Remote Regulatory Medical Writer - CSR & ICH Expert

24-MAG LLC; New York (NY); Remote; USD 41,000 - 83,000; Full time

Benefits offered by this job

Remote work

Job summary

24-MAG LLC seeks an experienced Medical Writer (Pharmaceutical) for a fully remote contract role focused on regulatory medical writing, CSR authoring, and AI-assisted evaluation of clinical documents. You will author and review CSR-related tasks, assess structure, and ensure scientific accuracy aligned with regulatory standards.

Ideal candidates have 5+ years in regulatory medical writing, CSR experience, and a strong ability to trace claims to source data; oncology/hematology experience is

Qualifications

• 5+ years of regulatory medical-writing experience at sponsor/CRO or as independent consultant.
• Direct experience independently authoring or leading full Clinical Study Reports.
• Strong working knowledge of ICH E3 and related guidelines.

Responsibilities

• Author and review evaluation tasks based on CSR and related regulatory documents.
• Assess document structure, sequencing, cross-referencing, and appendix organisation.
• Apply ICH E3 requirements and established regulatory-writing conventions.
• Review DSURs, PSURs/PBRERs, and other periodic safety documentation as relevant.
• Evaluate whether documentation meets clinical and regulatory standards.

Skills

Regulatory medical writing

CSR authoring

ICH E3

Scientific accuracy review

Source data verification

Education

Advanced degree in Life Sciences

Job description

24-MAG LLC seeks an experienced Medical Writer (Pharmaceutical) for a fully remote contract role focused on regulatory medical writing, CSR authoring, and AI-assisted evaluation of clinical documents. You will author and review CSR-related tasks, assess structure, and ensure scientific accuracy aligned with regulatory standards.

Ideal candidates have 5+ years in regulatory medical writing, CSR experience, and a strong ability to trace claims to source data; oncology/hematology experience is