Regulatory Writing

[Ingrid]

Hello, as a newbie I posted the following inquiry on the Newbie Forum. I was told I should post it here:
Hello to All:
This is my first time to the forum. I am an experienced medical editor and writer with a few higher up positions in the field. I was also briefly a writer at Eli LIlly and Company. (There's a lot more to my writing than just medical, but no need to mention it here.)

My question today is this. Although I have been in this field 15 years, I have yet to figure out how to break into medical and pharmaceutical regulatory writing. I kinda know what it means having worked at Lilly and all. There are INDs, FDA documentation, CSRs, etc. However, aside from a couple of courses offered once in a while from the University of Chicago, how do I learn more about this type of writing?

Once I do learn the technique and required media, how do I pick up freelance assignments in regulatory writing? I have been dancing around this field forever, and would appreciate any help!

Have a great day! Ingrid

[Tish Davidson]

Do you belong to American Medical Writers Association? http://www.amwa.org
They have writing certification courses (I've never taken one) and a professional job board accessible only to members that often has ads for regulatory writers. There are also head hunters who handle contract regulatory writers and companies that specialize in providing contract writers for drug development filings with the FDA. I've looked at the U of Chicago course, but it is expensive.

[Ingrid]

Thank you for your reply. Although I appreciate your suggestion, this is what I found: Yes, I am a member of AMWA, as well as a member of NASW and SPJ. It seems like the courses through AMWA, at least in their description, pertain to those already in a regulatory writing role. Moreover, the freelance work they advertise in that area are predominantly those with advanced degrees in pharmacy, nursing, or even medicine. Yet, I know there are people out there doing this type of writing without these qualifications. (I'm stuck doing other types of medical writing as a result.) Any other suggestions, please? Thanks again!

[Bamponang]

Ingrid, excuse me for being dense, but when you say regulatory writing, do you mean:

- Doing compliance documentation for an organisation etc
- Doing news stories on regulations that have just been promulgated, bills under consideration, trend and analysis pieces - published by medical/trade publications?

I do the latter type of writing, but different media ( telecoms)and country. So I can't elp you with specifics.

One opportunity I can see is for you to query your current editors for legal type stories, so you can build related clips. Maybe an analysis piece of a regulation that has just been promulgated?

Doing news/analysis/features will also help you connect with people involved with the industry on the inside - those who write the regulations, do the documentation to help their companies comply, analysts who can discuss at length provisions that are problematic etc, law firms that specialise with that type of legal/regulator work etc.

These are the people who will not only serve as your source for news/analysis stories, but can potentially hire you/tell you if there are job opportunities for the documentation type regulatory writing in their organisations.

I hope this helps.

[Ingrid]

Hi again! The definition of regulatory according to the pharmaceutical and medical industries is a bit different than your understanding of the term, as far as I can tell. The FDA requires certain documentation for drugs and devices from Phase I study through Phase IV, and even including some post-marketing materials. These include IND proposals and CSRs among other documents. Kind regards, Ingrid

[Tish Davidson]

What kind of writing have you done so far? I ask because I'm wondering how to translate it into something that companies who want regulatory writers need. I'm a medical writer, but I don't do regulatory work for several reasons, one of which being that most of the work I see is contract work that requires the writer to be on site. I an not interested in on-site work so I do mainly textbooks, encyclopedia articles, patient information, disability information, and ghosting. However regulatory writing definitley pays better.

[Ingrid]

Hi Tish:

Thanks for taking the time to consider my request. I have written/ghostwritten peer-reviewed journal articles, medical trade newsmagazine pieces, consumer trade magazine articles, slide presentations, textbook chapters, patient education materials, press releases, abstracts, speeches/scripts, conference roundtables, and Web-based articles. I probably have written other stuff, but can't recall. I am also a newspaper columnist and reporter. You hit the nail on the head when you said that you noticed these writers are typically in-house contract writers. I've been told the pay is better, but to be careful what I wish for. This advice came with the caveat: it may be too dry of a style of writing to satisfy my creative muse.

Kind regards, Ingrid

[Tish Davidson]

It looks like what you have done is just about the same kind of medical writing that I have done (I also was a reporter and columnist before I got tired of tracking people down and having them not return my phone calls). I can't really offer you any help or advice about freelance regulatory writing. When my last child went to college, I had intended to apply for some on-site contract jobs (I live in an area where there are some biotech companies.) and see if I liked working away from home. I thought if I got some on-site work in medical devices or pharmaceuticals, I could then work my way into regulatory writing, which is what I would like to do if I were to stop freelancing. But when my husband and I talked it over, we decided that our quality of life was better when I worked at home and about that time my elderly parents started needing more care, so I gave up the idea of an on-site job.

Anyway, I like best simplifying medical jargon so that it will be understandable to ordinary people. It makes me feel useful. I am not sure regulatory writing would give me the same satisfaction. Good luck. Let us know how things turn out for you.

[cray]

Picking up freelance regulatory writing without previous experience is going to be extremely tough.

The best way to get into it would be to take a contract position in a Regulatory department and grow from there. You have previous pharmaceutical experience as well as writing experience -- you'll be able to market yourself best from the inside.

...oh, and you'll have to familiarize yourself w/ the regulatory guidelines. yipes.

Feel free to contact me if you'd like to discuss further -
cray001@verizon.net

[Ingrid]

Hi Cray: I sent you a message at your personal e-mail address. Did you get it by chance?

[cray]

Hello Ingrid,

I just got it this morning. I was on vacation for a few days.
I'll respond by email today!

Cray