The Role of Medical Affairs in the Pharmaceutical Product Lifecycle

For decades, Medical Affairs was considered a support area: it reviewed promotional messages, answered technical questions, and served as the link with physicians and healthcare professionals. That description no longer reflects the reality of the industry. McKinsey & Company found that Medical Affairs is consolidating as the third strategic pillar of pharmaceutical organizations, alongside Research and Development and Commercial — not merely as a support function between the two ^[1].

What's driving this shift? McKinsey points to several converging factors: the growing complexity of mechanisms of action and new therapeutic modalities, the generation of real-world evidence, and mounting pressure on the value and cost of therapies ^[1]. In that context, Medical Affairs becomes the function best positioned — through medical expertise and credibility with different audiences — to be the natural owner of the organization's scientific knowledge across the entire product lifecycle ^[2].

This evolution isn't happening in a vacuum. An analysis published in Pharmaceutical Medicine documents how the function, originally limited to medical information, promotional material review, and general compliance, has expanded into evidence generation, medical data analysis, and, in some organizations, leadership of patient support programs ^[3]. That expansion brings a demand with it: Medical Affairs teams today need greater strategic capacity, project management, and business thinking, not just scientific rigor ^[3].

For brands building or strengthening their medical function, this has a direct practical implication: deliverables can no longer be thought of as isolated compliance pieces. The dossier, the evidence matrix, the Q&A, and the medical presentations need to be designed as a coherent system that supports strategic decisions — on launch, positioning, access — not just as supporting documentation.

That is, in essence, the underlying shift: from a function that documents what others decide, to a function that informs what the organization decides.