Best Route to a Regulatory Medical Writing Career

[Frances Vakarcs]

Hello Everyone,

I have been out-of-work since August 2008 and I cannot find a job even with over 20 years in clinical research. I need to transition into other work because of a disability caused by excessive overnight travel (hearing loss) and I have been investigating transitioning into the Regulatory Medical Writing field for over 1 year. Even after contacting the AMWA I cannot seem to find any information about the best way to get training and experience so that I could get entry-level positions. There is a government agency here in the State of Washington that may help me but I need to submit to them cost estimates for education and evidence that I would be likely to get a job. Everything appears to be very expensive and after talking with the AMWA people about their certificate program I am somewhat confused. I need to get going and I would sincerely like to become a medical writer and specialize in regulatory. I have a Master's degree in Clinical Research Administration so I know the regulatory processes and I understand the data.

So my question - is there a educational program that is respected by biotechnology or pharmaceutical company hiring managers and would help me get an entry-level position?

Is there anyone out there that can help me with a roadmap for education and training for someone eager to get into regulatory medical writing but cannot afford high tuition costs? I need to get information on paper so that I can submit it to the agency that is helping me. I would appreciate any help because I feel lost and I could not pry information from AMWA. Frances

[Frances Vakarcs]

Hello Sohini,

Thank you for your response and the information. The program at USP sounds excellent but a person on this forum indicated the tuition prices start at $4,000 per class (Yikes). Nevertheless, I am going to call them about their certificate program in Regulatory Medical Writing next week. Also, there is the factor of time. It is a difficult situation but you are correct that spending time on quick study courses that only give a certificate of completion (AMWA) may ultimately prove to be the least efficient if hiring managers don't give them merit.

It would be a shame for my knowledge and experience in the clinical research industry to go to a complete waste. I could put my education and experience to use as a Regulatory Medical Writer but it appears very tough to break into the field. Recruiters will not help. I was talking with a recruiter recently about what appeared to be a mid-level writing contract opportunity for writing INDs and NDAs. The person that got the position had a 4-year degree in history but had 3 years of writing experience. That seemed odd to me because I know all about the IND and NDA process and how to interpret the clinical data, yet, a person with no experience in the industry but just a few years of writing got the job. I would think that understanding the IND and NDA process and being able to understand the data would be important? From what I know there are formats for writing the documents that are part of an IND submittal package (like CSRs) but I would need to learn the formats and get the experience. It is very frustrating for me but I am trying to turn my outlook around and think about my situation as a new road to be taken. I have applied for writing positions through Aerotek and I get no response from them. In fact I get no response from Aerotek at all even on positions for which I am way over qualified. But I will contact the Atlanta Aerotek folks.

By the way, I also have a 4-year degree in Environmental Sciences/ Urban Land Planning. I only worked in the field for 2 years because of employment opportunities in the early 1990's. Are there writing opportunities in the environmental arena? Frances

[Frances Vakarcs]

Thank you Sohini,

I will look for the contact information for Dr. Dodgson or Dr. Mac. Their program sounds promising.
Take care, Frances

[Wanda Reese]

Frances,
I'm very late to this discussion, and hope you've found a viable route to what you need. I can totally relate to your dilemma---regulatory is tough to get entry-level work into, and those who have, have largely "fallen" into that line of work, I've learned. I've been fortunate enough to have landed some regulatory work as a freelancer.
I echo Sohini's advice. As a current USP grad student, and knowing their placement rates, if you already have a Master's getting another one for this line of work would be a waste of your money and time---and USP's program is UBER expensive. I'm already almost $70k in debt, and the prospects of their career placement services finding me work are not that promising. Not knocking the institution or the program, at all. But you're in a different dimension where that program is concerned and it wouldn't be a wise use of your dollars or time. A regulatory writer told me that employers don't care as much about education or contacts, as they do experience. So your focus would need to be getting the experience. Dr. Dodgson, as Sohini told you, was the architect of the USP program, and now she works solely as Editor-in-Chief on MJoTA. The real benefit of the program, which teaches both regulatory and marketing writing in pharma, is that it's quick, affordable, one-on-one, hands-on AND they help you not only get published, which is a real star on your forehead with employers---and help you get work. You should contact her right away. Email her at [e-mail].
~Wanda