Medical affairs plays a crucial role in the healthcare industry due to its responsibility in bridging the gap between clinical development and commercial operations. By providing scientific expertise, medical affairs ensures that healthcare professionals receive accurate, balanced and up-to-date information about therapeutic areas and medical products/devices. This contributes to better patient outcomes, enhances the credibility of pharmaceutical companies, and supports regulatory compliance. Moreover, medical affairs teams engage in valuable real-world evidence generation, and also engage in pivotal interventional trials, fostering innovation and driving advancements in medical science. This blog explores the key competency areas of a successful Medical Affairs professional.

To excel in medical affairs, medical professionals should master five key competency areas. ACMA formulated these five competency areas through a rigorous advisory board process involving prominent industry experts in medical affairs. The five pillars that encompass the necessary competencies for medical affair professionals are life sciences understanding, regulatory & compliance, technical competencies, soft skills & business acumen, and processes. These standards represent the essential skills needed for organizations, ultimately enhancing patient services.

Let’s review each in more detail.

Key Competency: Life Sciences Understanding

This competency area covers traditional pharmaceutical, medical devices, and diagnostics industries, as well as emerging areas such as artificial intelligence (AI). The healthcare landscape is constantly evolving, making it essential for medical affairs professionals to stay on top of current issues.This knowledge is crucial as pharmaceutical companies, medical device manufacturers, and diagnostics firms operate under distinct regulatory frameworks, each requiring tailored approaches and communications.

Having a broad understanding of various sectors enhances their ability to convey complex scientific information accurately and efficiently to various stakeholders. By having expertise across emerging areas, medical affairs professionals can stay ahead and anticipate the ever changing needs of stakeholders and their partners. This competency enables medical affairs professionals to provide enhanced cross functional support across various life sciences domains such as commercial strategies, regulatory affairs, research and development, and many more. With ACMA’s Board Certified Medical Affairs Specialist (BCMAS) certification program, medical affairs professionals have the opportunity to master this key competency right from the beginning, as it is covered extensively in the first three modules. This foundational knowledge equips them to effectively navigate the complexities of the healthcare industry and stay ahead of emerging trends and challenges.

Key Competency: Regulatory & Compliance

Regulatory compliance is a critical pillar that ensures medical affairs professionals and MSLs operate within the appropriate, ethical, and compliance guidelines. This competency emphasizes understanding the relevant regional regulatory bodies, submission and review of applications, and engaging with external stakeholders. This includes complying with regulations and guidelines established by health authorities, such as those enforced by the U.S. Food and Drug Administration or the European Medicines Agency.

Compliance plays a key role in any organization as it ensures that all activities are conducted correctly and in adherence to pharmaceutical regulations. It is a competency that is needed at every role. Whether medical affairs professionals are interacting with healthcare professionals in the field or at headquarters, it is essential to ensure that these interactions are conducted appropriately. Being well aware of the regulatory rules can lead to trust and proper conduct can foster ongoing collaboration between medical affairs professionals and healthcare providers. Furthermore, a thorough understanding of regulatory compliance enables medical affairs professionals to prevent errors that could otherwise compromise patient safety. It is crucial for every individual to possess knowledge of compliance. Understanding the rules, regulations, and ethical guidelines outlined by the pharma code ensures that professionals make informed decisions and conduct themselves appropriately. Accountability remains essential, even with dedicated compliance teams in place. ACMA’s BCMAS certification program further reinforces this key competency of regulatory and compliance throughout multiple modules.

Regulations can vary by region/country, so it is critical that medical affairs professionals have a deep understanding of this competency. There are different regulatory and compliance regulations in each region, and ACMA offers region specific BCMAS certifications that highlights the regulatory affairs that govern that region. By mastering these areas, medical affairs professionals can ensure that the interactions and communications on an individual level uphold the highest standards of integrity and responsibility.

Key Competency: Core Technical Competencies

Core technical competencies such as evidence-based medicine, clinical trial analysis, and health economics and outcomes research (HEOR) are crucial for medical affairs professionals. Clinical trials are the cornerstone of evidence-based trials and the data they generate forms the backbone of a medical affairs toolkit, including product knowledge and educational materials. Having a strong technical foundation in every role is crucial for successful product development and launches. Medical affairs professionals equipped with expertise in evidence-based medicine possess the critical ability to interpret and apply scientific data accurately, thereby ensuring that healthcare providers receive reliable information on the efficacy and safety of medical products and a deep understanding of therapeutic areas. This knowledge enhances the credibility of pharmaceutical companies and also fosters trust among healthcare providers and patients alike.

These competencies not only enable medical affair professionals to provide valuable feedback, but also facilitate informed and intellectually engaging discussions with healthcare providers. All of these competencies are covered in ACMA’s BCMAS certification program, providing a comprehensive technical knowledge base that serves as a foundation for medical affairs professionals. Therefore, mastering core technical competencies for different roles in medical affairs can provide invaluable support to various cross functional teams.

Key Competency: Soft Skills & Business Acumen

Effective communication and presentation skills are crucial for medical affairs professionals to clearly and concisely explain complex scientific data to diverse audiences, from healthcare providers, patients (as appropriate and according to local regulations), and industry colleagues. These professionals must be adept at tailoring their messages to suit different audiences, ensuring that the information is accessible and relevant to each group. Understanding and listening to the healthcare provider and different collaborative teams are critical for engaging in meaningful dialogue. Medical affairs professionals are not only responsible for presenting data, they are also responsible for discussing the data as well. By doing so, medical affairs professionals can foster trust and credibility, which are essential for successful collaboration.

It ultimately comes down to adaptability, being able to tailor communication based on the needs and personality of the people they work with. Whether communicating with a highly technical audience or with patients who may have limited medical knowledge, the ability to adjust the level of detail and complexity is vital. ACMA recognizes the importance of these skills and incorporates them into their BCMAS certification program. This program includes a module specifically developed with input from both medical affairs experts and communication specialists. This module highlights the essential presentation and communication skills required for medical affairs professionals. By mastering these communication & presentation skills, medical affairs professionals can ensure that scientific data is accurately interpreted and applied in various contexts. This leads to better patient outcomes, more effective product launches, and stronger relationships with healthcare providers and other stakeholders.

Key Competency: Processes

This competency focuses on key functional areas within medical affairs that proficient experts should excel in, as these involve their daily activities. This includes publication practices, advisory boards, continuing medical education, investigator sponsored research, and post-marketing studies. Each of these activities plays a pivotal role in advancing medical knowledge, ensuring product efficacy and safety, and maintaining regulatory compliance. Having a comprehensive understanding of processes is essential for medical affairs professionals to succeed and be more efficient in their work. Understanding the responsibilities of their cross-functional counterparts is crucial for medical affairs professionals, as it ensures the efficient execution of medical affairs activities and helps maintain trust.

Medical affairs professionals who possess knowledge across multiple cross-functional areas can adeptly communicate scientific findings to healthcare providers, thereby enhancing informed decision-making and patient care. Engaging in advisory boards allows them to collaborate closely with key opinion leaders to shape strategic initiatives and guide product development. Continuing medical education (CME) activities are vital for updating healthcare professionals on new therapies and treatment guidelines, reinforcing the importance of ongoing learning within the medical community. Similarly, investigator sponsored research (ISR) involves collaboration with external researchers to generate real-world evidence that supports product efficacy and safety claims. Post-marketing studies play a crucial role in monitoring the long-term effects and safety profiles of pharmaceutical products post-launch, ensuring ongoing compliance with regulatory standards and addressing emerging healthcare trends.

Medical affairs professionals are required to work with multiple teams throughout the clinical trial process and having a solid understanding of each role’s responsibility leads to a smoother workflow, ultimately better serving patients. Therefore, medical affairs professionals need to develop expertise in all functional areas in order to ensure successful collaborations and ACMA’s BCMAS certification program can support this growth. BCMAS ensures that certified individuals are well-prepared to drive innovation and uphold the highest standards of patient care in the dynamic field of medical affairs.

BCMAS Impact

Ali Anwar, BPharm, MBA, BCMAS is a pharmaceutical professional with over 16 years of experience, brings a wealth of expertise across various disciplines including sales, learning & development, and medical affairs in different multinational organizations. Currently serving as the Medical Director for Saudi Arabia at AbbVie biopharmaceuticals.

Dr. Anwar discovered the significant value of the BCMAS program upon completing it three years ago. Despite his extensive background in medical affairs, he found the program to be both comprehensive and practical. He strongly recommends the program to individuals seeking a career in medical affairs or existing professionals aiming to broaden their knowledge and propel their careers forward.

Back in 2017, while researching the role of Medical Affairs in pharma for his MBA thesis, Ali Anwar came across some interesting insights on the skills needed for success in this field. Here's what various industry players identified as key competencies for medical professionals.

Conclusion:

The BCMAS program is a comprehensive, self-paced online course that covers the five key competency areas essential for medical affairs professionals. The program consists of 20 modules each designed to build expertise across critical skills and knowledge, preparing participants for success in medical affairs. As the first accredited board certification in medical affairs, BCMAS has gained recognition across numerous pharmaceutical organizations, positioning professionals for career growth and leadership roles. This increasing recognition demonstrates BCMAS establishment as an industry benchmark, emphasizing competency and preparedness of certified professionals for crucial leadership positions. This certification provides a thorough and flexible way for professionals to enhance their expertise and elevate their careers, ensuring they meet the evolving demands of the healthcare industry.

The role of medical affairs plays a vital role between clinical development and commercial operations. Through its dedication to scientific expertise, regulatory compliance, and effective communication, medical affairs ensures the dissemination of accurate information to healthcare professionals, thereby enhancing patient outcomes and fostering trust in pharmaceutical advancements. The BCMAS certification program stands as a cornerstone in equipping professionals with the diverse skill set needed to excel in this evolving field. By mastering core competencies ranging from life sciences understanding to soft skills and business acumen, BCMAS-certified professionals are well-prepared to navigate complex challenges and drive innovation in medical science. With its comprehensive curriculum and industry recognition, BCMAS not only sets the standard for excellence in medical affairs but also paves the way for continued advancement and success in improving global healthcare outcomes.

Disclaimer:

The opinions expressed here belong solely to Ali Anwar and do not reflect the views of their employer.

References:

Dixson, K., Fernandez, J., Caillaud, E. Maximizing Impact: The Value of Board Certification for Medical Affairs and MSL Professionals [Webinar]. 2024. Accreditation Council for Medical Affairs. https://medicalaffairsspecialist.org/resources/webinars/value-of-board-certification

Anwar A. Assessing the role of Medical Affairs in Pharmaceutical industry in Saudi Arabia. 2017 (unpublished)