Medical Affairs : The Roles, Value and Practice of Medical Affairs in the Biopharmaceutical and Medical Technology Industries

Medical Affairs is one of the three strategic pillars of the pharmaceutical and MedTech industries, but while clear career paths exist for Commercial and Research and Development, there is no formal training structure for Medical Affairs professionals. Medical and scientific expertise is a prerequisite for entry into the function, and many people transitioning into Medical Affairs have advanced degrees such as PhD, MD, or PharmD. However, these clinical/scientific experts may not be especially well-versed in aspects of industry such as the drug development lifecycle, crossfunctional collaborations within industry, and digital tools that are transforming the ways Medical Affairs generates and disseminates knowledge. This primer for aspiring and early-career Medical Affairs professionals equips readers with the baseline skills and understanding to excel across roles. Features: Defines the purpose and value of Medical Affairs and provides clear career paths for scientific experts seeking their place within the pharmaceutical and MedTech industries. Provides guidance and baseline competencies for roles within Medical Affairs including Medical Communications, Evidence Generation, Field Medical, Compliance, and many others. Specifies the "true north" of the Medical Affairs profession as ensuring patients receive maximum benefit from industry innovations including drugs, diagnostics and devices. Presents the purpose and specific roles of Medical Affairs roles across organization types including biotechs, small/medium/large pharma and device/diagnostic companies, taking into account adjustments in the practice of Medical Affairs to meet the needs of developing fields such as rare disease and gene therapy. Leverages the expertise of over 60 Medical Affairs leaders across companies, representing the first unified, global understanding of the Medical Affairs profession. Cover Half Title Title Page Copyright Page Table of Contents Preface About the Editors List of Contributors Section 1 Medical Affairs in the Pharmaceutical and MedTech Industries Chapter 1 What Is Medical Affairs? Chapter 2 Groups and Structure of Medical Affairs Chapter 3 Medical Affairs Collaborations Across the Drug/Device Development Lifecycle Chapter 4 Measuring the Impact of Medical Affairs Chapter 5 Medical Affairs Careers Section 2 The Practice of Medical Affairs Chapter 6 Medical Strategy and Launch Excellence Chapter 7 Evidence Generation and Real-World Evidence Chapter 8 Medical Communications Chapter 9 External Education Chapter 10 Field Medical Chapter 11 Insights Chapter 12 Medical Information Chapter 13 Patient Centricity Chapter 14 Medical Operations Chapter 15 Digital Strategy Chapter 16 Compliance Chapter 17 Rare Disease and Gene Therapy Chapter 18 Medical Affairs in MedTech Index Medical affairs is one of the three strategic pillars of the pharmaceutical and medtech industries, but while clear career paths exist for commercial and research & development, there is no formal training structure for medical affairs professionals. Medical and scientific expertise is a prerequisite for entry into the function and many people transitioning into medical affairs have advanced degrees such as PhD, MD or PharmD. However, these clinical/scientific experts often lack knowledge and training in areas such as the drug development lifecycle. This primer for aspiring and early-career medical affairs professionals, equips readers with the baseline skills to excel across the roles.