What regulators and regulatory writers say the writing is worth
Surveys of regulatory reviewers and writers describe the value they see in medical writing, the document problems that matter to reviewers and the contributions for which writers feel recognised.
The need for evidence
At the November 2019 AMWA Medical Writing Executives Forum, executives agreed that writing teams needed hard evidence of their value, while the variety of settings and documents made indicators difficult to identify. Regulatory writers employed by biopharmaceutical companies reported feeling highly valued, while writers in other departments and in consulting firms or contract research organisations did not share that perception.
AMWA established a working group in 2020 to define and quantify regulatory writers’ value, including writers’ and employers’ perceptions, regulatory agencies’ views and other topics bearing on value. Writing departments can lack resources because the role is not understood, and writers still have to justify joining teams early.
Reviewers’ experience of document quality
The regulatory survey ran from April to early August 2021 among active agency document reviewers, their managers and people who had held a review role in the previous six months. Recruitment used professional contacts and onward invitations, and anonymity means the agencies actually represented are unknown. There were 32 respondents, with varying numbers answering individual questions; most had worked at their agency for over five years and spent at least 10% of their time reviewing documents. The small sample supported descriptive analysis only.
Poor quality impeded regulatory assessment for 87% of respondents, none disagreed, and 87% reported encountering quality problems sometimes or often. Asked about the preceding five years, 43% perceived improved quality, 48% no change or no opinion and 9% declining quality; examples of quality problems had not yet been provided, so respondents used their own understanding of quality. Of those answering, 53% said they returned or rejected more than 10% of applications with questions arising from poor document quality, while 47% put the proportion below 10%. For applications ultimately approved, 77% agreed or strongly agreed that poor document quality delays approval.
Asked whether poor writing negatively influenced their review of an applicant’s other documents, 27% agreed, 27% disagreed and 45% were neutral; the question did not define what such influence meant in practice. Three respondents, 13%, said their agency collected document-quality data, 35% said it did not and 53% did not know; 90% said their agency did not record applicants who regularly submitted poor documents.
Frequency, irritation and approval
The quality questions offered these response options, in this order.
- Poor organisation.
- Poor language usage.
- Lack of clarity.
- Poorly designed or presented tables and graphs.
- Data errors, including inconsistencies and transcription errors.
- Incomplete content.
- Poor explanation of rationale.
- Excessive length, unnecessary repetition or verbosity.
- Incorrect format or nonadherence to guidance.
- Broken, incorrect or insufficient cross-links.
- Other.
- None.
When respondents could select all problems encountered, excessive length, repetition or verbosity led, followed by lack of clarity. Asked for the single most frequent problem, they placed excessive length first, poor explanation of rationale second and nonadherence to guidance third. Data errors, incomplete content, broken links and poor tables ranked relatively low, which suggested that many applicants already had processes to catch these avoidable problems.
Poor explanation of rationale caused the greatest irritation or negative effect on review, followed by excessive length. Poor rationale also ranked first for negative effects on approval, followed by incomplete content. Incomplete content was relatively infrequent but important for approval when present, whereas excessive length was frequent and irritating without ranking among the leading obstacles to approval.
What reviewers valued in writers
Among those answering, 67% knew about medical writers’ contribution, 70% agreed or strongly agreed that writers improved document quality and 87% agreed or strongly agreed that established writing functions with rigorous document-development processes and standards produced higher-quality submissions. The last question preceded the examples of quality problems, so respondents used their own concept of quality. Only 14 answered where writers added value: over 78% named adherence to standards, 71% accuracy and 64% each clarity, completeness, explanation of rationale and formatting.
Respondents who volunteered for follow-up interviews reported quality problems across document types and considered experienced writers necessary because templates and guidance could not cover every nuance. Poor rationale took time to interpret, and whether reviewers sought clarification depended on document type and safety implications, available time, complexity and access to agency specialists. Some agencies could interpret it as a lack of transparency, potentially prompting extra scrutiny throughout the application. Unclear sponsor objectives could suggest an attempt to overwhelm reviewers with data, particularly after previous difficulties with that sponsor; reluctance to supply other agencies’ meeting minutes delayed approval because reviewers needed to understand concerns in other regions.
Interviewees described writers as making documents clear, brief, consistent and usable, and said poor writing could leave them guessing at messages despite recognising good science behind the document. They associated inexperienced writing with poor attention to detail and standards, saw no negative in involving writers and reported that some agencies had their own writing teams. Writers’ involvement could nevertheless be invisible to the agency: the reviewer wanted a good document rather than to know who had written it.
Writers’ perceptions of their contribution
The anonymous writer survey reached AMWA, EMWA and DIA medical-writing communities, professional contacts and partner companies, asking whether respondents currently worked or had worked in the preceding five years as regulatory writers. There were 548 responses, of whom 522, 95.3%, confirmed current regulatory-writing employment; 488, 89.1%, were employed, 53, 9.7%, freelance or self-employed, four, 0.7%, retired or unemployed and three, 0.5%, in another category.
The 518 employer responses had this distribution.
| Employer | Number | Percent |
|---|---|---|
| Pharmaceutical company | 261 | 50.4 |
| Clinical or contract research organisation | 118 | 22.8 |
| Biotechnology company | 56 | 10.8 |
| Medical device company | 29 | 5.6 |
| Medical communication company | 23 | 4.4 |
| Full-service provider or staffing company | 15 | 2.9 |
| Other | 13 | 2.5 |
| Medical school or university | 2 | 0.4 |
| Medical marketing, advertising or public relations agency | 1 | 0.2 |
Respondents reported the following parent groups for their writing function.
| Parent group | Number | Percent |
|---|---|---|
| Standalone medical-writing group or function | 198 | 38.2 |
| Regulatory affairs | 115 | 22.2 |
| Clinical development | 68 | 13.1 |
| Clinical operations | 52 | 10.0 |
| Other | 32 | 6.2 |
| Biostatistics or biometrics | 18 | 3.5 |
| Not applicable | 16 | 3.1 |
| Medical affairs | 11 | 2.1 |
| Strategic operations | 4 | 0.8 |
| Pharmacovigilance | 2 | 0.4 |
| Quality | 2 | 0.4 |
The high standalone share differed from the working group’s experience and might reflect ambiguity in the question or the inclusion of smaller companies and research organisations. Among 444 answering about experience, 54.5% had over ten years, 18.9% six to ten, 20.5% two to five and 6.1% under two years. Among 444 answering about education, 46.4% held a PhD, 6.1% another advanced degree, 33.1% a master’s, 12.5% a bachelor’s and 1.8% another qualification. Among 440 answering about gender, 75% identified as women, 18.9% as men and 6.1% preferred not to say. The low share of junior writers might reflect slow recruitment or failure to reach them; the survey did not establish which explanation applied.
The roles selected were document preparation using templates and guidance, 27.6%; that work plus strategic guidance, 25.2%; both plus managing submission documents and routinely leading Common Technical Document preparation, 34.2%; management or project management, 8.6%; and other, 4.4%. Most respondents’ work therefore extended beyond template-based document preparation.
Feeling valued and contributing value
When writers had to select one thing that made them feel most valued, they gave these responses.
| What made writers feel valued | Number | Percent |
|---|---|---|
| Consultation, opinion sought or decision-making | 154 | 30.8 |
| Contribution to patients or community | 89 | 17.8 |
| Compensation | 80 | 16.0 |
| Scientific research or developing scientific knowledge | 77 | 15.4 |
| Autonomy or flexibility | 32 | 6.4 |
| Recognition | 31 | 6.2 |
| Career progression, job title or opportunity for movement | 28 | 5.6 |
| Other | 9 | 1.8 |
Ranking the options produced the same order except that autonomy and recognition exchanged places; career progression remained last, with 4.7% ranking it first. Among 495 respondents, most felt their technical and tactical and their scientific and strategic skills were fully used. Their teams fully recognised their value and skills according to 53.5% who agreed and 21.6% who strongly agreed, compared with 9.7% disagreeing and 1.2% strongly disagreeing. Most also felt empowered by management to guide document-development processes and included in necessary meetings about strategic decisions affecting their documents.
Asked for the single area in which they added most value to document preparation, 444 writers gave these answers.
| Area | Number | Percent |
|---|---|---|
| Clarity | 196 | 44.1 |
| Organisation | 80 | 18.0 |
| Completeness | 45 | 10.1 |
| Accuracy | 44 | 9.9 |
| Adherence to standards | 44 | 9.9 |
| Explanation of rationale | 22 | 5.0 |
| Brevity | 9 | 2.0 |
| Formatting | 4 | 0.9 |
| Linking | 0 | 0.0 |
When several answers were allowed, 95.3% included clarity and 90.8% organisation. Of 102 writers adding comments, many stressed steering documents towards successful submissions, while several considered their contribution underappreciated and difficult for management to measure. One writer reported substantially improved document quality and delivery time after a writing department was established within clinical operations.
Recognition, feedback and development
Writers choosing the one skill their teams most often recognised gave this distribution.
| Skill recognised by the team | Number | Percent |
|---|---|---|
| Leadership, managing the process and maintaining timelines | 148 | 32.8 |
| Collaboration and flexibility | 116 | 25.7 |
| Strategic guidance on documents or submissions | 79 | 17.5 |
| Writing skills, including language and readability | 34 | 7.5 |
| Comment resolution and consensus | 26 | 5.8 |
| Problem-solving | 19 | 4.2 |
| Quality control and accuracy | 19 | 4.2 |
| Compliance | 5 | 1.1 |
| Study design and project decisions | 5 | 1.1 |
The top three remained the same when writers ranked recognition, with the remaining skills at least five percentage points below strategic guidance. Asked which skills teams wanted improved, writers reported these responses.
| Area for improvement | Number | Percent |
|---|---|---|
| Other | 110 | 24.4 |
| Leadership, process management and maintaining timelines | 79 | 17.5 |
| Lack of flexibility | 62 | 13.7 |
| Compliance with procedures | 61 | 13.5 |
| Comment resolution and consensus | 45 | 10.0 |
| Writing skills, including language and readability | 36 | 8.0 |
| Quality control, too many errors | 36 | 8.0 |
| Collaboration | 22 | 4.9 |
The most common entries under other were none and not applicable, without a consistent trend; ranking the improvement areas again put leadership and flexibility first. These accounts of team recognition and feedback came from writers rather than directly from teams or employers.
Asked whether employers provided sufficient training and development for success and advancement, 44.1% agreed and 29.3% strongly agreed, while 17.4% were neutral, 6.7% disagreed and 2.5% strongly disagreed. Writers’ leading desired training areas were leadership, project management and collaboration or diplomacy. The training question offered leadership skills, project management, collaboration or diplomacy, effective communication, technical or writing skills, quality control and other, in that order.
Unresolved questions and awareness
Executives discussing the surveys in 2021 identified a need for a granular, shared definition of quality, an account of its effects on return on investment in time, money and resources, and a better understanding of staff versus contract or freelance employment models.
When the regulator findings were discussed at EMWA and AMWA roundtables in May and November 2022, only two of approximately twenty participating writers had previously read the survey article. Participants agreed that people using resources based on the findings needed to understand the survey and its results.