Remote - Medical Writer (Pharmaceutical) - $30-$60/hour

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

About the job Remote | Medical Writer (Pharmaceutical) - $30-$60/hour

We are sharing a specialised consulting opportunity for experienced Medical Writers with strong expertise in regulatory medical writing, Clinical Study Report authoring, ICH guidelines, scientific accuracy assessment, source-data verification, and clinical-document evaluation to contribute to an advanced AI training and clinical-writing project.

Selected professionals will author and review realistic evaluation tasks based on clinical and regulatory documents, assess AI-generated content for structural and scientific accuracy, trace narrative claims to source data, and provide structured feedback grounded in professional medical-writing standards. No prior experience in AI is required.

Key Responsibilities

Clinical & Regulatory Document Review

• Author and review evaluation tasks based on Clinical Study Reports 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 where relevant
• Evaluate whether documentation meets expected clinical and regulatory standards

Scientific Accuracy & Clinical Interpretation

• Assess efficacy, safety, discussion, and conclusion sections for scientific accuracy
• Distinguish substantive scientific errors from acceptable stylistic differences
• Evaluate whether interpretations are supported by the underlying clinical evidence
• Identify inconsistencies, overstatements, or unsupported conclusions
• Apply expert judgement across varied clinical and therapeutic contexts

Source Data & TFL Verification

• Trace narrative claims to tables, figures, listings, protocols, and supporting records
• Verify that clinical assertions are accurately grounded in source data
• Identify discrepancies between narrative content and underlying TFLs
• Review protocol requirements when assessing clinical-document accuracy
• Document unsupported or incorrectly interpreted source information clearly

AI Content Evaluation & Feedback

• Review AI-generated clinical writing for accuracy, completeness, and structural compliance
• Provide clear written rationales explaining evaluation decisions
• Identify recurring model errors or areas requiring improved clinical reasoning
• Distinguish content-quality issues from formatting or stylistic preferences
• Deliver structured and actionable feedback supporting model improvement

Evaluation Frameworks & Collaboration

• Collaborate with project leads to refine clinical-writing evaluation frameworks
• Help define best practices for AI-assisted regulatory documentation review
• Contribute expertise across clinical phases and therapeutic areas
• Support consistent evaluation standards across regulatory-writing tasks
• Communicate complex clinical-document issues clearly to multidisciplinary stakeholders

Ideal Profile

• 5+ years of regulatory medical-writing experience at a sponsor, CRO, or as an independent consultant
• Direct experience independently authoring or leading full Clinical Study Reports
• Strong working knowledge of ICH E3
• Familiarity with ICH E2F, ICH E2C, and periodic safety documentation
• Knowledge of eCTD structure and document placement
• Demonstrated ability to interpret clinical protocols and TFLs
• Strong experience verifying narrative claims against source data
• Excellent written and verbal communication skills
• Ability to provide structured, precise, and actionable clinical feedback
• Advanced degree in life sciences, pharmacy, medicine, or a related field is highly valuable
• Experience across multiple clinical phases and therapeutic areas is advantageous
• Oncology and haematology expertise is especially valued
• No prior AI-training or model-evaluation experience is required

Engagement Details

• Independent contractor engagement
• Fully remote
• Compensation: $30-$60/hour
• Work will involve Clinical Study Report evaluation, regulatory medical writing, TFL analysis, protocol interpretation, scientific-accuracy review, and AI-assisted documentation assessment
• Assignments may involve CSRs, DSURs, PSURs/PBRERs, clinical protocols, tables, figures, listings, and related regulatory materials
• Strong ICH E3 knowledge and independent CSR-authoring experience are central to this engagement
• Oncology and haematology experience is particularly valuable
• Project scope, workload, document types, therapeutic areas, and evaluation standards may evolve depending on project requirements
• Work must be completed without using confidential, proprietary, patient-identifiable, or unpublished clinical information belonging to any employer, sponsor, CRO, healthcare organisation, institution, or other third party

About the Platform

This opportunity is available through 24-MAG LLC. We connect experienced professionals with remote consulting opportunities across technical, evaluation, and project-based workstreams.