PhD to Regulatory Writing

[Jim Ruble]

Hi everyone,

I'm a newly-minted PhD from a reputable US west coast university and my ultimate goal is to get into regulatory writing. I've taken and TA'ed some regulatory affairs courses during grad school, but as I'm sure many of you can attest to, it's hard to get a RW job without prior regulatory experience. So my plan is to get a job as a clinical research coordinator for a year or two, then try for RW again.

I know one of the first things you might be thinking is "you're overqualified!" I know - but I don't plan on doing it very long, I don't mind the local salary, and there's no way in heck that I'd go back to bench work as either a postdoc or a bench scientist. I just want to get clinical and regulatory experience. I also know that I might be able to get a CRA job, but I really don't want to travel much either. And as I said, I don't mind making a bit less for a year or two before I go back and try for RW again.

That being said, does this seem like a sound plan? Are there any unforeseen issues I'm not thinking of? Am I limiting myself in any way by taking a CRC job right out of grad school? Any feedback would be appreciated!

Jim

[D.X.]

Hi Jim,

Well first, I usually laugh when I read a newly minted PhD or Post-doc call themselves "over-qualified" for Jobs where they have no experience.

Especially for clinical research assoicates/coordinator roles. They may be easily accessible, I don't know, but don't under-estimate there responsiblity carried by CRAs when it Comes to ensure Quality and validity of a clinical study and linking to Patient safety. It is detailed work required a very detailed mindset.

A CRA role will not prepare you for regulatory writing. CRA role is very operational and admistrative when it Comes to the conduct of a clinical study - you're working under a Clinical Trial Opearations Group and you will be working alot with Case Report Forms (CRFs) for collecting patient Level Information. You'll be ensuring adherance to the trail protocol and looking at violations for example. I'm not sure you'll gain so much benefit to a Regulatory Role where the technical Details beyond CRFs are needed.

You can find entry-level regulatory writing roles on the Service Provider side - especially with those who provide Contract Research Services (CROs) and the same Folks who provide the CRA Services the Clinical Trial Operations Group in a Pharma Company. They will usually have Regulatory Affairs Services that they offer to their Pharma Clients as well. A good colleague of mine started in a CRO about 10 years ago as a Regulatory Affairs writer (grunt work), he's now Director-level Global Regulatory Affairs Lead for a Product Portolio.

I suggest you look at that path i suggest, rather than spending time in a CRA role. You will be doing grunt work at entry Level but well all Need to start someplace. I think a CRA role is good say if you wanted to go into Clinical Development or even Transition to other Scientific-functions.

And again let me repeat - avoid any perception you're "over-qualified". You're not. Othe wise - you run the risk of sounding arrogant and that will come up pretty quickly in an interview no matter what path you take.

Best,

DX

[Jim Ruble]

Hi DX,

Thank you for your reply - I appreciate your input. I didn't mean to imply that I'm overqualified by experience, merely that, at least from what I've seen in my research, most clinical research coordinators don't usually have a PhD. I have substantial experience in non-related areas, and I'm definitely willing to start at the bottom again and work my way back up.

I also appreciate your information about CRAs. I was wondering, though, about a clinical research coordinator position specifically. From what I understand, CRCs do a fair amount of regulatory documentation. Do you think this would provide good experience for regulatory writing down the road?

Finally, thanks for the suggestion about entry-level regulatory writing roles with service providers - I'll definitely look more into that. I have seen a few entry-level RW positions for local CROs, however in my area at least these seem to be few and far-between. I'll definitely keep my eye out, though.

Thanks again,

Jim

[D.X.]

Hi Jim,

Yes alot of CRAs and Study Coordinators dont have PhDs. Some can have a Nursing background and many with a just an undergraduate degree. Career advancement for them can be in Clinical Trial Operations where advance doctoral degrees are not necesary say contrast to clinical development where an advanced doctoral degree becomes necessary. Even perhaps Regulatory Affairs.

That being said yes as a coordinator you may have a role in collecting and maintain documents related to the conduct of a clinical study for regulatory reasons, i.e. Youradherance to ICH GCP to include data used for saftey reporting and data reporting ect. Yes you will get exposed depending on the role and how involved you are on that side. I think you can port that experience if that is a component, youll still deep dive databases and look at CRFs etc for monitoring and collection. You can still be hands on operationally like a CRA so read the job description well.

I still recommend you go right to regulatory writing that way it takes you closer to understanding the technicalities of say Regulatory Affairs and say have greater opportunity to see more cross-function inputs contracst what i would believe to be more siloed in a coordinator role. Up to you.

Good luck with what you decide, alot of those writer roles have high turn over, people dont stay in those roles long as they move to thier next step pretty fast after some grunt working so i think you could find something. Im assuming you want reg aff in a company? One other spot you could look is US FDA. They hire PhDs as Pharmacologists - youll review alot on the preclinical dossiers. You want regulaory? Why not just go to a "Health Authority" to start with. FDA i hear is a good place to get experience really fast. You work hard even during govt shutdowns (woo hoo PDUFA fees) but as i hear it...worth it.

Best

DX

[Caroline Ritchie]

Hi Jim,

I am a regulatory medical writer, and can attest that it is a very difficult role to get into at an entry level. Many pharmaceutical companies struggle to keep internal regulatory medical writers, and often outsource much of their work. Because of this, the internal writers often serve as project managers/vendor oversight and need to be very experienced in order to ensure quality from their vendors. I agree that a CRO may be a good place to start, as you are more likely to find groups with the bandwidth to help train/mentor you at a CRO than at a pharma company.

I actually started my career in scientific communications (SciComm). With experience writing manuscripts and abstracts, preparing posters, and putting together slide decks in graduate school, it is a much easier transition coming straight from a PhD program. I was lucky to work for a team in which the SciComm group actually sat on the clinical trial teams and wrote protocols and clinical study reports. Having that experience then allowed me to transition later into a purely regulatory writing role. This may be another option for you, as it would allow you to get your foot in the door in industry, continue to hone your writing skills, and become more familiar with the clinical trial process and challenges that arise during clinical development.