for both parties involved?”.
Try looking at your promotional review discussions as the “The team versus the project” instead of “Me vs. You”. Changing your perspective can not only make a huge difference in the project outcome but can also have an impact on your overall mood coming out of challenging meetings. When I went into negotiations as if I were preparing for war, I would leave the meeting feeling mentally exhausted and completely drained. Now, I often leave meetings feeling a sense of accomplishment simply by having shifted my mindset to being more collaborative. This is not to say every meeting with cross-functional partners will necessarily be easy and straightforward. Challenging topics arise and healthy debates are good for the business. However, modifying your style can make a huge difference and lead to positive results.
6. Don’t take it personally
In Lesson 3, I shared with you some of the difficult questions often presented to regulatory ad promo professionals and how that was a new experience for me. Since I was not required to negotiate regularly in my previous work roles, explaining my rationale and being in meetings where others disagreed with my perspective took some adjustment. One thing that helped me get used to this environment was taking time to understand the overall goal and being aware of possible external factors that could be influencing the discussion. Business expectations can vary at different points in the year, meaning stress and pressure may carry over into various conversations. During these moments, the best thing to do is empathize with your colleagues and find ways to be a good partner. As mentioned in Lesson 5, instead of the mindset “Me vs. You”, change your perspective to “Us vs. The Project”.
7. Find a mentor
It is vitally important, not only for the ad promo role, but in your career to have at least one trusted mentor. Having someone to discuss ideas, ask questions of, and engage in candid conversations without fear of being judged is truly invaluable. My mentor always reassured me that the feelings I was experiencing when I first joined the field were completely normal and that I would start feeling more comfortable in the role over time. “Give yourself some grace” or “You’re doing better than you think you are” are statements I’ve heard on more than a few days. Sometimes it can feel like your world is turned upside down when starting a new role, especially when you are accustomed to not only meeting, but exceeding expectations.
One piece of advice is to not apologize for being a new team member. Instead, embrace the fact that you are new to the team and show your peers that you are excited to come up to speed so you can better support broader initiatives. Take it as an opportunity to be a sponge and soak up as much knowledge as you can from both your regulatory and cross-functional colleagues. On those days when  you may feel you are not operating at your best, it’s a wonderful feeling to have a mentor who can help motivate you or help you overcome a challenge you may be facing.
I had the privilege of having several mentors within my department, however, I understand this may not be the case for others, especially if you are working at a smaller pharmaceutical company. If this is you, find a mentor outside of your company. Be more intentional about networking and attend ad promo conferences to meet other regulatory professionals in the field who are willing to mentor you. Spark up a conversation during a networking breakout session and make sure to follow up after the conference. Mentors outside of your company are just as valuable as mentors within your company.
8. Ask questions, and LOTS of them
Throughout my academic and professional career, I have always been told there is no such thing as a dumb question, yet during my first year in ad promo I found myself hesitant to raise my hand. It can be intimidating to ask questions, especially in large meetings and especially if are a new employee. You don’t want to sound incompetent or ask a question that everyone already knows the answer too. More often than not, I have had positive experiences when I asked questions to the team. I have found that asking questions either provides clarity for others or someone else builds off my question because they had a similar inquiry.
Because we deal with many cross-functional partners in the promotional review process, it is usually better to confirm everyone is on the same page by asking clarifying questions. There have been several situations in which I asked a question in a meeting and someone would respond with “That is a great question, let me get back to you” or “That is a great segue to our next topic.” Other times, when I was more apprehensive and decided to ask my question privately in a one-on-one conversation, I would hear responses such as “Why didn’t you ask that on the call? That would have been a good topic to discuss while everyone was on the line.” Asking questions also signals to others that you are actively listening and engaged in the discussion. People may view you in a positive light because you had the courage to speak up and facilitate interesting dialogue. Think about it: If you were giving a presentation on a topic that you are excited about and well prepared for, would you rather present in front of a disinterested audience or answer questions from an engaged audience?
9. Confidence is EVERYTHING
Confidence takes a while to build up in any new role. What helps build that confidence first and foremost is subject matter expertise (see Lesson 1) and experience over time. After you’ve been in the role for a while, you start building key relationships (see Lesson 2) and negotiations no longer feel like war (see Lesson 5). Building confidence is something I continue to work on everyday as part of my own development journey. Once you start believing that you truly know more than you think you know, you will become more confident in your abilities. Both your cross-functional partners and the leaders on your team will begin to take note of your improved decision making skills and your evolving executive presence.
10. Make the role your own
Once you have established yourself on the team and developed confidence in your own abilities, the fun part is to make the role your own. When I first joined ad promo, I would listen to my regulatory colleagues during meetings and try to mimic their style and approach, but it never worked for me. Why? Well, because I wasn’t being my authentic self. I encourage you to reflect on a few questions – What do I want to be known for? What are my strengths? What makes me stand out from the rest? Asking yourself these questions is the first step in creating your very own personal brand.
These lessons are not only applicable to someone in their first year of ad promo – they can be applied to those who are switching brands, switching teams, transitioning into ad promo, or taking on an ad promo role at a new company. Whichever applies, my advice would be to fully embrace your experiences, even during the challenging times, because it all makes up your unique story. Remember, you are on your own career journey and one day your personal story will help inspire others.
  1. Food and Drug Administration. CFR – Code of Federal Regulations Title 21: Part 202, Prescription drug advertising; Section 202.1, Prescription drug advertisements. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=202.1. Current as of April 2019. Accessed 23 December 2020.
  2. Food and Drug Administration. Office of Prescription Drug Promotion (OPDP). https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp. Current as of 25 November 2020. Accessed 23 December 2020.
About the author
Rene Rabaza, PharmD, RPh, is a manager in US regulatory affairs advertising and promotion at AbbVie Inc. She obtained a doctor of pharmacy degree from the University of Illinois at Chicago College of Pharmacy and a bachelor of science degree in molecular and cellular biology at the University of Illinois in Urbana-Champaign. She can be reached at rene.rabaza@abbvie.com.

Citation Rabaza R. 10 lessons learned during my first year in ad promo. December 2020. Regulatory Focus. Regulatory Affairs Professionals Society.


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