To our knowledge, this is the first study to analyze both the structure and the situation of medical departments in the pharmaceutical industry, focusing on the different positions, functions, and profiles of the professionals who belong to it. The results presented in this study indicate that most of the respondents work in laboratories with an international scope with medical departments composed of teams of mainly up to five workers or between 11 and 20 people. Generally, these departments include up to four Medical Advisor positions, with the number of MSLs being more variable (mainly 1, between 6 and 10, or more than 20). Most respondents indicated that the Medical Affairs and Medical Information departments report to the Medical Directorate, with Pharmacovigilance, Operations and Strategy, Medical Education, and Clinical Operations also reporting to the Medical Directorate in some cases. In terms of the profiles of the different professionals, the Medical Director is usually a medical graduate with more than 20 years of experience, the Medical Manager a medical or pharmacy graduate with between 6 and 20 years of experience, the Medical Advisor a medical, pharmacy, or biology graduate, with approximately half holding a PhD, the MSL mostly a biology graduate, and the Medical Information and Pharmacovigilance Technicians a pharmacy graduate, with some cases of biology graduates in the first case. Finally, regarding the roles of the different positions, the Medical Director generally has strategic functions, the Medical Advisor has KOL management and evidence generation functions, and the MSL is responsible for insights gathering as well as KOL management.

In 2013, AMIFE carried out a survey among its partners to determine the formation of roles. The survey herein was designed to collect data on and analyze both the structure and the situation of medical departments in the Spanish pharmaceutical industry, focusing on the different positions, functions, and profiles of professionals. In that year there was a change of technical secretariat within AMIFE, with the new members deciding to carry out a study with the data available at that time in the organization’s database. Through that internal and unpublished study, it was observed that the available information was scarce. Therefore, when the working group of medical directors, composed of 65 medical directorates of the Spanish pharmaceutical industry, was created in 2019, they began to develop projects to increase the information on the structure, organization, number of professionals, and their training and reporting lines within these departments, among which is this study. In fact, the data presented here represent for the first time that a rigorous study has been performed which includes this type of information, which will serve as the basis and commitment of the working group to update and enrich this knowledge on a regular basis.

The results of this study indicate that most of the respondents worked in pharmaceutical companies with an international scope and that medical departments were composed of teams mainly of up to 5 people or between 11 and 20 people. These departments generally included up to four medical advisor positions; the number of MSLs was more variable. Most of the respondents indicated that the medical affairs and medical information departments reported to the medical directorate, as did the pharmacovigilance, operations and medical strategy, medical education departments, and in some cases, the clinical operations department.

The profiles of the different professionals varied by different positions, with most being graduates in medicine, pharmacy, or biology.

Finally, regarding the roles of different positions, medical directors generally had strategic functions, medical advisors managed opinion leaders and generated evidence, and MSLs collected insights and managed KOLs. Recently, a report by the consulting firm McKinsey & Company, designed to predict the evolution of the role of medical affairs in the coming years, indicated that certain aspects of medical department activities should be updated. Such activities include the integration of data analysis and digital participation [7].

In the coming years, evidence generated from phase IIIb and IV studies, from real-life data, and from health systems and pharmacoeconomics will be of vital importance for microanalyses of information that consider the individual needs of patients. In this process, medical affairs teams, thanks to their in-depth knowledge of the scientific field, access to data, and their close relationship with stakeholders, will be well positioned to find the evidence needed to improve the health of patients. The generation of these robust and patient-centered data models will accelerate patient access to treatments, realizing clinical and economic value so that each patient receives the most correct drug at the most appropriate time.

Medical departments should transform and personalize interactions with health professionals, health and academic authorities, research centers, scientific societies, and patient associations based on their needs, incorporating tools and digital contacts designed to provide specific information, support tools, and innovative techniques in the field of training and scientific information.

An intensification of the work of the medical department is recommended to better provide a medical strategy that aligns with the needs of companies. This transformation will allow professionals within medical departments to change public opinion of the industry, bringing patients to the forefront and rethinking the measurements of the performance and activities of companies by focusing on patients. This transformation is expected to occur through the acquisition and development of human talent within the medical area and through an approach to the management and distribution of resources focused on individual patients. Individuals who work within medical departments should not only have excellent technical skills and competencies, such as leadership, communication skills, and teamwork, but also be capable of sufficiently managing new health technologies.

The transformation and evolution of medical departments in the industry has led to the emergence of new roles, such as those of strategy and medical operations, whose function varies based on the structure of each company but usually includes medical excellence aspects (KPIs and dashboards for monitoring medical activity and the collection of insights) and the creation and facilitation of tools (including digital tools) for medical teams and the incorporation of project management functions in projects within the medical department itself and in strategic transversal projects of companies through medical affairs.

Due to the different currents and restructuring that have occurred in different companies in the sector and that have generated some confusion about the value and mission of medical equipment within the industry, it is important for the Association of Physicians of the Pharmaceutical Industry (AMIFE) to create a manifesto (Online Resource 1) that highlights the main attributes that provide fundamental value, not only for the industry, but also for the ultimate beneficiaries, i.e., patients and society.