Putting a competency model to work in a writing group
A competency model can turn a writing group's expectations into role descriptions, hiring assessments, assignments and development plans. It also provides a basis for explaining responsibilities within and beyond the team.
Uses across the employee lifecycle
The DIA medical-writing model's proposed organisational uses include structure, recruiting and hiring, onboarding, training and development, setting expectations and aligning assignments, performance evaluation and retention, and defining the profession. Managers can create or revise job descriptions, develop applicant screening tools and set goals that explain how writers will be measured in development plans. Writers can self-assess against the same expectations before manager discussions and performance reviews.
In 2019, a pharmaceutical medical-writing leader reported a perceived increase in organisations adopting competency guides to standardise skill expectations, hiring and evaluation criteria, and career-development training. That account concerned a model first published in 2011 and updated in 2017.
Role descriptions and titles
A model-based advertisement can specify functions beyond document preparation, such as strategic communications and client management; activities such as data interpretation, negotiation and project management; and knowledge of guidelines, drug development and statistics. The competencies selected should fit the role: a group lead needs competencies beyond those required for document writing. Naming alliance and project management as core group-lead skills can discourage applications from writers who want only document preparation, aligning applicant and employer expectations earlier in recruitment.
Titles do not reliably map between writing groups: Writer and Group Lead may correspond to Medical Writer I and II, or both may sit at Medical Writer III with different responsibilities. A Writer may perform writing tasks for specific documents, a Lead Writer may coordinate document activities within a cross-functional group, and a Group Lead may plan writing across a drug-development programme. The competency model allows an organisation to define its title structure and align each role's skills with its work.
Applicant assessment
A competency checklist can supplement a CV and writing test and should use generic language rather than company jargon. Applicants score each competency on a scale such as 0–5, or 0–6 when a neutral option is wanted, rather than simply answering yes or no. The rationale is that someone who performed a task once might answer yes while their actual experience merits only one out of five.
Interviewers can target important areas and test the accuracy and integrity of self-assessment. An applicant rating protocol development five out of five can be asked how many protocols they wrote and what part they actually played. Questions should establish demonstrated capability on the competencies the role needs and the applicant's proficiency: novice, beginner, practitioner, knowledgeable practitioner or expert.
Career paths, assignments and development
The model can support career paths and a technical ladder. One example distinguishes three levels through their work.
| Role | Example responsibility |
|---|---|
| Medical Writer | Write documents within a team. |
| Senior Medical Writer | Evaluate, analyse and interpret medical literature with minimal supervision. |
| Principal Medical Writer | Lead medical writing for submission-related documents. |
Assignments based on writers' competencies and interests, access to training and resources, and knowledge-sharing arrangements can support retention. A maintained list of internal subject experts lets a writer needing help with protocols, for example, find a colleague with that expertise.
Cross-functional and vendor responsibilities
Defining roles against competencies also helps explain the medical writer's responsibilities to cross-functional partners in drug development. A RACI matrix—responsible, accountable, consulted and informed—can map the roles needed for a project, task or deliverable, including core, extended and ad hoc team members. The matrix can also inform contracts and operational guides with outsourcing vendors.