Building Best-in-Class Capabilities for Medical Affairs: Structure, Scope & Leadership

STUDY OVERVIEW

Recent regulatory changes have pushed Medical Affairs to the forefront of many organizations’ priority list. Growing companies recognize that a robust Medical Affairs function can help them envisage and address challenges in clinical development, market education, and regulatory compliance. Certainly, Medical Affairs leaders are required to evaluate and improve effectiveness to create high-impact function that drives business value. 

This Best Practices, LLC study explores how U.S. and global biopharmaceutical companies are structuring and managing their Medical Affairs organizations. The study also examines the scope of Medical Affairs groups, on a product and geographic level, as well as the leadership in charge of the function. Pharmaceutical, biotech and medical device managers and executives will be able to use this research to determine how their Medical Affairs organizations compare with industry benchmarks.

The study includes four segments: a mature markets segment from 2012 and 2009, a pharma segment, medical device segment, and an emerging market segment.

KEY TOPICS

• Organizational Structure
• Reporting Relationship
• Job Level of Group Leader
• Geographic Span

• Type of structure (i.e. centralization, hybrid, etc.)
• Number of therapeutic areas and compounds/products Medical Affairs oversees
• Medical Affairs group dedication
• Departmental reporting relationships
• Job level of Medical Affairs head
• Geographic span of organization

• Centralization of Medical Affairs Unit: Nearly half of study participants favor a centralized approach for their Medical Affairs organization, both in 2009 and 2012. That approach is heavily utilized by the pharma segment whereas the device segment is much more likely to use a hybrid model. Some companies are decentralizing or shifting to a hybrid model because of the varying regulatory hurdles encountered within different regions or therapeutic areas.
• Medical Affairs Reports to VPs: Three out of four mature market companies in the 2012 benchmark class report to the Vice President level or above, whereas less than 60% did so in 2009. This change was driven by an increase of 20% in Medical Affairs reporting into Senior/Executive Vice Presidents. 
  

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.