Where the competency model stops
A pharmaceutical medical-writing competency model needs to be adapted to the writer’s role and setting. Its coverage has limits, and its ability to define a profession depends on professional agreement and use.
Variation between roles
The importance of a competency varies with work environment, document type, development phase, business area and functional structure. Relevant distinctions include pharmaceutical employment versus freelancing, publication versus regulatory documents, phase I versus phase IV development, clinical work versus health outcomes, and therapeutic-area versus cross-therapeutic structures.
Detailed therapeutic-area knowledge may matter less when clinical scientists drive that content. Project management matters to all medical writers, but more to those overseeing many outsourced projects. Writers should focus on applicable elements and adjust the model to their circumstances.
Gaps in coverage
The industry model described in 2011 covered core pharmaceutical medical-writing competency across work environments, but not the competencies needed to run a freelance business. Its pharmaceutical focus left publishing, continuing medical education, patient education and academic writing less well represented.
The model is not company-specific, while role expectations differ substantially between jobs and companies. Overall competency should therefore be examined with additional tools, with the model adjusted to the situation.
No writer can be fully competent in every area the model covers, so overdependence on it should be avoided. Flexibility is also needed because role expectations change with technology, regulation, globalisation, work environment, industry dynamics and partnerships.
Limits to defining a profession
Whether medical writing constitutes a distinct discipline, and how medical communication is defined, present difficulties for a competency model. Choosing core competencies and setting their priorities are further challenges: medical writing may be too broad for one model to define the profession, and individual niches may need separate models.
A model can become a professional standard only if practitioners use it, believe in it, contribute to its development, agree on its content and demonstrate its competencies; without uptake, it defines nothing. Competencies defined by practitioners who understand the work can help define the discipline, and medical-writing professionals should ensure that those using the title meet its disciplinary standards.
A model for continuing medical education
In early 2023, continuing medical education (CME) writers lacked a competency model or training outline comparable to those available for regulatory writers. Medical-education company executives reported anecdotally that a model would help address a shortage of qualified CME writers, and clinicians entering the field expressed interest in specialised training.
A project then underway had two goals.
- Identify the knowledge areas, skills and attitudes the next generation of CME writers needed to excel.
- Identify the deliverables those writers should be able to develop.
The project used a Delphi panel of 22 experts, balanced among writers, teachers and company executives. The process called for three questionnaire rounds in which panel members would rate preliminary competencies and suggest additions across knowledge areas, skills, attitudes and deliverables (KSADs). Each successive round was to provide controlled feedback through ratings and their rationales, with identities protected during deliberations and members free to revise their ratings in response to others’ reasoning. A predefined group rating of at least four out of five indicated consensus for inclusion, and statistical analysis was planned to examine stability between rounds and differences between subgroups.
Later in 2023, a first competency model for writers developing continuing education in the health professions was still in development, with presentation planned for that year’s Medical Writing & Communication Conference in Baltimore.