The credentials a medical writer can hold
Credentials available to medical writers cover distinct kinds of work, including life sciences editing, health education, continuing medical education, grant development, medical publications and regulatory affairs. Their eligibility requirements, assessment methods and continuing education requirements differ.
Life sciences editing
The Board of Editors in the Life Sciences (BELS) was founded in 1991 to evaluate manuscript editors' proficiency through an objective assessment. Ten editors active in scientific editing and publishing associations developed its certification programme with testing consultants, and the first examination was offered in 1991. BELS described its assessment in 2017 as testing life sciences editing against internationally recognised standards.
In 2007, BELS offered three credentials.
- Editor in the Life Sciences (ELS): earned by passing a three-hour multiple-choice test of scientific editing in English.
- Diplomate Editor in the Life Sciences (ELS(D)): earned by more experienced BELS-certified editors through formal review of a portfolio of edited manuscripts.
- Honored Editor in the Life Sciences (ELS(H)): bestowed on editors whose careers in life sciences editing had been outstandingly distinguished.
The diplomate programme was intended for certified editors with extensive experience in scientific communication in English; BELS described diplomate status as demonstrating exceptional editorial proficiency and greater mastery than ELS certification required.
In 2007, examination applicants needed at least two years' experience as a manuscript editor in the life sciences and a bachelor's degree or equivalent from an accredited institution. BELS defined manuscript editing as concern with both the form and intellectual content of a manuscript. Membership was not restricted to editors with life sciences degrees or life sciences editorial experience.
Almost 700 editors worldwide held BELS certification by 2007, and a 2008 account likewise described hundreds of certified editors worldwide. AMWA reported 37 of its members earning the credential in 2007, eight recent examination passes in a 2008 announcement and four in a 2010 announcement.
In the 2005 AMWA-Canada rate and salary survey, 33 of 135 members responded. Among respondents, 9.1% (three people) held BELS certification and 9.4% (three people) planned to obtain the new Certified Professional Editor designation offered by the Editors' Association of Canada.
Health education
The Certified Health Education Specialist (CHES) credential required passing a national examination. In 2007, eligibility required a bachelor's, master's or doctoral degree in health education from an accredited institution, or a degree plus a specified number of hours of acceptable coursework. Maintaining the credential required at least 75 continuing education units every five years.
Continuing medical education
The National Commission for Certification of CME Professionals (NC-CME) was established in 2006 and offered its first certification examination in June 2008. The Certified Continuing Medical Education Professional (CCMEP) examination covered competencies across CME, including adult learning principles, accrediting body regulations and requirements, and instructional design. Its stated purpose was to help organisations verify CME staff's knowledge and skills and demonstrate the integrity of educational initiatives to the public and government.
By 2010, 240 people had passed, certification lasted three years, and candidates had to complete an eligibility worksheet demonstrating their background in and commitment to CME.
Grant development
Grant Professional Certified (GPC) was a designation held by fewer than 200 people in the United States in 2008. One university research support writer received it in August 2008 after passing a seven-hour examination in May.
Medical publications
The International Society for Medical Publication Professionals (ISMPP) established the Certified Medical Publication Professional (CMPP) credential in 2009, and credentialed its first class at that year's annual meeting. It signifies knowledge and experience needed to plan, develop and implement medical publication programmes. ISMPP intended the credential to support a minimum acceptable standard of practice and assure the public and professional and lay media of the industry's commitment to scientific and professional integrity.
In 2009, examination eligibility required either a bachelor's degree or equivalent and at least two years of demonstrated experience in medical publications, or a high school diploma or equivalent and at least five years' experience. Candidates then had to pass a validated, three-hour, 150-item multiple-choice computer-based examination covering publication planning and development. The assessment covered a general core of skills shared across functions and disciplines rather than a single specialised role. In 2013, ISMPP continued to describe the 150-item examination as a validated qualification of medical publication expertise that demonstrated knowledge of best-practice standards and encouraged adherence to them.
Regulatory affairs
In 2011, the Regulatory Affairs Certification (RAC) programme was administered by the Regulatory Affairs Certification Board, which was responsible for its content, policies, standards and administration. Four certifications covered the following areas.
- RAC (US): United States regulations.
- RAC (EU): European Union regulations.
- RAC (CAN): Canadian regulations.
- RAC (General Scope): the general scope of practice of regulatory professionals.
The examinations were intended for people already working in regulatory affairs and covered a wide range of regulatory topics and health care products. Eligibility in 2011 required a bachelor's degree or equivalent, or at least three years of regulatory experience. Each examination comprised 100 multiple-choice questions testing recall, application and analysis. A 2014 account described four competency areas: strategic planning, pre-approval, approval and post-approval.
RAC recertification in 2011 required 36 continuing education credits every three years. Eligible activities included conference attendance, speaking or writing on regulatory topics, and service as an officer, director or committee member of a relevant professional society, across regulatory affairs, the biomedical sector, the health care product life cycle and related professional development. The recertification fee was $100 for members of the Regulatory Affairs Professionals Society and $285 for nonmembers.
The Regulatory Affairs Professionals Society (RAPS) offered both a certificate based on completing courses and certification based on eligibility and an examination. In 2014, its course-based certificate covered pharmaceuticals, medical devices or both and could be completed online.