The ABCs of Building a High-Impact Global Medical Affairs Function


Maintaining a strong Medical Affairs function is challenging, as they are often plagued by limited resources, personnel turnover, and a rigorous regulatory environment. Despite the vast challenges presented by the clinical development, market education, and regulatory compliance areas, the function continues to grow in stature. Improving the effectiveness of this function is critical for driving business value globally.

Medical Affairs has quickly grown into a global function. Despite the global nature of this function, expenditures and regulatory standards vastly differ based on industry and market types. As Medical Affairs operations rapidly evolve and become more critical, understanding worldwide regulatory parameters also grows in importance. Due to the ambiguity and variance in regulation and compliance standards across the world, many Medical Affairs organizations have a difficult time adjusting to regional differences. Some benchmarked results from a Best Practices, LLC report showed that there are ways to ensure alignment of goals, regardless of geographic location. Important takeaways included:

    A. Align with Corporate Strategy: In order to make these functions successful, leaders must first differentiate themselves from marketing and sales functions. Medical Affairs functions worldwide often struggle to claim a clear directive and to put forward a clear value proposition. By clarifying and aligning strategies, goals, and targets, executives can improve their outputs, encourage synchronization across the globe, and ultimately prove their functional value.

     B. Become Familiar with Worldwide Regulatory Environments: Regulation is often changing, and can be tricky to keep a handle on. Keeping everyone on the same page regarding worldwide regulations can help to alleviate any confusion amongst executives. Effectively coordinating with teams worldwide can help to avoid regulatory hurdles globally.

     C. Continuously Demonstrating Medical Affairs Business Value: Building awareness of the Medical Affairs function is challenging, but key. Respondents mentioned that maintaining a well-defined medical plan that aligns with the overall corporate plan can help to make sure everyone is on the same page. Developing a long-term strategy for the function with well-defined goals can ensure that your function will have the right foundation for success.

The growing importance of the Medical Affairs function coincides with a company’s need to manage the rapidly changing regulatory requirements in today’s biopharmaceutical industry. Learning how to accurately manage these groups, while paying close attention to global changes, is the key to success.

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