Medical Writer
San Francisco, CA · On-site
About the Role We're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to ...
Medical Writer
San Francisco, CA · On-site
About the Role We're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to ...
Senior Director, Regulatory Science Communication
Princeton, NJ · On-site
$157K - $207K/yr
Provide leadership, coaching, and direction to internal writers, external vendors, and contract medical or regulatory writers as applicable. Qualifications and Preferred Skills * Advanced degree ...
Senior Director, Regulatory Science Communication
Princeton, NJ · On-site
$157K - $207K/yr
Provide leadership, coaching, and direction to internal writers, external vendors, and contract medical or regulatory writers as applicable. Qualifications and Preferred Skills * Advanced degree ...
Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic ...
Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic ...
Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals. Make an Impact at Veristat! Join a global team ...
Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals. Make an Impact at Veristat! Join a global team ...
Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals. Make an Impact at Veristat! Join a global team ...
Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals. Make an Impact at Veristat! Join a global team ...
Nonclinical Writer
Raleigh, NC · On-site
... regulatory submission challenges. With a global footprint across four continents, MMS not only ... This person will participate in the development, writing, and management of highly technical non ...
Quick apply
Nonclinical Writer
Raleigh, NC · On-site
... regulatory submission challenges. With a global footprint across four continents, MMS not only ... This person will participate in the development, writing, and management of highly technical non ...
Nonclinical Writer
Canton, MI · On-site
... regulatory submission challenges. With a global footprint across four continents, MMS not only ... This person will participate in the development, writing, and management of highly technical non ...
Quick apply
Nonclinical Writer
Canton, MI · On-site
... regulatory submission challenges. With a global footprint across four continents, MMS not only ... This person will participate in the development, writing, and management of highly technical non ...
Director, Regulatory Affairs - Infectious Disease
Berkeley Heights, NJ · On-site +1
$156K - $206K/yr
Excellent written and verbal communication skills, including regulatory writing and team communication. * Strong organizational, planning, and prioritization skills with high attention to detail.
Director, Regulatory Affairs - Infectious Disease
Berkeley Heights, NJ · On-site +1
$156K - $206K/yr
Excellent written and verbal communication skills, including regulatory writing and team communication. * Strong organizational, planning, and prioritization skills with high attention to detail.
Nonclinical Writer
Canton, MI · On-site
... regulatory submission challenges. With a global footprint across four continents, MMS not only ... This person will participate in the development, writing, and management of highly technical non ...
Nonclinical Writer
Canton, MI · On-site
... regulatory submission challenges. With a global footprint across four continents, MMS not only ... This person will participate in the development, writing, and management of highly technical non ...
The Medical Writer collaborates with members of cross-functional teams to prepare high-quality ... Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents ...
The Medical Writer collaborates with members of cross-functional teams to prepare high-quality ... Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents ...
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Quick apply
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Senior Medical Writer (Remote)
Canton, MI · On-site
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Quick apply
Senior Medical Writer (Remote)
Canton, MI · On-site
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Quick apply
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Quick apply
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Quick apply
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Quick apply
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Senior Medical Writer (Remote)
Miami, FL · On-site
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Quick apply
Senior Medical Writer (Remote)
Miami, FL · On-site
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Quick apply
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Quick apply
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Senior Medical Writer (Remote)
Boston, MA · On-site
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Quick apply
Senior Medical Writer (Remote)
Boston, MA · On-site
Highly proficient with styles of writing for various regulatory documents * Expert proficiency with ... client templates & style guides * Interact directly and independently with client to coordinate all ...
Regulatory Writer information
See salary details
$13.70 - $18.47
2% of jobs
$18.47 - $23.23
7% of jobs
$23.23 - $27.99
12% of jobs
$29.11 is the 25th percentile. Wages below this are outliers.
$27.99 - $32.76
16% of jobs
The median wage is $36.33 / hr.
$32.76 - $37.52
17% of jobs
$37.52 - $42.29
14% of jobs
$45.38 is the 75th percentile. Wages above this are outliers.
$42.29 - $47.05
11% of jobs
$47.05 - $51.81
10% of jobs
$51.81 - $56.58
5% of jobs
$56.58 - $61.34
3% of jobs
$61.34 - $66.11
3% of jobs
$13
$38
$66
How much do regulatory writer jobs pay per hour?
As of Aug 6, 2026, the average hourly pay for regulatory writer in the United States is $38.94, according to ZipRecruiter salary data. Most workers in this role earn between $28.85 and $47.12 per hour, depending on experience, location, and employer.
What are the key skills and qualifications needed to thrive as a regulatory writer, and why are they important?
To thrive as a Regulatory Writer, you need a solid background in life sciences or pharmacy, excellent writing skills, and a thorough understanding of regulatory guidelines. Familiarity with document management systems, medical writing software, and knowledge of ICH, FDA, and EMA requirements are typically required. Attention to detail, strong organizational skills, and the ability to communicate complex information clearly set outstanding candidates apart. These competencies ensure accurate, compliant, and timely documentation crucial for successful regulatory submissions in the pharmaceutical and biotech industries.
What is the difference between Regulatory Writer vs Medical Writer?
| Aspect | Regulatory Writer | Medical Writer |
|---|---|---|
| Credentials | Typically requires life sciences degree, regulatory affairs certifications | Often requires life sciences degree, medical or scientific writing experience |
| Work Environment | Pharmaceutical, biotech, or medical device companies, regulatory agencies | Pharmaceutical, healthcare, or academic research settings |
| Industry Usage | Used for preparing regulatory submission documents | Used for scientific publications, clinical study reports |
Regulatory Writers focus on creating documents for regulatory submissions, ensuring compliance with industry standards. Medical Writers produce scientific content for publications, clinical reports, and educational materials. While both roles require scientific expertise, Regulatory Writers specialize in regulatory documentation, whereas Medical Writers focus on scientific communication and publication.
What is a regulatory writer?
Regulatory writers are professionals who prepare documents required for the approval, registration, and maintenance of pharmaceutical, biotechnology, or medical device products. They create clear, accurate materials such as clinical study reports, regulatory submissions, and summaries for agencies like the FDA or EMA. These writers ensure that documents comply with regulatory guidelines and help communicate complex scientific information in an understandable way. Their work is crucial for bringing new medical products to market and maintaining compliance throughout a product’s lifecycle.
How much does a regulatory writer make?
A regulatory writer typically earns between $60,000 and $100,000 annually, depending on experience, industry, and location. Senior regulatory writers or those with specialized knowledge in areas like pharmaceuticals or healthcare may earn higher salaries, often supplemented by certifications and strong technical writing skills.
What are some typical challenges faced by regulatory writers when preparing submission documents?
Regulatory Writers often encounter challenges such as interpreting complex scientific data and ensuring it meets stringent regulatory guidelines. They must coordinate input from multidisciplinary teams, manage tight timelines, and adapt to evolving regulations across different regions. Effective communication and attention to detail are crucial, as even minor inconsistencies can delay regulatory approvals. Collaboration with subject matter experts and project managers is a key part of the process to ensure accuracy and compliance.
More about Regulatory Writer jobs
What cities are hiring for Regulatory Writer jobs? Cities with the most Regulatory Writer job openings:
What are the most commonly searched types of Regulatory Writer jobs? The most popular types of Regulatory Writer jobs are:
What states have the most Regulatory Writer jobs? States with the most job openings for Regulatory Writer jobs include:
What job categories do people searching Regulatory Writer jobs look for? The top searched job categories for Regulatory Writer jobs are:
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Re-posted yesterday
Job description
About Collate
Collate is an AI document generation platform for life sciences. We automate paperwork with AI, helping our customers get life-saving innovations to patients years faster. Collate is an end-to-end solution, powering every step of drug, diagnostic, and medical device development-from concept to market.
Our CEO Surbhi Sarna is a former General Partner at Y Combinator. Surbhi founded nVision Medical, which developed a new method to detect ovarian cancer and was acquired by Boston Scientific. Our CTO Nate Smith is a former Visiting Partner at Y Combinator and founder of Lever. Our AI researchers, engineers, and designers have worked at Google, Nvidia, Meta, Netflix, Amazon, AirBnB, Hippocratic AI, and Grail, and 40% of our team are former founders.
We're an elite team, with $125M in funding from top investors (Redpoint, First Round Capital, CRV, Conviction, Y Combinator) and leaders in healthcare and AI. This is a rare chance to join an early-stage company with world-changing potential, experienced founders, and resources to execute at scale.
About the RoleWe're looking for an experienced regulatory medical writer to act as our in-house pharma subject matter expert on a consulting basis. You'll work directly with our engineering team to shape how our AI generates, reviews, and formats regulatory documents. This isn't a "review documents in isolation" role - you'll be embedded in tight iteration loops with engineers, giving real-time feedback that directly shapes what we build next.
What You'll Do
Review AI-generated regulatory documents produced via Collate for accuracy, format, and regulatory voice/tone
Advise on regulatory document lifecycle workflows - how documents actually move through pharma companies in practice, including handoffs, review cycles, and approval chains
Provide usability feedback on Collate from the perspective of a working RA professional / medical writer - what feels off, what's missing, what would make you trust and adopt a tool like this
Advise on submission-readiness standards to help inform our product requirements and the quality benchmarks we hold our AI-generated output to
Serve as a pharma insider resource - helping us understand org structures, roles, timelines, and internal processes at target pharma companies, and weighing in on industry relationships and positioning (e.g., which pharma leaders and functions we should be building relationships with)
How We'll Work Together
You'll partner directly with engineers, not just submit written feedback - expect short, iterative cycles where your input shapes a prompt change or feature the same week
Early on, your feedback will be translated into product changes by the engineering team.
You'll also be looped in as a pharma SME beyond document review - for example, helping us think through which pharma leaders or functions to prioritize for relationship-building and industry engagement
What We're Looking For
Experience as a medical writer and/or regulatory affairs professional in pharma or biotech, with hands-on experience preparing or reviewing regulatory submissions (e.g., IND, NDA/BLA, CTD modules, clinical study reports, briefing documents)
Strong grasp of global regulatory document standards, formatting conventions, and submission-readiness expectations (FDA and/or EMA)
Familiarity with how regulatory documents move through review, approval, and sign-off inside a pharma organization
Comfort giving direct, specific feedback in a fast-moving, iterative product environment - this is a "work alongside engineers" role, not a "hand off a redline" role
Genuine curiosity about AI tools and how they can (and can't yet) support regulatory writing
Bonus: existing network or relationships across regulatory affairs, medical writing, or pharma leadership circles
Why Join Collate?
Impact: Build systems and experiences that touch real patients and providers, improving healthcare outcomes.
Ownership: Shape both our product experience and our engineering culture from the start.
Learning: Collaborate with a uniquely interdisciplinary team-AI researchers, healthcare leaders, and experienced startup builders.
Upside: Join a company early enough to have meaningful equity and career-defining impact.
The base salary range for this role is competitive, depending on experience and level (Tier 1, San Francisco)
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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