20 Terms You Need to Know for Medical Affairs

Medical Affairs is a growing function in the life sciences industry that connects science, clinical practice, and business strategy. As the role expands beyond scientific support into strategic leadership, it’s important for professionals—especially those new to the field—to understand the language used every day.

Here are 20 essential terms organized into four key areas of Medical Affairs:

1. Scientific Engagement

1. Key Opinion Leader (KOL):

A respected healthcare professional or researcher who influences clinical practice and decisions in their field.

2. Medical Science Liaison (MSL):

A field-based professional who shares scientific information with healthcare providers and gathers insights from experts.

3. Advisory Board:

A meeting with external experts to gain feedback on clinical data, strategy, or unmet medical needs.

4. Medical Congress:

A scientific conference where new research is presented and where companies engage with clinicians and researchers.

5. Continuing Medical Education (CME):

Educational programs for healthcare professionals to maintain knowledge and licensure, often supported by Medical Affairs teams.

2. Evidence Generation

6. Randomized Controlled Trial (RCT):

A study where participants are randomly assigned to treatment or control groups to measure effectiveness under controlled conditions.

7. Real-World Evidence (RWE):

Data on how a treatment performs in real-life settings, such as hospitals or clinics, outside of clinical trials.

8. Investigator-Initiated Trial (IIT):

A clinical study led by a physician or researcher, not the pharmaceutical company, though it may be supported with funding or drug supply.

9. Health Economics and Outcomes Research (HEOR):

Research that evaluates the cost-effectiveness and impact of a treatment on patient outcomes and healthcare systems.

10. Publication Planning:

The process of organizing and releasing clinical study results in journals or conferences to communicate scientific findings.

3. Compliance & Review

11. Medical-Legal-Regulatory (MLR) Review:

An internal review process to ensure that content is accurate, evidence-based, and compliant with regulations.

12. Pharmacovigilance:

The monitoring and reporting of drug safety issues, including the collection and analysis of adverse event reports.

13. Off-Label Use:

Using a medicine in a way not approved by regulators, such as for a different condition or patient group.

14. Sunshine Act (Transparency Reporting):

A law requiring companies to disclose payments or gifts given to healthcare professionals to ensure transparency.

15. Industry Code of Ethics:

Guidelines set by pharmaceutical associations to ensure that interactions with healthcare providers are ethical and professional.

4. Strategy & Planning

16. Medical Affairs Strategic Plan:

A roadmap outlining how Medical Affairs will support a product or therapy area through education, evidence, and engagement.

17. Patient-Centricity:

An approach that places patient needs, experiences, and outcomes at the center of Medical Affairs activities.

18. Artificial Intelligence (AI):

Technology used to analyze data, automate processes, and improve insights in medical strategy and communication.

19. Omnichannel Engagement:

A coordinated approach to reach stakeholders using multiple channels—such as email, webinars, and in-person meetings—in a consistent and personalized way.

20. Key Performance Indicator (KPI):

A measurable goal or metric used to evaluate the success of Medical Affairs activities, such as publication output or stakeholder engagement.

Final Thoughts

Medical Affairs is a dynamic and evolving field that requires a deep understanding of both science and communication. By mastering these 20 terms, new professionals can better navigate their roles and contribute meaningfully to their organizations. Whether you’re speaking with clinicians, planning strategy, or reviewing data, knowing the language of Medical Affairs is your first step to success.

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