Medical Writer – Remote

RemoteJobsOne; Kentucky; Remote; USD 41,000 - 83,000; Full time

Job summary

RemoteJobsOne is actively seeking a Medical Writer (Pharmaceutical) to work remotely on a contractor basis. The role focuses on developing AI-assisted tools for clinical documentation, leveraging extensive regulatory writing experience to shape how AI models learn and produce regulatory content.

Requires expertise in CSR authoring and ICH guidelines, with strong attention to source data and narrative accuracy.

Qualifications

• Minimum 5 years of regulatory medical writing experience with sponsor/CRO/consultant.
• Experience authoring full Clinical Study Reports (CSR).
• Fluency with ICH E3 and periodic safety documentation (ICH E2F/E2C) and eCTD placement.
• Ability to read and interpret TFLs and protocol documents.
• Experience across multiple clinical phases; oncology/haematology valued.

Responsibilities

• Author and review CSRs and related clinical documents for AI tool development.
• Assess AI-generated content against clinical templates and ICH structure.
• Evaluate narrative accuracy in efficacy, safety summaries, discussions and conclusions.
• Trace narrative claims to source records to verify support.
• Provide structured, written rationales for assessments to guide AI model improvements.
• Collaborate with project leads to refine evaluation frameworks and best practices.

Skills

Regulatory medical writing

Clinical documentation

Interpretation of clinical data

Education

Advanced life sciences degree

Job description

This is a fully remote position, open to candidates based in 55 countries, including United States, United Kingdom, Canada, Germany, India, France, Netherlands, Singapore.

Pay: $30–$60/hr

Role Title: Medical Writer (Pharmaceutical)

Role Type: Contractor

Location: Remote

We are 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.