By ScienceDocs Regulatory Writer Dr. Chen
When you are hiring a regulatory writer for a project, it is helpful to flesh out the role you would like the writer to play. The role of regulatory writers can range from someone who is actively involved with the document development process from the beginning to someone who participates in the end stages of the process. Over the past 20 years, the realm of responsibilities in regulatory writing has increased substantially and now may include providing input on template design, shaping arguments, acting as project manager, searching for literature, reviewing data, composing the first draft, and ensuring document compliance to regulations. Defining the essential duties of the position will allow you to find the candidate that is the best fit.
Experience matters in regulatory writing, and here are some reasons why:
- Some regulatory guidelines require a minimum level of background and training for the medical writer. The European Commission guidelines for clinical evaluation for medical devices states that evaluators, including medical writers, should have “…at least the following training and experience in the relevant field: a degree from higher education in the respective field and 5 years of documented professional experience; or 10 years of documented professional experience if a degree is not a prerequisite for a given task.” If a writer has less or different experience, device manufacturers need to be prepared to justify it to the regulatory authorities.1
- Sound interpretations of regulatory guidelines may provide key support to the project team.2
- Updated knowledge about regulations in the pertinent area of expertise is important, since regulations are constantly changing. For example, the FDA has a web page dedicated to newly released regulatory guidance documents for drugs.3
- Understanding the relevant product (drug, medical device, diagnostic, or chemical) development processes improve efficiency as well as quality of team interactions and submission documents.
- Skill in leading teams or acting as a project manager can help increase efficiency and effectiveness of the project team reviewing the regulatory documents. This skill may ultimately produce better documents. 4
- Experience in relevant novel technologies/areas that have no or limited approved products can aid in developing regulatory strategy and rhetorical arguments.
- A longer tenure in a pertinent field may correlate with a larger network of experts that may help address issues that the writer herself cannot address.
In summary, define which responsibilities are critical to your regulatory writing position after considering the above points. This will allow you to home in on the most suitable person for the position. Many regulatory writers have a broad range of training apart from writing, so they may have skills that you as a client didn’t anticipate. Therefore, if you need a writer to perform a specialized role in addition to writing, ask ScienceDocs if they have personnel to meet your needs.
- European Commission. Guidelines on Medical Devices – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC. MEDDEV 2.7/1 revision 4. http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/en/renditions/native. Revised June 2016. Accessed October 3, 2016.
- Tomlin, RC. Online FDA Regulations: Implications for Medical Writers, Technical Communication Quarterly. 2008;17(3):289-310.
- US FDA. Newly Added Guidance Documents. https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm121568.htm. Updated April 24, 2017. Accessed May 25, 2017.
- Ford, JD, Bernhardt, SA, Cuppan, G. From medical writer to communications specialist: Expanding roles and contributions in pharmaceutical organizations. American Medical Writers Association Journal. 2004;19(2):4–11.
Learn more about Regulatory Writer Dr. Chen