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.
- 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.
SECTION 1: MEDICAL AFFAIRS IN THE PHARMACEUTICAL AND MEDTECH INDUSTRIES
Chapter 1 What Is Medical Affairs?
Kirk Shepard, Charlotte Kremer, Robin Winter-Sperry, Danie du Plessis and Peter Piliero
Chapter 2 Groups and Structure of Medical Affairs
Victoria Elegant, Greta James-Chatgilaou, Darryl Sleep and Bagrat Lalayan
Chapter 3 Medical Affairs Collaborations Across the Drug/Device Development Lifecycle
Tamas Koncz, Gail Cawkwell and Liviu Niculescu
Chapter 4 Measuring the Impact of Medical Affairs
Anna Walz, Paul Tebbey, Jovanka Paunovich and Joe Kohles
Chapter 5 Medical Affairs Careers
Peter Piliero, Jim Alexander, Danny McBryan, Patrick Reilly, Wendy Fraser and Charlotte Raabe-Hielscher
SECTION 2: THE PRACTICE OF MEDICAL AFFAIRS
Chapter 6 Medical Strategy and Launch Excellence
Meg Heim, Rachele Berria, Loubna Bouarfa, Deb Braccia, Shontelle Dodson, Andrew Greenspan, Deborah Long, Ameet Nathwani, Tam Nguyen, Holly Schachner, Roz Schneider, Ajay Tiku, Rebecca Goldstein and Stephanie Wei
Chapter 7 Evidence Generation and Real-World Evidence
Ann Hartry, Charlotte Kremer, Judith Nelissen, Omar Dabbous, Suzanne Giordano and Kristine Healey
Chapter 8 Medical Communications
Renu Juneja, Rob Mattheis, Sandrine Jabouin and Noreen Hussein
Chapter 9 External Education
Shontelle Dodson, Kirtida Pandya, Marleen van der Voort, Maureen Doyle-Scharff and Kimberly Braithwaite
Chapter 10 Field Medical
Robin Winter-Sperry, Kathy Gann, Suzanne Giordano, Lori Mouser and Rich Swank
Chapter 11 Insights
Sandra Silvestri, Siobhan Mitchell, Dr Mónica de Abadal, Catrinel Galateanu and Monique Furlan
Chapter 12 Medical Information
Evelyn R. Hermes-DeSantis, Stacey Fung, Kristin Goettner, Christopher J. Keenan, Marie-Ange Noue and Jill Voss
Chapter 13 Patient Centricity
Danie du Plessis, Oleks Gorbenko, Isabelle Bocher-Pianka, Tricia Gooljarsingh, Karen King and Roslyn F. Schneider
Chapter 14 Medical Operations
Suzana Giffin, Bjorn Oddens, George Betts, Søren Buur, Arnaud Gatignol and Sokhon Bouy
Chapter 15 Digital Strategy
Rishi Ohri, Sarah Clark and Richard Kemper
Chapter 16 Compliance
Maureen J. Lloyd and Jessica Santos
Chapter 17 Rare Disease & Gene Therapy
Nikolai Nikolov, Leonard A Valentino and Tricia Gooljarsingh
Chapter 18 Medical Affairs in MedTech
William Sigmund, John Pracyk, Tobi Karchmer, Joao D. Dias, Klaus Hoerauf, Idal Beer, David Macarios, Bill Altonaga, Greg Christopherson, Ann Ford, Dee Khuntia, Sean Lilienfeld, Mark Miller, Hany Moselhi, Ross "Rusty" Segan and Ronald Silverman