The MA competency framework is organised into six core domains: Scientific/Technical Knowledge, Evidence Generation, Compliance, Governance and Ethics, Leadership/Professionalism, Communication and Collaboration, and Business Acumen, which were developed iteratively through extensive consultation with the Australasian MA community and are designed to comprehensively cover the skills and knowledge required by MA professionals in the region. The framework is structured across four proficiency levels, from novice to expert, providing a clear pathway for skill progression within this profession.

The Australian National Medicines Policy aims to “achieve the world’s best health, social and economic outcomes for all Australians, through a highly supportive Medicines Policy environment” [25]. The central pillars, principles and enablers of the policy align closely with the key domains of competence set out in the MAPA MA competency framework, highlighting its relevance to delivering on the National policy aspirations.

While this framework is not explicitly structured around categories such as ‘core,’ ‘functional,’ and ‘meta’ competencies, it inherently incorporates meta-competencies—those higher-order capabilities that enable professionals to effectively acquire, adapt and integrate other competencies over time. Meta-competencies such as learning agility, critical thinking, ethical reasoning, strategic thinking, interpersonal adaptability and systems thinking are embedded across the domains (e.g., learning agility in scientific/technical and leadership domains; critical thinking in evidence generation; ethical reasoning in compliance; strategic thinking and self-awareness in leadership; interpersonal adaptability in communication; systems thinking in business acumen). Such integration aligns with established competency-based education approaches—for instance, IFAPP’s model emphasises the progression of integrated abilities comprising knowledge, skills, values and attitudes adapted to evolving professional contexts [6, 26]. By embedding meta-competencies, the framework ensures MA professionals are equipped to navigate complex, dynamic environments and respond robustly to emerging scientific, healthcare and regulatory challenges.

The competency framework was developed in the context of the Australian MAPA member consultations and discussions, although many of the contributors have had international experience, and the Amgen experience has demonstrated the utility of this framework in the region (Australia, China and Japan; see the companion paper by [24] in this journal). This points to the possibility of our framework having broader applicability than just the Australasian region and further testing by individuals and companies may solidify its broader applicability across MA professionals. This provides an opportunity to support and raise the standards of MA professionals across our region to support research, registration, funding and patient care more broadly. The different local environments may require differing levels of competence in different domains, but all remain relevant.

Other international jurisdictions have implemented higher medical training for medically qualified MA professionals, which incorporates the attainment of the Diploma of Pharmaceutical Medicine (or similar), and several years of workplace demonstration of competence under the guidance of a named higher training supervisor. This training has given employers and others confidence in the ability of individuals and companies when making decisions for where to place research or who ought to be hired for roles.

As noted by Stonier and Jones (2025) and Silva et al (2025), the shift from informal on-the-job learning to structured, nationally accredited programmes have created clear expectations for scientific, regulatory and leadership competencies [12, 27]. These models—such as those promoted by the PharmaTrain syllabus—offer useful precedents for MA, particularly given the discipline’s expanding remit and its interdisciplinary positioning at the intersection of science, policy and strategy.

Within the Australian context and to support international investment, the development of independent assessment of competence would provide similar reassurance that the personnel trained here are competent and able to take on board the development, registration and reimbursement of medicines. Additionally, local companies and recruitment agencies, when adopting the framework, would be able to articulate in a more consistent manner the competencies required for a role. The University of Sydney has already begun to create a suite of independent courses to support and certify attainment of competency across all domains and levels. Other private providers are likely to also develop similar programmes, and these will complement internal training opportunities that companies already provide. Companies committing to support their employees to progress their competencies through the framework will be at a competitive advantage for recruitment and retention of staff. In addition, where there is currently no alignment between organisations for the competencies required for a role which may have the same job title, a framework to standardise what would be expected or could be learned in a role provides greater clarity for job description composition, applications and salary benchmarking.

This structured competency framework provides a foundation for career development and professional standardisation in MA. As the field continues to evolve, this framework ensures that professionals remain aligned with industry best practices while enhancing their impact on patient outcomes/Quality Use of Medicine and healthcare decision making. Furthermore, by integrating competency assessments with training initiatives, the framework supports lifelong learning and continuous improvement in MA functions [26].

It is intended that this framework provide a basis for individualised assessment and tailoring of training and development plans for individuals in the medical affairs profession [21,22,23]. It aligns with MAPA’s commitment to high standards for the MA profession and to further building recognition and trust (Fig. 1). Development of a recognised competency framework, assessment of an individual’s performance against that framework and alignment of development programmes with the framework may lead to formal accreditation, professional registration, recognition and enhanced trust in a profession as it develops and matures, as depicted in Fig. 1.

Competency frameworks as a step toward professional recognition and trust. Assessments against an aligned set of competencies can support effective individualised development planning, including formal training tailored to identified opportunities. Over time it is envisaged that formal accreditation could recognise attainment and contribute to obtention and/or maintenance of professional registration. Ultimately formal processes of this nature are envisioned as supporting trust for the profession and the industry

It is acknowledged that the Medical Affairs environment will continue to evolve with political, budgetary, technological and other factors driving change. Thus, we propose the framework undergoes a 3-year review cycle, updating as necessary. The process for this will follow the original development process to continue to obtain feedback across the MAPA membership, representing medicines, devices and other research organisations to cover the breadth of experience and emerging influences. Future studies will assess long-term adoption, competency progression and its influence on career advancement within the MA ecosystem.

We acknowledge the dynamic environment in which MA is evolving and that the framework is a ‘living document’ that will change as the MA profession matures. As such, the framework was developed and endorsed for a 3-year period and future reviews will incorporate ongoing feedback from the MAPA membership and broader stakeholders across the therapeutic development ecosystem in Australasia. Future research will evaluate long-term adoption of the framework, its impact on career advancement and its support for further professionalising the sector through formal education, training and accreditation. We expect that further testing across multiple geographies will help validate the framework’s general applicability.