The global market and its standards
Medical writing crosses national borders through its workforce, clients, documents and readers. A global market creates a shared interest in the profession’s training, ethics and standards.
Market growth and professional reach
In 2009, market research suggested that the global medical-writing market had apparently doubled over the preceding five years and that about 40% of clients outsourced medical writing. Global expansion increased the risk of writers lacking appropriate training and ethical standards, because poorly trained writers anywhere could affect respect for the whole profession.
Association membership understates the size of the workforce: writers also belong to other organisations, and some people doing the work do not recognise themselves as medical writers because their job titles differ. These include writers in small biotechnology companies, health journalists and people working within health systems. Reaching these writers matters because their work intersects with that of the recognised profession.
In 2019, EMWA had approximately 1,100 members and AMWA more than 4,000, together spanning 58 distinct countries; the Australasian Medical Writers Association had approximately 300 and the International Society for Medical Publication Professionals more than 1,500. By December 2024, EMWA had more than 1,500 members in 50 countries, covering every continent except Antarctica.
The work itself has global reach: manuscripts are read internationally, and drugs and therapies supported through regulatory writing benefit patients around the world. Digital and virtual systems connect writers despite their geographical spread.
A globally distributed workforce
The COVID pandemic increased opportunities to work on global medical-writing teams regardless of location, while remote collaboration, inclusion, transparency and demand for speed and quality brought global working into sharper focus.
In 2022, global capability centres were described as becoming the norm, with round-the-clock continuity, access to worldwide talent and resilient, agile capabilities identified as advantages of a global workforce. Companies whose writing operations were already distributed globally reportedly experienced minimal disruption during the pandemic. Building such a workforce requires shared job descriptions, standard hiring methods, common training and upskilling, and uniform performance and conduct standards.
Professional writing associations have offered training and networking with a predominantly regional presence, while virtual conferences and training have shown how expertise can become more accessible globally. A global professional community would allow writers to develop common skills across geographical boundaries.
Standards shared across borders
Regulatory writing has been proposed as sufficiently distinct from other medical writing to benefit from its own global standards and development programmes. Harmonised position profiles across pharmaceutical companies and clinical research organisations could define core capabilities and responsibilities more consistently.
Harmonising document templates and guidance could let writers use their knowledge more easily across regions, open geographical career opportunities and help attract and retain scarce talent. Shared training and educational aims could support certification with meaningful outcomes and measurements, allowing writers to develop without relying solely on an individual company’s training commitment and expertise. A 2022 forecast anticipated more certification or training programmes to demonstrate a base skill set as the work became more complex.