Hi Future Regulatory Writer,
I have been in clinical research for over 10 years.
My big break, the first solo contract that changed everything, came in January 2021. If you have followed this newsletter for a while, you know the shape of that story. Cold outreach, a lot of rejection, and 1 yes that changed my life.
Here’s the part I don’t say as often.
If I were starting today, I would not do it the same way. The path I took still works, but the field around it has moved, and some of what took me months would now take you an afternoon.
Below are 3 things I would do differently if I were trying to break in right now, drawn from 10 years in the work and a seat on the AMWA Education Committee.
I have told the full version of that first break before: the paycheck that did not feel real and the studio apartment where it happened, so I will not retell it here.
#1: I would build skill before I reached out
When I started, there was no way to practice the actual work before someone hired me.
I learned on the job, under deadline, hoping I could make sense of a clinical study report faster than anyone noticed I was still figuring it out. The people who said yes were taking a real risk, because I had nothing to show them except willingness.
That is the part you can change now.
The tasks a consultant first hands a new subcontractor are learnable in advance:
Formatting a document to a template
Running quality control on a section against its guideline
Updating a document according to the client’s style guidelines
You can practice each of those on real material before a single conversation, then speak to them plainly when you reach out.
Proof changes how outreach feels. You stop asking someone to bet on your potential and start showing them what you can already do.
#2. Targeted > Broad
My method of outreach was volume.
I sent more than 50 messages a day, most of them close variations of the same note, and I did that for 2 months before it started to work.
It worked, but it was brute force, and brute force is expensive.
If I were doing it now, I would send a fraction of the messages, each one aimed at the right consultant and researched before I hit send, and spend the saved hours making sure every note showed I understood their work and how I could lighten 1 specific load.
Volume isn’t a strategy.
The directory that made this possible has not changed, and I still recommend it as the way in.
#3: I would make myself easy for recruiters to find
I ran my whole search on outbound effort.
Once I was qualified and had a solid amount of subcontracting experience under my belt, that was when things stalled a little longer than I’d like.
Two moves would fix that today.
First, I would find the recruiting firms that source these roles in volume — the ones that hold direct relationships with the companies doing the hiring — and connect with “Regulatory Medical Writing Recruiters” at their organizations.
Getting on the radar of the people who fill these positions beats broadcasting into the void. The best part? Once you have a few solid relationships, they can help you get additional work over and over.
Second, once my profile genuinely reflected the work, I would turn on the “Open to Work” setting appropriately, using the option that shows it to recruiters only rather than to my whole network.
Done in that order — updated profile first and signal second — you stop chasing and start getting found.
I have previously written about the specific profile changes recruiters notice, and this only works once those are in place.
None of this is theory for me.
The volume approach still got me there, which is the only reason I can tell you with confidence that it works, but also that it is the slow way. The field has grown more open to people entering it deliberately, and the tools that shorten the path now are the ones I wish had existed when I was sending my 50th message of the day.
Help me help you.
Would it be helpful if I created a comprehensive guide that helped you set up your LinkedIn so recruiters would come to you?
Reply and tell me. I read every reply.
This Week in The Regulatory Writing Lab
The first thing I said I would do differently is build proof before reaching out. This is where you build it, on the exact kind of passage that separates a finished objective from one that only looks finished.
EX-004: An Objective Without a Comparison
You are drafting the primary objective for a Phase 3b placebo-controlled trial of a biologic for moderate-to-severe plaque psoriasis. The objective names its instrument and its assessment time points and reads as though it is finished. Your job is to find the weakness a reviewer would catch and rewrite it. It is among the quietest ways an objective fails review, and most writers read straight past it until a reviewer points at it.
