QUESTION
of the Week!
"I have been a science writer (focusing on the life sciences) for about 20 years, working in consumer magazines, university and nonprofit communications, and museums. I have been freelancing for about five years, and recently my work has turned from basic biomedical science toward clinical topics--newsletter articles, patient information, and materials for websites. I would like to broaden my expertise (and client base) by learning regulatory writing. In addition to attending courses at the AMWA annual meeting, how can I get started? Is it helpful and/or necessary to work at a full-time job in this area before freelancing? What technical expertise do I need to build up? Is it necessary to have an MPH or other degree? What organizations, institutions, or companies employ regulatory writers on a contract basis?" --Elizabeth Hanson
Hi, Elizabeth,
Thanks for contacting us with your questions about regulatory writing. First of all, full disclosure, neither of us works in regulatory writing. It's just not something we enjoy, but we have an enormous amount of respect for the folks who do it on a regular basis. In fact, a few months ago we approached two colleagues who are regulatory writers about writing a book for our series. They agreed, but it will be a while before the book gets into print.
Regulatory writers must be adept at working with data management and clinical operations groups to review and interpret clinical trial data. They must compile, write, and edit regulatory materials (Investigational New Drug [IND]/New Drug Application [NDA]), with specific emphasis on clinical study reports, investigator brochures, and serious adverse event (SAE) narratives.
Regulatory writers need a keen knowledge of FDA regulatory requirements, Good Publication Practice (GPP) and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines, including strong familiarity with the eCTD (electronic common technical document, used now by most companies to submit documents). No specific degree, such as an MPH, is required, but most companies look for people with at least a Bachelor's degree in a science-related field plus 3 to 5 years of experience.
Regulatory writing is very rigid and follows strict formats. In our opinion, the best way to get into regulatory writing is to work initially as a staff writer rather than freelance. That way you can learn the company's approach and format and get tips and guidance from fellow writers in nearby cubicles.
Mid- and large-size pharmaceutical companies hire regulatory writers as employees to work on site. Smaller pharmaceutical and biotech companies often go through staffing agencies and recruiters to hire regulatory writers on a contract basis. Susan Caldwell, a regulatory writer, sends out the weekly Biotech Ink Insider newsletter with a listing of regulatory writing jobs that are available. Subscription is free, and you can see what kinds of companies are hiring regulatory writers and the qualifications they seek. If you have not already joined our mailing list to receive our free monthly newsletter Pencil Points, as well as other announcements, click here to join our list.
In terms of learning regulatory writing, the Regulatory Affairs Professionals Society often hosts introductory meetings that provide a look into the "day in the life of" a regulatory writer. The University of the Sciences in Philadelphia offers a degree program in regulatory writing.
Several of our colleagues have gone through this program and give it high marks. Our local AMWA chapter, the Delaware Valley Chapter (AMWA-DVC), will be hosting a one-day workshop on regulatory writing on September 29, 2010. Check the website for details about the program. If you're close by, you may want to attend.
We wish you success in pursuing regulatory writing and if we can be of any help in the future please get back in touch.
Everyone who’s ever been successful has had a mentor, and we’re no exception. In fact, over our careers we’ve had (and still have) many mentors—counseling us in different areas and providing differences of opinion so we can make informed, and hopefully better, decisions.
Over the years, we’ve counseled many current and want-to-be freelance medical writers. We speak to them at conferences and workshops where we present, and sometimes even communicate with them directly via phone and email. But unfortunately, we can’t reach many people that way. At least not as many people as we would like, because so many people have questions about how to become, or become better, freelance medical writers.
That’s why we created The Accidental Medical Writer series of books and this website, so we can reach more people who are in search of information and answers. Please don’t think that we know everything, or even most things, because we certainly don’t. And don’t take our thoughts and opinions as gospel, because thoughts and opinions are like relatives—everyone has them, and some of them can be pretty flakey.
The advice we give is our own, and it is based on our own personal and professional experiences. It does not reflect the opinions of any organizations to which we belong, and it is not going to be right for everyone.
Provided you don’t have uncontrolled hypertension, take everything we say with a grain or two of salt. Our opinions and advice are based on nearly 40 years of combined experience as freelance medical writers, but they are opinions and advice nonetheless.