About This Standards & Guidance

This resource, created with senior Medical Operations professionals, offers guidance and recommendations for the development of Medical Operations. It serves as a foundational document and may not cover all unique situations or specific organizational requirements.

In this Standards & Guidance you will learn:

This resource is intended to provide Medical Affairs teams the rationale for meaningful value and impact measurements, as well as tips to support these:

  • What is Medical Operations and why is it important?
  • What are the specific responsibilities of Medical Operations across key Medical Affairs workstreams?
  • How should Medical Operations be designed to optimize its value and perform at its best?
  • How will Medical Operations need to change in the context of the wider evolution of Medical Affairs?
  • What additional tools and resources are available to support those working in Medical Operations?

MAPS would like to thank the following authors:

Brian Bowmil

Brian Bowmil

Daiichi Sankyo
Kat Long

Kat Long

Mural Oncology
Melissa Toler

Melissa Toler

Harmony Biosciences
Rachel Hatfield

Rachel Hatfield

Managing Partner, MEDiSTRAVA Consulting