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Regulatory Writing Jobs in Raleigh, NC (NOW HIRING)

micro1 AI

Medical Writing Manager

Raleigh, NC · 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

Cary, NC · 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

Durham, NC · 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 ...

MMS

Senior Medical Writer (Remote)

Raleigh, NC · 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 ...

MMS

Nonclinical Writer

Raleigh, NC · On-site

Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory ...

ViiV Healthcare

Principal Medical Writer

Durham, NC · On-site

Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards. * Translate complex clinical and statistical data into clear ...

GlaxoSmithKline

Principal Medical Writer

Durham, NC · Remote

Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards. * Translate complex clinical and statistical data into clear ...

ViiV Healthcare

Principal Medical Writer

Durham, NC · Remote

Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards. * Translate complex clinical and statistical data into clear ...

GSK

Principal Medical Writer

Durham, NC · On-site

Manage end-to-end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards. * Translate complex clinical and statistical data into clear ...

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All JobsRegulatory Writing JobsRegulatory Writing Jobs in Raleigh, NC

Regulatory Writing information

See Raleigh, NC salary details

$15

$33

$141

How much do regulatory writing jobs pay per hour?

As of Aug 18, 2026, the average hourly pay for regulatory writing in Raleigh, NC is $33.63, according to ZipRecruiter salary data. Most workers in this role earn between $21.73 and $25.48 per hour, depending on experience, location, and employer.

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 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 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.

How much does a regulatory writing make?

Regulatory writers typically earn between $70,000 and $120,000 annually, depending on experience, location, and industry sector. Senior roles or those with specialized knowledge in areas like pharmaceuticals or biotech can command higher salaries, often supplemented by benefits and bonuses.

What does a regulatory writing do?

A regulatory writer creates and prepares documentation required for the approval of medical, pharmaceutical, or biotech products by regulatory agencies. They ensure that submissions such as clinical trial reports, safety updates, and product dossiers comply with industry standards and regulations, often using specialized tools and adhering to strict deadlines.

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 regulatory agency requirements. These documents are essential for obtaining approvals from agencies like the FDA or EMA and require precise, clear, and well-organized language. Regulatory writers often use specialized tools and adhere to strict formatting guidelines to ensure accuracy and consistency.

What are popular job titles related to Regulatory Writing jobs in Raleigh, NC?

For Regulatory Writing jobs in Raleigh, NC, the most frequently searched job titles are:

What job categories do people searching Regulatory Writing jobs in Raleigh, NC look for?

The top searched job categories for Regulatory Writing jobs in Raleigh, NC are:

Regulatory Writing jobs near you
Infographic showing various Regulatory Writing job openings in Raleigh, NC as of August 2026, with employment types broken down into 77% Full Time, 13% Part Time, and 10% Contract. Highlights an 75% In-person, and 25% Remote job distribution, with an average salary of $69,947 per year, or $33.6 per hour.

Medical Writing Manager

micro1 AI

Raleigh, NC • Remote

$50 - $80/hr

Part-time

Posted 14 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