What Is a Medical Affairs Function Assessment? A Practical Guide
Most Medical Affairs directors have never had their function assessed from the outside. They have run internal reviews, answered engagement surveys and defended budgets. But they have rarely had someone map the whole function against what it should deliver, and tell them plainly where it falls short.
That is what a Medical Affairs function assessment does. And the findings are rarely where leaders expect them.
An assessment is not an audit
The first thing to clear away is the idea that an assessment is a compliance exercise. It is not an SOP check or a training-records review. Those matter, but they tell you whether the function is safe, not whether it is effective.
A function assessment asks a different question: is Medical Affairs creating the value it should, for patients, HCPs and the business, given its people, budget and remit?
To answer it, a good assessment looks at the function the way its stakeholders experience it. Commercial, Market Access, R&D, the affiliates, external experts. Not just the way the organisation chart describes it.
The five areas a good assessment covers
Every function is different, but a thorough assessment covers five areas.
1. Strategy and alignment. Is there a medical strategy that connects to the lifecycle plan, the evidence gaps and the brand plan? Do affiliates execute it, or quietly run their own? Can the team explain in one sentence what Medical Affairs is accountable for in this therapy area?
2. Operations and governance. Who decides what? How long do things take? Where do approvals, budgets and resources get stuck? This is where review processes, planning cycles and global-to-local handovers show their real shape.
3. Team capability. Do MSLs, Medical Advisors and medical leads have the skills the strategy needs? Scientific depth is usually strong. Insight synthesis, stakeholder planning and business acumen are often the gaps.
4. Digital and AI maturity. Are CRM, insights and content systems helping the team or slowing it down? Is AI used inside real workflows, with clear rules, or left to individual experimentation?
5. Commercial-Medical alignment. Do the two functions share priorities and insights within compliance boundaries? Or do they plan separately and meet only when something goes wrong?
What assessments usually find
After years inside global and local Medical Affairs teams, the patterns are consistent.
Insights are captured but not used. Field teams log hundreds of insights. They sit in a CRM, summarised once a quarter in a slide nobody acts on. The information is there. The synthesis is not.
KPIs measure activity, not impact. Interactions, slides delivered and advisory boards held. Easy to count, hard to defend in a budget review. Leadership wants to know what changed because Medical Affairs was involved.
Global and local are misaligned. The global plan assumes affiliates will execute. Affiliates have different priorities, budgets and timelines, so they adapt quietly. Nobody sees the gap until launch.
Decision rights are unclear. Medical Affairs is consulted on everything and accountable for little. That feels safe until a reorganisation asks what the function actually owns.
None of these are failures of effort. They are failures of design. And that is good news, because design can be changed.
How an assessment works in practice
A focused assessment typically runs over several weeks and combines three sources of evidence.
Documents. Medical plans, KPIs, organisation charts, SOPs, governance calendars and recent insight reports.
Interviews. Medical Affairs leaders and team members, plus Commercial, Access, R&D and selected affiliates. The most useful conversations are often with the people who work with Medical Affairs, not in it.
Observation. How a planning meeting runs. How an insight travels from the field to a decision. How long a piece of content takes from draft to approval.
The output should be short and practical: prioritised findings, the evidence behind each one, and a 90-day action roadmap with owners. Not a 120-slide deck that confirms what everyone already suspected.
When an assessment makes sense
An external assessment earns its cost at specific moments:
- Before a launch, when gaps in the medical plan or field readiness become expensive.
- After a reorganisation, when roles and decision rights need to be rebuilt deliberately.
- When a new Medical Affairs head takes over and wants an honest baseline in the first 100 days.
- When leadership starts asking what Medical Affairs delivers. By then, the function needs evidence, not anecdotes.
- When internal reviews keep reaching the same conclusions and nothing changes.
How to act on the findings
The assessment is the easy part. Acting on it is where most organisations stall. Three principles help.
Fix the system, not the symptom. If insights are not used, more insight training will not help. Redesign how insights move from capture to synthesis to decision, and who owns each step.
Start with three changes, not thirty. Pick the findings with the highest impact and the clearest owner. Show progress in 90 days. Then take on the next set.
Measure the change you want. If the goal is greater influence on evidence planning, track how many evidence decisions included Medical Affairs input. Not how many meetings were held.
The question worth asking
If someone outside your function spent a month talking to your stakeholders, what would they say Medical Affairs is for? And would your team agree?
If you are not sure, that is the starting point. Book a 20-minute call to talk through what an assessment would look at in your organisation, or see how the Medical Affairs Function Assessment works.