The 4-Part Resume Framework

How I got recruiter responses in 2 months

Hi Future Regulatory Writer,

Your clinical resume got you your clinical job. But that same resume is costing you regulatory writing interviews.

And here’s what makes this worse:

The regulatory writing industry is small. When you reach out to recruiters before your resume is ready, they remember.

I learned this the hard way.

Later in my career, I realized (even from the beginning) I had the right experience that recruiters were looking for; I just didn’t know how to reframe it.

My original resume was minimal and task-focused.

The most “applicable” things I had were my undergraduate research and CNA work. I was listing generic tasks from my CRO role (without knowing which ones were important). It was the kind of resume that might get you a CNA position, but it would never land a contract paying $100+ per hour.

Then I got lucky.

After scouring LinkedIn and sending tons of messages. Eventually, my future mentor responded.

She had been in the industry longer than I’d been alive. She taught me what recruiters actually look for in a regulatory writer’s resume:

• the terminology

• the formatting

And how critical it is not to make grammatical or spelling errors when you’re applying for a high-end writing job.

After a few iterations and her guidance, she approved my final resume.

Within 2 months of implementing her changes (and optimizing my LinkedIn to attract recruiters), I started receiving positive feedback and more interviews.

After discussing the components and strategies with my mentor over the years, I developed a 4-part framework.

Let’s dive in.

---

The 4-Part Resume Framework

Every element works together:

1. Strong Professional Summary

2. Reframed Professional Experience

3. Strategic keyword placement

4. Structured Education section

Let’s get started.

Part #1: Professional Summary

Your summary bridges your clinical background to regulatory writing value in 3 to 4 lines.

The principle:

Position yourself as a clinician transitioning to regulatory writing, not as someone leaving healthcare. You’re applying your clinical expertise in a different format.

Examples:

Before: “Experienced registered nurse with 8 years in acute care.”

After: “Clinical professional with 8 years of acute care experience transitioning to regulatory medical writing. Expertise in clinical documentation, adverse event recognition, and synthesizing complex medical data into clear, compliant records.”

The difference?

The “after” version uses regulatory keywords (documentation, adverse events, compliant) while maintaining clinical credibility.

It tells recruiters exactly what you bring to the role.

Part #2: Professional Experience

This is where most clinical resumes fail.

You’re listing what you did, not what skills you demonstrated.

You’re not missing the skills. You’re already wired for regulatory writing.

Your resume just needs to demonstrate it correctly.

The principle:

Show analysis, synthesis, and documentation skills. Use regulatory terminology naturally.

Examples:

Before: “Provided patient care to 15+ patients per shift.”

After: “Documented comprehensive patient assessments, treatment responses, and adverse events in compliance with organizational standards and regulatory requirements.”

Before: “Collaborated with interdisciplinary team.”

After: “Synthesized input from physicians, specialists, and allied health professionals to create cohesive care documentation ensuring accuracy and clinical consistency.”

Before: “Administered medications and monitored vital signs.”

After: “Evaluated patient responses to interventions and documented outcomes with attention to safety parameters and potential adverse reactions.”

Notice the pattern?

You’re not changing what you did. You’re reframing it to highlight the regulatory writing skills you were already using (documentation, compliance, synthesis, safety monitoring).

Focus on what you analyzed, synthesized, or documented, not just what tasks you completed.

Part #3: The Keywords Recruiters Are Searching For

Applicant Tracking Systems (ATS) are software programs that scan resumes for keywords before a human ever sees them. I don’t believe anyone can fully pass these systems.

But I know exactly what words recruiters search for when they’re looking for regulatory writers.

The principle:

Include these terms naturally throughout your resume:

• FDA

• protocols

• regulatory writing

• medical terminology

• clinical documentation

• adverse event reporting

• clinical study reports (CSRs)

• investigator brochures (IBs)

• GCP (Good Clinical Practice)

• ICH Guidelines (E3, E6, M11, M4)

For guidelines you’ve studied but not used professionally (like the ICH E3, E6, and M11 I walked you through), use this exact phrasing:

“Familiar with ICH E6(R3), E3, M11, and FDA submission requirements.”

This shows knowledge without overpromising experience. It’s a positioning strategy that works because it’s honest while demonstrating you’ve done your homework.

This exact keyword approach has helped me land 20+ lucrative pharma and biotech clients.

Part #4: Education, Certifications, and Memberships

Keep this section straightforward but strategic.

The principle:

List your degree, institution, and graduation date. If you have relevant coursework (pharmacology, research methods, biostatistics), include it.

Add AMWA membership if you have it. This signals you’re serious about the profession.

Include any certifications relevant to clinical research or medical writing (even if you’re working toward them).

One thing most people also forget. File format matters:

Submit as .docx unless specifically requested otherwise.

Use standard headings like “Professional Experience” and “Education” so recruiters can find what they need quickly.

---

Here’s What To Do This Week

Take one clinical task from your resume and reframe 3 bullet points using the examples above.

Focus on results and skills, not just tasks. Use regulatory keywords naturally. Show what you analyzed, synthesized, or documented.

Start with your most recent role. Rewrite 3 bullets to emphasize documentation, compliance, synthesis, or adverse event monitoring.

Don’t overthink it. Just apply the pattern you see in the examples.

Seeing one task transformed will give you momentum to finish the rest.

If you want the complete fill-in-the-blank resume template with examples for all 9 transferable skills, the exact keyword list recruiters search for, and the ‘familiar with’ positioning strategy for ICH guidelines, I’ve created the Regulatory Writing Resume Blueprint [$37]. It includes everything I used to go from a task-focused resume to one that got recruiter responses within 2 months, plus an EDMS study guide and video walkthrough.

I helped a burned-out ophthalmologist from Vanderbilt revamp her resume using this exact framework. She had a typical physician resume, but after we demonstrated how her research experience translated to regulatory writing, she landed interviews.

Within 60 days, she had her biotech role.

She’s still thriving there and sent me a thank-you note at the end of 2025.

Yours in Growth,

Keagen

P.S. Once your resume is ready, remember: never apply to jobs directly. Let recruiters become your advocate to hiring managers.