The Strategic Rise of Medical Affairs: From Compliance to Core Pharma Decision-Making

Introduction

From the fringes to the mainstream, Medical Affairs is evolving. No longer confined as an afterthought and for the post-launch activities for regulatory and compliance requirements, Medical Affairs is increasingly sitting at the heart of pharmaceutical strategy.

At the recently concluded Reuters Pharma 2025, a lot of leaders were seen asking, “What’s next?”; The shift is not optional. It is structural.

As detailed in our whitepaper, this evolution is driven by both external market pressures and internal expectations. Medical Affairs is now expected to deliver insights that shape pipeline strategy, ensure regulatory alignment, and provide the scientific credibility that sales and marketing teams increasingly lack access to.

Let’s unpack the structural changes pushing Medical Affairs into the spotlight—and why your organization must keep up.

From Fragmented to Foundational

The term “Medical Affairs” may have originated in the 1960s, but its role today is far more pivotal. For many pharma organizations, it's evolving into a core business function—no longer just a scientific communications team.

Key drivers of this change, as outlined in our whitepaper, include:

• Regulatory tightening: With legislation like the Sunshine Act limiting rep–physician access, pharma needed a non-promotional, scientifically credible channel.
• Physician access drop-off: Only 47% of U.S. physicians are accessible to pharma sales reps today. In oncology, that falls to just 27%​.
• Rising need for scientific nuance: Complex therapeutic areas require deeper, medically accurate dialogue—something Medical Affairs is designed to deliver.

With clinical and commercial teams increasingly reliant on insights from the field, Medical Affairs is becoming the internal compass for both product strategy and external engagement.

The Medical Affairs Value Chain: More Than Just MSLs

The whitepaper outlines how Medical Affairs today encompasses a range of critical functions:

• Key Opinion Leader (KOL) Engagement
• Medical Education & Training Programs
• Scientific Insight Generation
• Clinical Development Support
• Publication Planning
• Health Economics and Outcomes Research (HEOR)
• Real-World Evidence (RWE) Gathering
• Medical Data Repository Maintenance​

This is not a passive support function—it’s a network of scientific activity that underpins both pre-launch and post-launch success. Medical Affairs teams are managing educational programs, feeding insights into trial design, helping ensure payer alignment, and tracking product performance across markets.

The Shift in Internal Influence

According to the whitepaper, there is a significant realignment of power within pharma organizations. Previously siloed, Medical Affairs teams are now:

• Collaborating with R&D to refine clinical trial protocols based on feedback from HCPs and patient advocates
• Providing data to commercial teams for more relevant positioning
• Supporting HEOR teams with medical data and payer-relevant outcomes evidence

As a result, the function is earning not just a seat at the table, but a leadership voice—particularly in go/no-go decisions, label expansion discussions, and lifecycle management.

The Leadership Takeaway

The question for pharma leaders isn’t “should we strengthen our Medical Affairs team?”

It’s:
“Have we equipped Medical Affairs to lead, not just support, our strategy?”

Because the teams that are still viewing Medical Affairs as reactive or compliance-oriented will miss the bigger opportunity—to embed them as a source of foresight, not just insight.

That means enabling them with:

• Better tools for insight capture (not just CRM logs)
• A platform for field intelligence to influence trial and launch decisions
• Clearer integration with commercial, R&D, and market access teams
• Increased investment in analytics, content generation, and field deployment

Before we conclude:

From being relegated to post-launch support, Medical Affairs is now expected to influence every stage of the product lifecycle—from early clinical development to formulary access, from real-world insights to physician education. It’s a role shift that isn’t just semantic—it’s structural.

But is your organization structurally prepared?

Want to Dive Deeper?

Our whitepaper, “How Medical Affairs is Driving Pharmaceutical Companies’ Decision Making & AI/ML’s Role in Enhancing the Medical Affairs’ Contribution,” is designed to provide leadership teams with a clear, accessible, and actionable roadmap.

✅ Detailed breakdown of MA functions
✅ Strategic alignment with AI/ML tools
✅ Functional challenges & future-proofing tips
✅ Designed for internal business cases

Download White Paper

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