The medical writer certification
Medical Writer Certified (MWC) is the American Medical Writers Association's (AMWA's) examined credential for core medical-writing knowledge across work settings. Its development involved defining the profession's common competencies, establishing an independent certification structure and separating eligibility from examination performance.
Demand and purpose
AMWA explored certification in 1996 through a task group that surveyed three certifying organisations, but did not proceed because of legal, financial and other considerations. A new task force was appointed in 2009, and the board voted to pursue certification in spring 2010.
In the 2010 member needs assessment, 878 of the 1,339 people who answered whether competency-based certification was desirable said yes (65.6%). A critic's 2013 account used all 1,483 survey respondents as the denominator: 878 (59%) said yes and 605 (41%) said no or skipped the question; 737 (49.7%) said they would pursue certification and 746 (50.3%) said no or skipped. He noted that the difference between yes and not-yes on desirability was 273 responses, about 5% of the 5,600 members.
Among 65 respondents to a question sent to about 400 employers and recruiters, 26 supported certification and 39 did not or skipped; 22 identified certification or professional membership as the most important requirement after experience, and 31 would give extra consideration to someone passing a validated examination. The critic questioned whether these findings justified a $200,000 programme and requested publication or completion of a formal needs assessment. The commission replied that the board had allocated up to $200,000 over three years, with unused funds available for reallocation to other AMWA activities.
AMWA intended certification to define key competency areas and establish basic standards for uniform assessment, drawing on its institutional knowledge and securing a role in a potential professional benchmark. Its leadership emphasised in 2011 that the examination would not guarantee actual proficiency, skill or performance and should not be represented as doing so. The commission reiterated in 2014 that examination performance could show core knowledge, but could not by itself establish how well someone performed as a writer.
Governance and independence
The Medical Writing Certification Commission was established in 2011 to initiate, evaluate, maintain and oversee certification, including applications, examinations, recertification, appeals, policies and process improvements. In 2012 it had six members, with staggered two-year terms planned for at-large members to combine continuity with fresh perspectives.
AMWA described its 501(c)(3) status in 2011 as requiring a separate budget for examination activities and oversight by an independent council or commission, separate from its board and including people from inside and outside the association. Its education programme had to remain separate, although education could help candidates prepare or count toward recertification. In 2012, the plan was eventual commission independence; meanwhile, AMWA retained fiscal oversight, allocated separate funds, supplied staff and business support and provided access to legal advice. The commission chair also sat on AMWA's executive committee and board to facilitate communication.
By late 2013, the commission was developing its policies and procedures manual, covering responsibilities, administrative structure, possible subcommittees and examination policies. A candidate handbook would set eligibility, explain procedures and guide preparation; a repository of books, online resources and self-study modules documented the sources for test questions and could also support candidates' preparation.
Development of the examination content
AMWA contracted with Schroeder Measurement Technologies (SMT) to analyse medical-writing work, identify knowledge and practice to assess, specify examination content and support its legal defensibility. SMT reviewed curricula, job descriptions, publications, guidelines and other resources to draft knowledge, skill and ability areas. Its staff and a job-analysis panel representing key writing areas developed domains and supporting elements through two days of discussion, followed by wider vetting.
The 2012 job analysis defined medical writers broadly as people writing, editing or doing both in biomedical research, clinical care and health sciences. Respondents rated how important the proposed knowledge, skills and abilities were in their jobs, linking examination content with practice. AMWA and allied organisations alerted more than 10,000 people to the survey; after beta testing, it ran from 28 April to 8 July 2012 and received 1,177 responses, an 8% return rate that SMT described as average for an unsolicited survey. The commission planned to use these results to determine the content outline and relative weights. Subject experts would receive training in writing unambiguous, relevant questions linked to the outline, under SMT's confidentiality controls.
Early proposals included a largely multiple-choice examination, possible writing exercises or portfolio material, and a common core with selectable specialisms such as patient information, regulatory writing or research manuscripts. Possible content ranged from medical terminology, punctuation and sentence structure to statistical tests, hypothesis reporting, clinical trial design, research reporting, information organisation, ethics and guidelines. A 2010 conference discussion favoured clarity, consistency and knowing where to find information over questions about style conventions for which several answers could be acceptable.
In 2013, a critic questioned whether a broad multiple-choice, pass–fail examination could be meaningful, whether appropriate study references had been identified, and whether validation would distinguish medical writers from good writers and non-medical writers. The commission argued that a broad examination could provide meaningful indications of knowledge and experience and that essential proficiency was different from a lowest common denominator. It had not ruled out an essay or writing exercise, while portfolio review had proved subjective and burdensome for the organisations it consulted.
Examination scope and format
The 2012 design aimed to assess knowledge common across medical-writing settings, including ethics and data-reporting guidelines, literature searching, trial types, risk ratios, significance and language use for clarity and organisation. The examination was intended to avoid substantial overlap with BELS editing and publication standards or ISMPP publication planning and ethics, while accepting some overlap and focusing on writers across settings. In 2015, the commission likewise described MWC as complementary to credentials in publication planning, editing and regulatory affairs.
For the 2015 launch, questions were organised into five domains from AMWA's definition of a medical communicator: gathering, evaluating, organising, interpreting and presenting information appropriately for an audience, supported by communication expertise, ethical awareness and healthcare knowledge. Questions used contexts including public-facing materials, journal articles, continuing education, regulatory documents, grant proposals and pharmaceutical sales training and marketing. The examination then comprised 125 multiple-choice questions in 2.5 hours, administered on paper.
The 2019 outline described five abilities and their approximate examination shares.
| Domain | Ability assessed | Approximate share |
|---|---|---|
| Gathering | Finding needed information among available sources | 16% |
| Evaluating | Assessing information for validity and usefulness | 19% |
| Organising | Combining selected information into a cohesive message | 19% |
| Interpreting | Making the message meaningful for its audience | 19% |
| Presenting | Communicating clearly, concisely and accessibly | 27% |
Questions covered statistics, ethics, guidelines, regulatory writing, publications, continuing medical education, consumer writing and grants, rather than constituting an examination in a single specialism. A 2018 conference account described the DIA Medical Writing Competency Model as the examination's backbone, with ethics questions alongside the five domains and sample topics including epidemiology, writing mechanics, patient education, project management, statistics and regulatory submissions.
Eligibility and the candidate handbook
The programme was open to eligible medical writers worldwide, including non-members of AMWA. In 2012, eligibility was still being developed for publication in a handbook covering application requirements, policies, procedures and testing. By October 2013, the commission recommended two years of paid medical-writing experience or its full-time equivalent, documented in the application. Requirements presented in November 2013 added a bachelor's degree in any field from an accredited institution, a transcript, two supporting letters documenting relevant experience and a CV describing duties in each role.
For the first sitting in 2015, the two years of paid experience had to fall within the preceding five years; candidates also supplied a university transcript and two reference letters. An accepted application established eligibility to sit the examination, and passing conferred the credential. The handbook supplied examination content and format, sample questions, preparation references and information on the overall process. AMWA's executive committee and board reviewed it in October 2014, with a focus-group field test planned before publication.
In 2018, the handbook was updated to clarify qualifying paid work, and a separate qualifying-work-experience aid was available for applicants who were not employed as professional medical writers. Relevant experience described in a 2018 conference presentation included patient education and other public-facing materials, journal articles, continuing education, regulatory documents, research grants and pharmaceutical sales or marketing materials.
Preparation
The commission recommended using the content outline to identify strengths and gaps, then studying unfamiliar areas through the handbook's references, wider resource lists, workshops or other organisations' meetings. Work experience should provide much of the basic knowledge, and candidates did not need experience in every writing area or correct answers to every question to pass. The handbook's example questions were representative but were not taken from the examination, and annotated answers, FAQs and study tips were available by 2015.
The study guide was expanded in 2018 with the outline, topic and subtopic examples, revised preparation recommendations and resources grouped by competency; the handbook was updated for computer-based testing. The commission advised in 2019 that no single study approach suited everyone, while strongly recommending preparation. Reported approaches included reviewing workshop notes, targeted searches, Essential Skills workbooks, conventional study and study groups; the guide's sample examination could identify weak areas and its resource list could help select study tools.
Certificants' study approaches illustrate how preparation can follow individual gaps.
- An experienced non-regulatory writer reviewed the five domains and examples, used Tom Lang and Michelle Secic's How to Report Statistics in Medicine for statistics, and studied ICH guidelines and Common Technical Document components; she recommended the domains and guide as a development framework for newcomers building eligibility.
- One candidate organised a 12-week self-study syllabus around the outline and sample questions with explained answers.
- Another recommended the suggested references, regular study with a partner and writing practice multiple-choice questions, which she found harder than learning content alone.
- One candidate began six months ahead, marked topics by whether she knew them well, knew something or knew nothing, and obtained resources for gaps.
- Another advised allowing more study time than expected, tracing guessed or incorrect practice answers to their references, scanning other listed sources and using previous AMWA course examinations for review.
- A patient-education writer had to learn regulatory writing, publication management and continuing medical education, while a writer with more than 25 years in continuing education studied regulatory information most closely.
- Other tips were to attend workshops and review notes, refresh basic biostatistics and avoid assuming that a lack of regulatory experience ruled out passing.
Launch and access
The first sitting was held on 30 September 2015 in San Antonio before the annual conference, with applications due on 30 June. The credential's name, Medical Writer Certified (MWC), had been announced in late 2014. A second sitting was announced for the DIA meeting in spring 2016, subsequently described as March in Kissimmee with the exact date pending and applications due on 15 December 2015. The January 2016 announcement named 38 first certificants, including the commission’s co-chairs, and listed upcoming sittings on 15 April in Princeton and 6 October in Denver. A summer 2016 conference notice gave 31 July as the application deadline for that year's MWC conference sitting.
In 2018, the examination moved to computer-based IQT testing centres near major cities worldwide, with three-week windows in June and December. The commission expected more controlled environments and local and global access to broaden the applicant pool. The 2018 windows were 1–21 June and 1–21 December; application deadlines were 23 April and 23 October, and examination registration deadlines were 7 May and 7 November. The same June and December windows were announced for 2019, with applications approximately in April and October and registration approximately in May and November. Conference roundtables in 2018 also offered discussion of preparation strategies.
The commission reported 75 certificants by October 2018 and increasing applications. In summer 2019, it reported more than 70 holders, increasing examination participation, employers beginning to mention MWC in job postings and 218 US testing centres plus others worldwide. Although a 2018 commission update dated launch to September 2015, its 2019 account dated it to December 2015.
Recertification and the 2020 policy
Possible maintenance routes discussed in 2011 included retesting or documenting teaching, articles or continuing education. A five-year certification period was described in 2014, and a recertification handbook explaining procedures and qualifying activities was being finalised in 2015. By 2016, AMWA Online Learning identified activities eligible for continuing-education credit and maintained educational records for holders tracking their progress.
In 2020, the commission extended approved applicants' examination eligibility from one year to two, covering successful 2019 and 2020 applicants and later applicants; June and December sittings provided four opportunities. Certification lasted five years, with renewal through documented continuing education or retesting. Applications were due on 1 September of the fifth year, with rejected applicants allowed until 31 December to gain credits and resubmit; insufficient credits then required retesting. The commission advised anyone expecting to retest to use the June sitting of the fifth year to avoid a break in status. Because COVID-19 had cancelled educational opportunities, those first certified in 2015 received a one-year extension to submit renewal applications in 2021, or could retest.