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Regulatory Writing Jobs (NOW HIRING)

micro1 AI

Medical Writing Manager

Nashville, TN · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Anchorage, AK · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

New Haven, CT · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Austin, TX · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Kansas City, KS · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Chandler, AZ · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Arvada, CO · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Newport News, VA · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Saint George, UT · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Portland, OR · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Columbia, SC · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Lubbock, TX · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Gresham, OR · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Olathe, KS · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Lakeland, FL · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Palm Coast, FL · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Broken Arrow, OK · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Edinburg, TX · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Lafayette, LA · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

micro1 AI

Medical Writing Manager

Boulder, CO · Remote

$50 - $80/hr

Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant. * Direct experience independently authoring or leading the authoring of full Clinical ...

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All JobsRegulatory Writing Jobs

Regulatory Writing information

See salary details

$15

$34

$145

How much do regulatory writing jobs pay per hour?

As of Aug 14, 2026, the average hourly pay for regulatory writing in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.

What is an example of regulatory writing?

Regulatory writing involves creating documents such as clinical study reports, regulatory submission dossiers, or standard operating procedures that comply with industry standards and guidelines. These documents are used to support product approvals and require precise, clear, and compliant language, often utilizing tools like document management systems and adhering to regulations from agencies like the FDA or EMA.

What are some common challenges faced by regulatory writers in the industry?

Regulatory Writers often face tight deadlines and the need to manage complex, highly detailed documents that must comply with evolving regulatory requirements. They regularly coordinate input from diverse teams such as clinical, safety, and regulatory affairs, which can pose communication and alignment challenges. Staying current with changing international regulations and ensuring absolute accuracy in submissions are other common demands. However, these challenges also make the work engaging and offer opportunities to continuously learn and develop expertise in both scientific communication and regulatory affairs.

What are the key skills and qualifications needed to thrive in regulatory writing?

To thrive in Regulatory Writing, you need expertise in scientific or medical writing, an understanding of regulatory guidelines (such as FDA, EMA, or ICH), and typically a background in life sciences or related fields. Competence with document management systems, referencing tools like EndNote, and familiarity with submission platforms are often required. Strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams are key soft skills. These skills ensure the creation of accurate, compliant, and clear regulatory documents critical for drug and device approval processes.

What is regulatory writing?

A Regulatory Writing job involves creating and reviewing documents required for regulatory submissions in industries like pharmaceuticals, biotechnology, and medical devices. Regulatory writers ensure that documents comply with guidelines from regulatory agencies such as the FDA or EMA. Their work includes clinical study reports, investigator brochures, and regulatory submission dossiers. Strong writing skills, scientific knowledge, and attention to detail are essential for this role.

What does a regulatory writing do?

A regulatory writer creates and edits documents required for regulatory submissions to agencies such as the FDA or EMA, ensuring compliance with industry standards. They often work with technical data, use specialized tools, and have knowledge of regulatory guidelines to prepare clear, accurate, and complete documentation for product approval processes.
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Regulatory Writing jobs near you
Infographic showing various Regulatory Writing job openings in the United States as of August 2026, with employment types broken down into 79% Full Time, 13% Part Time, and 8% Contract. Highlights an 92% In-person, and 8% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.

Medical Writing Manager

micro1 AI

Nashville, TN • Remote

$50 - $80/hr

Part-time

Posted 10 days ago

Job description

Role Title: Medical Writer / Clinical Document Author


Role Type: Contractor


Location: Remote


micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer’s project focused on developing advanced AI-assisted writing tools for clinical documentation. In this role, you'll apply your expertise to help train next-generation AI systems. Your work will shape how models learn, reason, and perform through high-quality, real-world input. No prior experience in AI is required — your domain knowledge is what matters.


Scope of Work

  1. Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents to inform AI tool development.
  2. Apply expert judgment to assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
  3. Evaluate scientific accuracy in narrative sections such as efficacy, safety summaries, discussion, and conclusions, distinguishing true scientific or interpretive errors from stylistic differences.
  4. Trace narrative claims to source records—tables, figures, listings, and protocols—to verify that all assertions are appropriately supported.
  5. Provide clear and structured written rationales for each assessment, enabling precise diagnosis and improvement of AI model behavior.
  6. Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in the context of AI.


Preferred Qualifications

  1. Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
  2. Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
  3. Fluency with ICH E3 and conventions for periodic safety documentation (ICH E2F, ICH E2C) and eCTD placement.
  4. Demonstrated ability to read and interpret TFLs and protocol documents, identifying where narrative diverges from source data.
  5. Exceptional written and verbal communication skills, especially in providing structured, actionable feedback on clinical content.
  6. Advanced degree in life sciences, pharmacy, or medicine (PhD, PharmD, MD, MSc), or equivalent depth of authoring experience.
  7. Experience across multiple clinical phases and therapeutic areas; oncology and haematology expertise is especially valued.


Join our customer's team and leverage your authoring expertise to help design the next generation of AI-assisted clinical documentation solutions. This high-bar role offers you the chance to shape how tomorrow's writing teams draft and review regulatory documents — through your expert input, judgment, and real-world experience.

Apply