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Remote Regulatory Writing Jobs in Sumter, SC (NOW HIRING)

micro1 AI

Medical Writing Manager

Columbia, SC · Remote

$50 - $80/hr

Remote micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

micro1 AI

Regulatory Affairs Specialist

Columbia, SC · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines ...

micro1 AI

Medical Billing Specialist

Columbia, SC · Remote

$50 - $80/hr

Remote micro1 is engaging Medical Writers / Clinical Document Authors to participate in a customer ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Veristat

Principal Medical Writer

Columbia, SC · On-site +1

  • Medical

  • Retirement

Minimum of 7 years of medical writing experience in a contract research organization or ... Advanced knowledge of ICH and related regulatory guidelines. Excellent written English and keen ...

micro1 AI

Compliance Officers

Columbia, SC · Remote

$50 - $70/hr

Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines ...

OLUSEGUN ORGANIZATION

Be Seen First

Remote Insurance Agent- No Experience Necessary!

Columbia, SC · Remote

$46K - $155K/yr

  • Medical

  • Dental

  • Life

Comply with insurance standards and regulations * Track and identify areas of improvement * Attend ... Excellent written and verbal communication skills * Ability to prioritize and multitask Company ...

micro1 AI

Director of Biostatistics

Columbia, SC · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... regulatory agencies (e.g., FDA, EMA) is a plus. * Excellent written communication skills and ...

micro1 AI

Biostatistician

Columbia, SC · Remote

$60 - $100/hr

Remote micro1 is engaging Biostatisticians to contribute to a customer's advanced project in AI ... regulatory agencies (e.g., FDA, EMA) is a plus. * Excellent written communication skills and ...

micro1 AI

AI Training Specialist - Chemistry

Columbia, SC · Remote

$70 - $90/hr

Remote micro1 is engaging Chemistry Specialists to participate in a project supporting a leading ... Collaborate and communicate effectively in written and verbal formats with project stakeholders ...

Veristat

Senior Project Manager

Columbia, SC · Remote

  • Medical

  • Life

  • Retirement

Flexible, inclusive culture - 70% remote workforce, 66% women-led teams * Learn more about our core ... other applicable regulatory rules and guidelines. * Proficiencyin English(written and verbal)

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All JobsRegulatory Writing JobsRemote Regulatory Writing JobsRemote Regulatory Writing Jobs in Sumter, SC

Remote Regulatory Writing information

See Sumter, SC salary details

$16

$35

$55

How much do remote regulatory writing jobs pay per hour?

As of Aug 18, 2026, the average hourly pay for remote regulatory writing in Sumter, SC is $35.24, according to ZipRecruiter salary data. Most workers in this role earn between $28.27 and $41.73 per hour, depending on experience, location, and employer.

What is remote regulatory writing?

Remote regulatory writing involves preparing and reviewing documents required for regulatory submissions to agencies like the FDA or EMA, such as clinical study reports, protocols, and investigator brochures. Regulatory writers ensure that all documents comply with industry standards and legal requirements, and they often work for pharmaceutical, biotech, or medical device companies. The 'remote' aspect means that professionals perform these tasks from home or another off-site location, using digital tools to collaborate with teams. This role requires strong scientific knowledge, attention to detail, and excellent written communication skills.

How do remote regulatory writers effectively collaborate with cross-functional teams while working from different locations?

Remote regulatory writers often collaborate with clinical, medical, and regulatory affairs teams spread across various regions. Effective communication is facilitated through regular video conferences, shared document platforms, and project management tools. While time zone differences can be a challenge, clear timelines and well-documented feedback processes help ensure everyone stays aligned. Building strong virtual relationships and being proactive in updates are key to maintaining seamless collaboration and delivering high-quality regulatory documents.

What are the key skills and qualifications needed to thrive as a remote regulatory writer, and why are they important?

To thrive as a Remote Regulatory Writer, you need strong scientific or medical writing expertise, attention to detail, and a background in life sciences or a related field, often supported by advanced degrees. Familiarity with regulatory submission platforms, document management systems, and guidelines such as ICH, FDA, and EMA requirements is essential. Excellent communication, time management, and the ability to work independently are crucial soft skills that set top performers apart. These competencies ensure accurate, compliant, and timely regulatory documentation crucial for product approvals and patient safety.

What is the difference between Remote Regulatory Writing vs Remote Medical Writing?

AspectRemote Regulatory WritingRemote Medical Writing
Required CredentialsLife sciences degree, regulatory affairs certifications (e.g., RAPS), scientific backgroundLife sciences or healthcare degree, medical or scientific background, writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory consulting firmsPharmaceutical, biotech, medical communications agencies, healthcare organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsClinical study reports, medical education materials, journal articles
Search & Comparison IntentOften compared for regulatory document creation rolesCompared for medical communication and scientific writing roles

Remote Regulatory Writing focuses on preparing documents for regulatory submissions and compliance, requiring regulatory knowledge and certifications. Remote Medical Writing involves creating scientific and medical content for various audiences, emphasizing medical knowledge and writing skills. While both roles involve scientific writing, their primary focus and industry applications differ.

What are popular job titles related to Remote Regulatory Writing jobs in Sumter, SC?

For Remote Regulatory Writing jobs in Sumter, SC, the most frequently searched job titles are:

What job categories do people searching Remote Regulatory Writing jobs in Sumter, SC look for?

The top searched job categories for Remote Regulatory Writing jobs in Sumter, SC are:

What cities near Sumter, SC are hiring for Remote Regulatory Writing jobs?

Cities near Sumter, SC with the most Remote Regulatory Writing job openings:

Remote Regulatory Writing jobs near you
Infographic showing various Remote Regulatory Writing job openings in Sumter, SC as of June 2026, with employment types broken down into 1% As Needed, 73% Full Time, 25% Part Time, and 1% Contract. Highlights an 83% Physical, 3% Hybrid, and 14% Remote job distribution, with an average salary of $73,300 per year, or $35.2 per hour.

Medical Writing Manager

micro1 AI

Columbia, SC • 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