Charged with building and maintaining physician relationships, pharmaceutical Medical Affairs organizations typically oversee several important functions -- including publications, KOL programs, grants and medical education (CME) -- that have been impacted in recent years by a call for increased transparency. As such, forward-looking biopharmaceutical executives are evaluating Medical Affairs operations to ensure it is appropriately structured and resourced to operate effectively in the current environment.
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 recent trends in budget and staffing resources, key challenges and top success factors for 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.
Key Topics
Organizational Structure
Reporting Relationship
Job Level of Group Leader
Geographic Span
Budget Allocation by Medical Affairs Function
Percent of Budget Allocated for Outsourcing
Recent and Anticipated Changes in Resource Levels
Impact of Medical Affairs Functions on Company Success
Key Success Factors for Medical Affairs
Key Challenges for Medical Affairs
Appendix
Key Metrics
Type of structure (centralization)
Medical Affairs group dedication
Departmental reporting relationships
Job level or Medical Affairs head
Geographic span of organization
Percentage of spending per Medical Affairs function
Directional trends in Medical Affairs funding levels
Directional trends in staffing levels
Reasons cited for budget/staff increases
Reasons cited for budget/staff decreases
Relative importance of seven different Medical Affairs functions
Reasons cited for increased importance
Reasons cited for decreased importance
Percentage of budget allocated for outsourcing
Percent of companies impacted by FDA Revitalization Act
Top three success factors for developing and maintaining effective Medical Afffairs group
Top three challenges for developing and maintaining effective Medical Afffairs group
Sample Key Findings
1. Structure: The Medical Affairs organization is most often a centralized, dedicated group with a global geographic span that includes the U.S. Typically, Medical Affairs organizations report to the Executive Team (42 percent) rather than to Marketing or R&D. The head of Medical Affairs holds the job level of vice president or above at a majority of companies (54 percent.)
2. Spending: On average, 37 percent of Medical Affairs spending is allocated for medical/clinical research operations, with the top quartile spending more than 60 percent for the clinical function. Medical Educations takes up about 18 percent of Medical Affairs allocations.
Methodology
Twenty-six Medical Affairs leaders at 25 pharmaceutical companies participated in this benchmarking research project.
BENCHMARK CLASS
Industries Profiled:
Biotech; Pharmaceutical; Manufacturing; Consumer Products; Diagnostic; Medical Device; Chemical; Health Care
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