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. 2025 Sep 27.
doi: 10.1007/s40290-025-00585-8. Online ahead of print.

Development of a Competency Framework for Medical Affairs Professionals in Australasia

Andrew Weekes  1   2 , Matthew Britland  3   4 , Cathey Saha  5 , Simon McErlane  6 , Niloufar Ansari  7 , Daniel Thurley  8   9 , Victoria Elegant  10   11 , Orin Chisholm  12   12
Affiliations

Development of a Competency Framework for Medical Affairs Professionals in Australasia

Andrew Weekes et al. Pharmaceut Med. .

Abstract

Background and objectives: Medical Affairs (MA) plays a critical role in bridging the gap between research, clinical practice and business strategy. With the rapid growth in this field, it is essential to have a competency framework to support individuals' professional development. A well-defined competency framework will not only empower MA professionals to excel and develop in their roles but also contribute to better patient outcomes and improved stakeholder engagement. This paper discusses the development of a competency framework for Medical Affairs professionals in Australasia.

Methods: The MA competency framework was developed using an iterative method by a team of MA professionals across Australia through a series of workshops and surveys over 2 years with the cooperation of the local MA community. The core development team debated and finessed the final framework over this time via meetings and discussions to arrive at the draft framework. This was pilot tested by a local pharmaceutical organisation and feedback informed some minor changes to the final framework. This was then endorsed by the Medical Affairs of Australasia (MAPA) Executive Committee.

Results: The framework consists of six domains: Scientific/Technical Knowledge, Evidence Generation, Compliance, Governance and Ethics, Leadership/Professionalism, Communication and Collaboration and Business Acumen, each with specific competencies and across four clearly defined levels from novice to expert.

Conclusion: This framework has been endorsed by the Medical Affairs Professionals of Australasia Executive Committee and provides a clear framework for the professional development of medical affairs professionals across our region. It is also applicable to MA professionals more broadly.

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Conflict of interest statement

Declarations. Conflicts of Interest: OC is an employee of the University of Sydney and was previously an employee of UNSW and has an adjunct appointment at UNSW; MB is a higher degree research student at UNSW and Medical Director at Medwise Consulting. CS is a current employee of AbbVie. AW is a freelance consultant, Non-executive Director of Faciobiotherapies and was previously an employee of Servier, Abbott, AbbVie, GSK, Gilead Sciences and Bayer. SM is the Medical Director of Amicus Therapeutics Pty Ltd. NA is an employee of Amgen. DT is an employee of the University of Sydney and a director of Axis Health Co Pty Ltd. He was previously Head of APAC information and Technology at Roche. VE is an affiliate of the University of Sydney and Chief Medical Officer at Qbiotics. She was previously an employee at Amgen. Views of all authors are their own and do not necessarily reflect those of their organisations. Availability of Data and Material: Data sharing not applicable to this article as no datasets were generated or analysed during the current study. Ethics Approval: Not a clinical trial. Consent to Participate: Not a clinical trial. Consent for Publication: Not a clinical trial. Code Availability: Not applicable. Author Contributions: AW, OC, MB and CS wrote the manuscript. All authors have reviewed, edited and approved the final submitted manuscript and agree to be accountable for the work. We acknowledge the assistance of ChatGPT for editing of the final manuscript.

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