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Benchmarking the Pharma Industry%s Medical Affairs Functions

  • July 2014
  • -
  • Industry Standard Research
  • -
  • 63 pages

Medical Affairs, as a function, sits at a crossroads in the pharmaceutical industry. The department is expected to act as a bridge between the commercial and scientific arms of an organization. Medical Affairs is further tasked with being the conduit of information between the company and external stakeholders, bringing efficacy and safety data to the medical community as well as gathering insights from the medical community to share internally. All responsibilities must be undertaken while keeping in mind strict regulatory controls and ensuring that medical data are interpreted appropriately.

ISR has designed this report to be used as a benchmarking tool for companies to compare their Medical Affairs functions to those of Top 50 pharmaceutical organizations.

Report Overview

Medical Affairs, as a function, sits at a crossroads in the pharmaceutical industry. The department is expected to act as a bridge between the commercial and scientific arms of an organization. Medical Affairs is further tasked with being the conduit of information between the company and external stakeholders, bringing efficacy and safety data to the medical community as well as gathering insights from the medical community to share internally. All responsibilities must be undertaken while keeping in mind strict regulatory controls and ensuring that medical data are interpreted appropriately. ISR has designed this report to be used as a benchmarking tool for companies to compare their Medical Affairs functions to those of Top 50 pharmaceutical organizations.

What you will learn in this report:

• Medical Affairs department operations and structuring, including: • Division of work for both global and regional medical affairs • Department structure and unique department structures within companies interviewed • Organizational alignment and comparison of Medical Affairs placement • Outsourcing behavior: services outsourced, vendor selection, reasons for outsourcing • Size and source of Medical Affairs budget • Future predictions for the department • Qualities of successful Medical Affairs employees • Medical Affairs goals and clinical trial involvement • Best practices for: • Hiring • Clinical trial involvement • Global and regional communication • Department structure and function

How you can use this report:

• Determine where your company’s approach to Medical Affairs may be different from a typical industry approach and the benefits and drawbacks that may result. • Gather information on unique Medical Affairs structures or philosophies employed by other organizations to provide a new perspective from which to consider your company’s philosophies. • Benchmark your company’s metrics for the size of the Medical Affairs department and budget against those of other companies.

Table Of Contents

Benchmarking the Pharma Industry%s Medical Affairs Functions
Table of Contents

.2
Copyright and Usage Guidelines ..4
Methodology ...5
Respondents' Company Size ..5
Interviewee Titles ..5
Interviewee Responsibilities .6
Introduction .8
Understanding the Medical Affairs Function ...9
Medical Affairs Employees .10
Educational Background 10
Employee Qualities 11
Specific Qualities of Medical Affairs Employees 11
Key Takeaways ...12
Medical Affairs Goals and Involvement .13
Medical Affairs Goals .13
Top Medical Affairs Goals ..13
Goals Related to the Company ..13
Goals Related to Product Stakeholders .14
Goals Related to Patients ..14
Clinical Trial Involvement ..16
Actual vs. Desired Medical Affairs Involvement Timeline .17
Barrier to Earlier Involvement ...17
Key Takeaways ...19
Medical Affairs Department Benchmarking ..20
Division of Work .21
Global Medical Affairs vs. Regional Medical Affairs ...21
Global Medical Affairs ...21
Regional Medical Affairs 21
Deviations from Typical Work Flow ...22
Best Practices for Collaborating on Medical Affairs Work .23
Key Takeaways ...24
Department Structure 26
Common Medical Affairs Global Structure 26
Medical Strategy and Department Leadership ..27
Specialized Functions .28
Unique Global Medical Affairs Structures ..29
Portfolio Team ...29
Patient Focused Teams ..30
Checks and Balances ..31
Regional Structures 32
Headcount .33
Number of Worldwide Medical Affairs Employees ...33
Key Takeaways ...34
Organizational Alignment ..35
Research and Development ..35
Executive Leadership .36
Business Development ..36
Commercial ...37
Comparison of Medical Affairs Placements ..39
Key Takeaways ..40
Outsourcing Behavior 41
Services Outsourced ..41
Is Department Size a Factor? .42
Reasons for Outsourcing ...43
Limited Resources .43
Strategic Decision ..43
Vendor Selection ...44
Process for Selecting Vendors ...44
Vendor Attributes ..45
Work-Related Attributes Mentioned Most Often ..45
Customer Experience Attributes Mentioned Most Often ..46
Key Takeaways ...48
Medical Affairs Budget ...49
Size of Budget .49
Changes to the Medical Affairs Budget ..50
Source of the Budget .51
Insufficient Budget .52
Key Takeaways ...53
Challenges ..54
Demonstrating Value of Medical Affairs 54
Effectiveness Metrics .54
Compliance 54
Talent Management ..55
Establishing Medical Affairs Planning Process ...55
Access to the Medical Community .56
Key Takeaways ...57
Future Predictions ..58
Increased Sophistication 58
Patient Focus ..58
Increased Prominence ...59
Best Practices and Recommendations ...60
About Industry Standard Research 63

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