You Think You Need a Medical Writer?

Please allow me to introduce one of the newest members of our McCormick LifeScience crew who has simply added levels of experience (and humor!) to our great team!  Lauren Agnotti, is a medical writer with over 10 years of experience, spanning trade journal articles and NDA submissions. She does not LARP (live action role play), and last wrote poetry in middle school. 😉 

Take it away Lauren!

You think you need a medical writer, but maybe some others on your team think that the company “isn’t ready” for one. Or maybe everyone on the team thinks you need a medical writer two weeks ago and why hasn’t one appeared yet to solve all they problems? What’s going on here is less a disagreement on staffing needs (or “readiness”) and more of a mosaic of past medical writer experiences.

Yes, we’re a diverse lot, with a variety of skill sets, and not every writer is a fit for every bundle of needs. Overall, there are two main types of writers:

• Scientific communications writers: These are writers whose specialty is publications, posters, abstracts, IMCJE and journal submission requirements, CME materials, MedComm content (slide decks, MSL information, FAQs), potentially Medical Information writing (eg, standard letters). They likely have publication planning and strategy experience. They are typically part of Medical Affairs.
• Regulatory writers: These are writers whose specialty are documents intended for regulatory agencies: the components of an eCTD (that IND and NDA behemoth), including IBs, clinical protocols, summary documents, safety reports, agency response documents, and briefing books. They are typically part of Clinical, Medical, or Regulatory.

Most medical writers prefer and have experience in either scientific writing or regulatory writing; however, that does not mean that the skill sets are not transferable.

The educational backgrounds of medical writers are diverse (many, but not all, have advanced degrees, and unless your structure requires, for example, clinical scientist to also be a medical writer, the degree is generally of little consequence).

Most medical writers excel at translating sciencey techno-speak into language tailored to the audience of a given document. Some writers have extensive editing experience (eg, certification from the Board of Editors in Life Sciences (BELS)). Some are excellent QC reviewers (and love it) others are not as great at it (and maybe despise it). Some are very technically savvy (and can fix persnickety Word documents lickety-split), others are pretty good at typing.

Some love cross-functional interactions and managing groups, others would rather be left alone to their QC document. Some are sciencey and LARP in their free time, others were liberal arts majors write poetry in their free time. Most have clinical experience, many run away at the sound of the word “nonclinical.” Some love writing SOPS, others find patient narratives fun, others are all about protocols and/or CSRs. Which experiences are most important for your team?

Medical writers often have a lot of experience in at least a couple of disease areas and document types. Experience is actually one of the major hurdles of getting into medical writing: you need experience to get hired, but you can’t get experience if no one will hire you. Since most non-entry level positions (medical writer or otherwise) are hired based on experience, team members often have strong ideas on how things should be done. When you have a medical writer, a medical director, a clinical program manager, and a regulatory director (all of whom have strong and valid opinions and experiences) all in the same room debating a protocol amendment, the result is not always kumbaya. All that’s needed there is respect and collaboration.

So, does your team need a medical writer? Is it ready for one? If the questions are being asked, then the answer is “probably.” The trick is defining the (two to three) things for which your team most needs a medical writer, and then finding a writer with a complementary skill set and who will also collaborate well with the team.

• If you’re thinking you need a medical writer (and maybe not everyone is convinced the team is “ready” for one), you probably do indeed have areas in which the right medical writer can be a value-add.
• Medical writers tend to prefer and focus on either publication-type, Medical Affairs materials, or on regulatory agency documents.
• Try not to get too hung up on the specific degree background of a writer – medical writers are more defined by their document, disease area, and industry experience than by their academic degrees.
• Define what you most need out of a medical writer, and ask candidates what they most like to do. Then your cross-functional meetings will be set up for collaborative success.