Medical affairs are a vital part of any pharmaceutical company’s operations. It covers activities ranging from product development to release and involves scientific communication, medical education, clinical research, and many more.
Critically important, this is a non-commercial team. In other words, these are not salespeople, but they have a massive influence on the marketplace through their combination of scientific, clinical, and business skills.
If you’re interested in pursuing a career in medical affairs or want to know more about this field, this article is for you.
Давайте начнем с самого начала.
Medical Affairs Job Roles
The medical affairs department manages the scientific and medical aspects of a pharmaceutical company’s products.
While specific job titles and roles vary between companies, you will often find these positions in the medical affairs team.
- Medical directors/strategists
- Clinical research associates (CRAs)
- Regulatory affairs specialist
- Medical science liaisons (MSLs)
Let’s explore each role, the skills, and job responsibilities.
The role of the medical director in the medical affairs team is to provide strategic, scientific, and medical guidance on products. They are responsible for forming the medical strategy for their products and managing their execution.
Medical directors must possess strong scientific knowledge of drug development, therapeutic areas, clinical research protocols, and pharmaceutical regulations to lead a team effectively.
Clinical research associates (CRAs)
The clinical research associate in a medical affairs team is responsible for designing, implementing, and monitoring clinical trials. They ensure drug trials are compliant with regulations and create the protocols used for the study.
CRAs must possess strong organizational skills, medical terminology and principles knowledge, and comfort with healthcare systems.
Regulatory affairs specialist
The regulatory affairs specialist in a medical affairs team is responsible for ensuring compliance with regulatory requirements. They are responsible for managing the submission process of new drugs, tracking changes in regulations and policies, and helping develop strategies to address potential concerns.
Regulatory affairs specialists should have a thorough understanding of healthcare regulations and exceptional communication skills to liaise between internal teams and external bodies effectively.
Medical science liaisons (MSLs)
MSLs provide scientific support to key opinion leaders, physicians, researchers, and other external stakeholders. They must deeply understand the disease state, therapeutic area, and treatment landscape to provide medical information and product education.
MSLs should possess strong interpersonal skills and a comprehensive knowledge of relevant regulations, policies, and standards associated with the pharmaceutical industry.
Medical Affairs Software Solutions:
Several software solutions are available to help pharmaceutical companies streamline their medical affairs process, from managing clinical trials to collecting and analyzing medical data. Some of the most common medical affairs software solutions include Veeva Vault and Salesforce Health Cloud.
Medical affairs is a complex field involving managing a pharmaceutical product’s scientific and medical aspects. To succeed in the medical affairs field, individuals must have excellent interpersonal communication, scientific knowledge, and research skills.
The art and science of medical affairs can help improve patients’ lives and advance the healthcare industry.