Medical Writing 2026: Adapting to AI and Rising Complexity

Will we all have a job this time next year?

Medical writing has traditionally been a (relatively) stable profession, positioned at the intersection of science, regulation, and communication. For decades, its core value proposition, accuracy, clarity, and regulatory compliance combined with informed application and speed, changed only incrementally despite wild shifts in therapeutic modalities and regulatory frameworks. However, multiple converging forces suggest that 2026 may represent an axis year: a pivotal moment after which the practice, economics, and professional identity of medical writing may be materially altered.

The convergence of advanced artificial intelligence (AI), intensifying financial pressure on research systems, rising regulatory complexity, and geopolitical realignment in the global biomedical landscape may reflect a perfect storm. These forces aren’t likely to affect all medical writers equally. In-house versus freelance writers, regulatory versus medical affairs writers, and those operating in academic or grant-support contexts will most likely experience divergent risks and opportunities. While AI tools promise productivity gains, the drive to reduce costs and accelerate timelines is likely to push widespread AI adoption, whether openly acknowledged or tacit, placing new pressures on quality, accountability, and professional credibility.

Defining an Axis Year

An ‘axis year’ would be defined as a point at which incremental change gives way to structural transformation. In professional domains, such periods are characterised not by a single disruptive event, but by the alignment of multiple trends that collectively shift incentives, behaviours, and norms [1]. For medical writing, several indicators suggest that 2026 could be such a threshold.

At the forefront of those changes is the advent of AI and large language models (LLMs), which have been transitioning from experimental aids to embedded infrastructure across pharmaceutical, biotech, and contract research organisations. Second, research funding, both public and private, is increasingly constrained, with heightened demands for speed, efficiency, and demonstrable return on investment. Third, regulatory agencies are simultaneously raising evidentiary expectations while experimenting with automation and digital transformation. Finally, geopolitical forces are reshaping where biomedical research is conducted and how regulatory documentation is produced and standardised. Together, these trends point toward accelerating change rather than gradual evolution.

Technological Transformation

Perhaps the most visible driver of change has been the rapid maturation of LLMs and intelligent authoring systems. Studies have demonstrated that AI tools can substantially increase drafting speed, assist with consistency checking, and support literature synthesis in biomedical contexts [2,3]. Regulatory agencies themselves are exploring AI to streamline review workflows, implicitly legitimising its use upstream in document preparation [4].

For medical writers, this creates a dual effect. Productivity expectations are rising, as tasks once requiring days may now be completed in hours. Simultaneously, the competency profile of the profession is shifting. Writers are increasingly expected to function as editors, curators, and validators of AI-generated content, rather than sole authors [5]. It feels more than coincidental that those changes are occurring at the same time as various sources talk of widespread layoffs and employment agencies report marked reductions in medical writing opportunities [6].

Corporate-based writers might be expected to experience earlier and more formalised AI adoption, supported by enterprise-level tools, governance frameworks, and legal oversight. Freelancers, by contrast, face strong incentives to adopt AI independently in order to remain price-competitive, often without institutional guidance. This asymmetry raises concerns about uneven quality standards and professional risk exposure.

Regulatory writers are under particular pressure. While AI can assist with structure, consistency, and cross-referencing, accountability for regulatory submissions remains firmly human. Errors or misinterpretations introduced through AI-assisted drafting carry significant compliance risk [7]. In contrast, medical affairs and academic support writers have been experiencing greater flexibility, with AI increasingly used for first drafts, slide development, and narrative synthesis etc.

Economic Pressures on Research and Writing

Global research funding has become increasingly competitive. In academia, grant success rates have declined in many jurisdictions, with funders prioritising translational impact and interdisciplinary work [8]. In industry, rising development costs and high late-stage failure rates have driven portfolio rationalisation and aggressive cost containment [9]. These pressures directly affect medical writing. Sponsors seek faster deliverables, leaner teams, and greater reuse of ‘boiler plate’ content across regulatory, medical affairs, and market access functions. Outsourcing has expanded, but with downward pressure on fees, particularly for freelance writers [10].

I would like to be able to say that medical writing has historically been valued as a specialist, labour-intensive service. However, writers are often viewed as junior team members and AI further destabilises the value perception by framing writing as easily automatable. The result, a growing tension between price expectations that is being shaped by automation rhetoric and risk realities that still demand expert human oversight. This tension can be expected to intensify in 2026 as budget holders push for cost savings without proportionate reductions in liability. Don’t bother raising the price, speed and quality trifecta.

Challenges in Drug and Device Development

Clinical development has grown more complex, with increasing requirements for adaptive trial designs, real-world evidence requirements, and post-approval commitments [11]. We also have more complex medical modalities, gene and cell therapies and devices. Regulatory documentation has expanded accordingly, increasing both volume and conceptual difficulty. Poorly written or incoherent submissions are increasingly recognised as contributors to regulatory delay [12]. Here, high-quality medical writing can serve either as a bottleneck or an accelerator. Competent writers who understand regulatory science, data interpretation, and narrative coherence can materially influence submission success. Conversely, over-reliance on poorly supervised AI tools risks introducing subtle inconsistencies that undermine regulatory confidence. Nevertheless, use of AI tools is becoming more common as stakeholders respond to financial targets.

Geopolitical and Policy Influences

Everyone is aware that US policy is a major source of uncertainty. Public statements by figures such as Robert F. Kennedy Jr. have raised questions about vaccine policy, regulatory independence, and trust in biomedical institutions, while a potential return to Trump-era trade and regulatory positions could affect global harmonisation efforts [13][14]. Such shifts serve to increase documentation complexity, as sponsors most service providers navigate financial challenges (and the desire for profits), divergent regulatory expectations and heightened scrutiny.

Asia’s role in biomedical research continues to expand. China, India, and Singapore have invested heavily in clinical research infrastructure, regulatory capacity, and biopharmaceutical manufacturing [15]. Medical writing services in these economic regions are less expensive and service providers are early adopters of innovative, effort-saving technologies.

This growth increases demand for globally competent medical writers who can operate across regulatory regimes and cultural contexts. At the same time, it intensifies competition, as writing services are increasingly globalised. Regulatory harmonisation initiatives such as ICH have reduced some barriers, but divergence persists, requiring nuanced and adaptable documentation strategies [16]. The question must be raised as to whether English will remain as the regulatory lingua Franca for much longer.

Workforce Considerations

In-house writers benefit from organisational services (stability, support and process) access to training, and clearer AI governance. At Niche Science & Technology Ltd. we expend considerable efforts and resource on continuous training, competencies, capabilities and growth. Freelancers enjoy flexibility but face greater exposure to pricing pressure, technological disruption, and reputational risk. By 2026, the freelance market is expected to polarise: highly specialised regulatory experts may command premiums, while generalist writing faces ‘commoditisation.’

Across roles, professional development imperatives are shifting. Digital literacy, data fluency, and ethical AI use are becoming core competencies rather than optional skills that writers may have [5]. Writers unable to demonstrate value beyond text generation risk their marginalisation.

Strategic Outlook and Predictions

Looking beyond 2026, several evidence-based predictions emerge. It is clear that, AI adoption is unavoidable, driven by cost and speed imperatives, irrespective of public acknowledgment. Second, regulatory scrutiny of AI-assisted content is likely to increase, placing greater responsibility on writers as accountable professionals. Finally, it can be argued that the perceived value of medical writing will bifurcate: commoditised tasks will be priced aggressively, while high-judgement, high-risk work will become more valued. The challenge will be for those commissioning projects to be able to tell which job is which. In this sense, 2026 may indeed mark a structural shift, not the end of medical writing, but the end of a particular conception of it as a purely artisanal craft insulated from technological and economic forces.

Conclusion

In the dark corners of the medical writing community they have started to whisper that the end of medical writing is nigh. Change in 2026 will be defined by the convergence of AI-driven automation, financial pressure on research the landscape, escalating regulatory complexity, and geopolitical realignment. While none of these forces is new in isolation, their alignment will be transformative.

The drive to save costs and deliver faster will push widespread adoption of AI tools, whether openly acknowledged or quietly embedded in workflows. This will shift greater pressure onto the medical writing community to uphold quality, accountability, and ethical standards in an environment of heightened productivity expectations. For educators, employers, and policymakers, the challenge is to recognise medical writing not as a replaceable cost centre, but as a critical function in safeguarding scientific integrity and public trust. For myself, I expect writers will still have jobs this time next year. Whether 2026 becomes a moment of professional renewal or erosion will depend on how these pressures are managed by stakeholders.

References (Vancouver style)

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