Medical writing competencies

The knowledge, skills and aptitudes medical writing needs

3 min read

Medical writing competence combines bodies of knowledge, practical skills and aptitudes suited to the work. An explicit inventory helps employers and writers identify what the job requires and where further learning is needed.

The purpose of an inventory

The profession should itemise its knowledge and skills to support competence assessment, better hiring, self-assessment and relevant professional education. On-the-job training can be highly specialised, unsystematic and inconsistent; professional development depends on recognising what is known, what is missing and where to acquire it. Information about these requirements and learning opportunities should be available to current and prospective writers and to employers.

Identifying the specialised knowledge and skills needed to do the work should improve recruitment and training, raise professional expectations and improve retention. Mismatches between a job’s demands and an individual’s strengths and preferences may also contribute to turnover, so identifying relevant personality and cognitive traits may help recruitment, retention and training.

Knowledge and skills used in practice

An AMWA assessment reported in 2016 used interviews with 23 hiring managers to examine the knowledge, skills and abilities used by their medical writers and the need for further education. The assessment aimed to identify evidence-based educational topics for communicators with at least six years of experience. Managers worked in four settings: pharmaceutical, device and biotechnology companies preparing regulatory documents; contract research organisations preparing regulatory documents; pharmaceutical companies preparing non-regulatory documents; and medical communications companies preparing non-regulatory documents.

Five domains framed the assessment.

DomainKnowledge, skills and abilities
GatheringDetermining the document’s purpose, target audience and output type.
EvaluatingCritically reviewing, fact-checking and identifying inconsistencies in gathered information.
OrganisingOutlining, using templates and identifying references.
InterpretingUnderstanding content and deriving key messages, implications and clinical relevance.
PresentingWriting to standardised formats, guidelines and ethical standards.

Managers rated all five domains as frequently used: mean scores ranged from 4.3 to 4.8 on a five-point scale, where 1 meant no use and 5 meant daily use. Mean educational-need scores ranged from 2.6 to 2.9, indicating moderate need, on a five-point scale where 1 meant no need and 5 meant very strong need. Responses did not differ substantially among settings or between regulatory and non-regulatory work.

When asked for topics within the domain they rated highest for educational need, multiple managers named the following areas.

  • Critical thinking: interpreting rather than repeating information and building logical, fact-based arguments.
  • Soft skills: teamwork, negotiating timelines and content, resolving conflict, working with higher-ranking colleagues, and tracking and managing time.
  • Guidelines: keeping current with standards, best practices, consensus statements and templates.
  • Statistics: understanding basic and advanced statistics and communicating their meaning, including study power.
  • Tables and graphs: using modern infographics and deciding whether a visual is the best way to convey the information.
  • Pharmacokinetics: particularly in study design.
  • Technology: new software, such as the latest word-processing software.

Skills beyond writing, such as data analysis, social media management, graphics and artwork, can be an advantage. Varied backgrounds and interests can support projects whose outputs include manuscripts, digital content, infographics, videos and interviews, with a need for more than writing alone. Writers should contribute these additional skills while continuing to develop their medical writing qualifications.

Aptitudes and attentional focus

Matching attentional strengths to job requirements may be useful. Attention Control Training proposes four combinations of internal or external focus and broad or narrow attention.

AttentionInternal focusExternal focus
BroadAttention spans a range of possible thoughts. Writing requires integrating sources without external distraction or a narrow perspective.Attention spans the environment. Teaching requires awareness of the whole class without becoming absorbed in one student or in personal reflection.
NarrowAttention follows one line of thought. Statistical reasoning requires freedom from internal and external distraction.Attention concentrates on one part of the environment. Proofreading requires focus on the text without distraction or reading meaning into it.

Most people have skills in all four areas but perform better in some than others.

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