Using a special interest group to enter a niche
A special interest group gives a member moving into its specialism a way in: a glossary of the field's terms, links to guidance and templates, a listing of the association's training in the field, and a chance to put questions directly to regulators. Beside the group, the association's journal and its archive, its workshops and its symposia also support the move.
What a special interest group supplies
EMWA's pharmacovigilance special interest group aims to act as a resource for any medical writer interested in pharmacovigilance, whether already working in it or new to it, and posts updates to guidance, new templates and any information it receives from the regulatory authorities in its area of the EMWA website, where anybody can access them.
At its start the group found a knowledge gap: people did not really know what pharmacovigilance was, and there was not a lot of experience to begin with. One of the first things it produced was a glossary, meant to demystify the many acronyms and abbreviations of pharmacovigilance, and it is used quite a lot. The group's area of the website also lists external links to regulatory authorities, templates and guidance for pharmacovigilance writers, experienced or not, and all the pharmacovigilance articles published in Medical Writing, which members can open directly in the journal's archive.
The group is very often asked which EMWA workshops someone should take who wants to get into pharmacovigilance, or who has worked in it for a while without formal training. In answer it posts a listing of all the pharmacovigilance-related workshops EMWA offers, showing which are more fundamental and which more advanced, without endorsing any particular one. The listing is also meant to encourage more workshops on pharmacovigilance topics at EMWA. In the opinion of the group's first chair, all EMWA's workshops are excellent; from her role on EMWA's professional development committee she knows that they are very thoroughly evaluated, and she would recommend any of them.
In early 2018 EMWA's medical device special interest group welcomed every interested member: anybody could join it to discuss and brainstorm, and members could send their questions to the email addresses on the EMWA website, which the group would try its best to answer. One of its members described the group as new, with everyone in it learning as they went along. For a writer moving from pharmaceuticals into devices, the medical device special interest group was also a resource where EMWA members could tap into the regulations and guidelines.
Questions put directly to regulators
In every interaction with the regulatory authorities, the pharmacovigilance special interest group asks them to be open to a question-and-answer session, so that any medical writer can ask their experts any question about the pharmacovigilance topics under discussion. The group's first chair counts this among the most valuable things the group offers: a medical writer can put specific questions about documents, the way they are written, guidance and templates directly to a regulatory authority, an opportunity that does not arise often outside EMWA and that the group worked very hard to achieve for EMWA members, and she encourages every medical writer to take real advantage of it.
The association's journal, workshops and symposia
Around the middle of 2017, as one writer was moving from pharmaceuticals into medical devices, Medical Writing ran an issue themed on devices, with many articles about writing for them. She found it very comprehensive: it covered what a medical device is and the issues around devices, and it carried an article on writing for pharmaceuticals and for medical devices that, as she recalls, discussed quality of life and stress and reported a survey on them. Having wondered from pharma whether device work would be very technical, she was reassured by the issue that the move was possibly something she could do.
Around the same time EMWA advertised a symposium on medical devices for May 2018, promoting it in the journal. She used the journal to reassure herself that a writer can move from pharmaceuticals to devices, to help secure her position at a new med-tech company, and to make her case to that company against what she calls a kind of naivety, the expectation that a writer will arrive with device experience. She attended the symposium and workshops on literature review, on the clinical evaluation report, on the clinical investigation plan and on moving from pharma to medical devices. In her view, in late 2019 EMWA had a wonderful portfolio of workshops for a writer who wants to concentrate on medical devices, more symposia were coming, and a writer can use them to support the move.
Beyond the themed issue, the journal had consistently carried articles on devices, if less extensively, going back two or three years, and many earlier webinars had covered them. The journal is completely searchable, and even a new member can download a previous edition.
A writer who had herself moved between fields holds that an EMWA member who decides to try to get into medical devices is not alone, since the association offers a lot of support: many training opportunities, materials online to read, colleagues to ask and the special interest groups.