Medical Affairs in the Age of Complexity: From Scientific Support to Strategic Enterprise Integrator

Author(s): Mussa Arvani

Abstract

Regulatory acceleration, expanded reliance on real-world evidence (RWE), and increasing integration of artificial intelligence (AI) into healthcare systems have substantially reshaped expectations placed on Medical Affairs. Accelerated and conditional approval pathways are progressively shifting confirmatory evidence generation into the post-marketing phase, while regulatory agencies have formalized frameworks for incorporating RWE into benefit-risk evaluation and lifecycle decision-making. In parallel, healthcare systems are increasingly conceptualized as learning health systems in which routine-care data inform iterative improvement. This Leading Article proposes a conceptual but operationally applicable framework that positions Medical Affairs as a Strategic Enterprise Integrator, responsible for coordinating lifecycle evidence architecture, scientific exchange, insight translation, and governance across development and real-world settings. The framework is structured around four interdependent capability domains: lifecycle evidence architecture; scientific translation and insight management; cross-functional governance; and AI/data governance, including oversight of large language model (LLM)-supported workflows in medical information and analytics.