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Remote Regulatory Medical Writer Jobs in Indiana

micro1 AI

Medical Writing Manager

Evansville, IN · Remote

$50 - $80/hr

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

micro1 AI

Medical Writing Manager

Fort Wayne, IN · Remote

$50 - $80/hr

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

micro1 AI

Medical Writing Manager

Fishers, IN · Remote

$50 - $80/hr

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

micro1 AI

Medical Writing Manager

Carmel, IN · Remote

$50 - $80/hr

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

micro1 AI

Medical Writing Manager

Indianapolis, IN · Remote

$50 - $80/hr

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

micro1 AI

Medical Writing Manager

South Bend, IN · Remote

$50 - $80/hr

Medical Writer / Clinical Document Author Role Type: Contractor Location: Remote micro1 is engaging ... Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent ...

Veristat

... range of regulatory documents and medical communications to support all phases of product ... Benefits vary by location and may include: o Remote working o Flexible time off o Paid holidays o ...

micro1 AI

Medical Billing Specialist

Fort Wayne, IN · 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

Medical Billing Specialist

Carmel, IN · 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

Medical Billing Specialist

South Bend, IN · 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

Medical Billing Specialist

Evansville, IN · 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

Medical Billing Specialist

Fishers, IN · 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

Medical Billing Specialist

Indianapolis, IN · 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

Fishers, IN · 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 ...

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Remote Regulatory Medical Writer information

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

AspectRemote Regulatory Medical WriterRemote Medical Writer
CredentialsMedical degree, regulatory writing experience, certifications (e.g., RAC)Medical, scientific, or related degree; writing experience
Work EnvironmentPharmaceutical/biotech companies, CROs, regulatory agenciesPharmaceutical, biotech, healthcare, or scientific organizations
Industry UsageRegulatory submissions, INDs, NDAs, safety reportsResearch publications, clinical trial documentation, scientific publications
Search/Comparison IntentRegulatory documentation, compliance, submission writingScientific writing, research, publication

The main difference is that Remote Regulatory Medical Writers focus on preparing regulatory documents for drug approvals and compliance, often requiring specific regulatory knowledge and certifications. Remote Medical Writers have a broader scope, including scientific publications and research documentation. Both roles require strong writing skills and relevant scientific backgrounds, but Regulatory Medical Writers specialize in regulatory submissions and compliance processes.

What are the most commonly searched types of Regulatory Medical Writer jobs in Indiana?

The most popular types of Regulatory Medical Writer jobs in Indiana are:

What are popular job titles related to Remote Regulatory Medical Writer jobs in Indiana?

For Remote Regulatory Medical Writer jobs in Indiana, the most frequently searched job titles are:

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The top searched job categories for Remote Regulatory Medical Writer jobs in Indiana are:

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Cities in Indiana with the most Remote Regulatory Medical Writer job openings:

Remote Regulatory Medical Writer jobs near you
Infographic showing various Remote Regulatory Medical Writer job openings in Indiana as of August 2026, with employment types broken down into 85% Full Time, and 15% Part Time. Highlights an 100% Remote job distribution.

Medical Writer / Clinical Document Author

micro1 AI

Indianapolis, IN • Remote

$50 - $80/hr

Part-time

Posted 17 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