Why You Shouldn’t Get a Certificate Before Breaking Into Regulatory Writing

Here’s what hiring managers actually care about...and what they ignore.

Hi Future Regulatory Writers,

The biggest waste of money I see aspiring regulatory writers make?

Getting a certificate before they even start in the industry.

If you're burned out, curious about regulatory writing, and wondering what to do next, this thought has probably crossed your mind:

“What certification do I need to break into this field?”

It makes sense.

Especially if you’ve been conditioned to believe that another degree is the only way to move forward.

But here’s the truth:
Skills matter more than credentials.

I’ve built a successful career over the last 9+ years in this industry. I’ve worked with more than 15 pharma clients. I’ve earned more than I ever did in healthcare.

And I’ve never once gotten a certification.

You don’t need more schooling.
You need a smarter strategy.

Let me show you how.

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Myth vs. Reality: Do I Need a Certification?

Every industry has its myths.

For regulatory medical writing, this is the most common one:

🚫 Myth: You need a medical writing certificate or an advanced degree.
✅ Reality: Hiring managers rarely care about certifications. They care about results.

How do I know?

Because I’ve sat on the other side of the table, reviewing candidates. The best candidates weren’t always the most credentialed.

They were the ones who could:

• Pay attention to details

• Write clearly and concisely

• Collaborate well with cross-functional teams

• Navigate Microsoft Word formatting like a pro

• Understand clinical trial flow and regulatory basics

You don’t need to reinvent yourself.

You just need to reframe what you already know.

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When (If Ever) a Certification Might Help

I want to be fair…

Certifications do have a place.

I didn’t get one because I was drowning in student loan debt. I didn’t have the luxury to wait. I had to move quickly and creatively.

That said, certifications can be helpful in certain cases:

• You’re competing with highly qualified candidates

• You want to specialize in submissions or niche areas

• You’re coming from a non-clinical background and need extra credibility

If you are the type of person who would feel more comfortable understanding the industry fully before jumping in, I would highly advocate that you take a look at this page here for more information.

Still, even the best certifications—like those from AMWA—don’t guarantee anything.

Hiring managers still want proof you can write, organize information, and understand clinical trials.

Education is never a shortcut.
It’s an optional supplement, not a starting requirement.

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What to Do Instead: The No-Certification Path

When I started out, I had nothing.

No plan.
No connections.
No formal training in drug development.

The only thing I had going for me?

I refused to quit.

Here’s the path I took to break into regulatory writing…

No certificate required:

Step #1: Learn the Basics (Without Paying Thousands for a Course)

• Understand drug development (Interested? Check out this article here)

• Read through public FDA guidance documents (ICH E3, E6, and M4)

• Read this book (I read it at least twice a year)

Step #2: Network, Network, Network

Every job I’ve ever had came from LinkedIn. Every one.

Networking is the secret sauce of this industry.

It’s not optional—it’s how the work gets done.

Step #3: Gain Experience Without a Certificate

Everyone hates this catch-22:

“You need experience to get the job…but need a job to get experience.”

Here’s how I solved it:

• Took freelance editing or quality control gigs

• Subcontracted on someone else’s writing projects

• Said yes to smaller tasks until bigger ones came my way

I didn’t feel ready.
You probably won’t either.
But your clinical background is more valuable than you think.

You just need to translate it.

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The Secret? Reframing Your Experience

Here’s the real superpower behind any successful career pivot:

Reframing.

Take what you already know and show how it applies to regulatory writing.

You don’t need to change your background.
You need to change how you present it.

This starts with your resume.

My biggest mistake early on?
Trying to sound impressive instead of sounding relevant.

That’s why I created the Regulatory Writing Resume Blueprint.

It includes my exact fill-in-the-blank resume template and the positioning strategy that helped me stand out.

Focus on:

• Transferable skills (documentation, attention to detail, communication)

• Familiarity with key guidelines (even if self-taught)

• Any writing/editing experience (from any context)

When you stop chasing degrees and start highlighting skills, hiring managers take notice.

Need help refining your resume?

Check out my Regulatory Writing Resume Blueprint now!

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The Fastest Way to Get Started (No Certification Required!)

Getting your first job is the biggest hurdle to becoming a regulatory writer.

But I cracked the code.

I am proof:

• You don’t need a certificate.

• You don’t need another degree.

• You need a plan—and I’m about to give you one.

I am routinely asked how to get your first regulatory medical writing job without experience and I decided to take a video and outline, step-by-step, how I started to gain experience.

Check out the video below to see exactly how I found my first subcontractor opportunities that put me on the track to the career that changed my life.