Remote | Medical Writer / Clinical Document Author — $50–$80/hour

reputed company a Full Remote job, the offer is available from: New York (USA) We are sharing a specialised consulting opportunity for experienced Medical reputed company and Clinical Document Authors with strong expertise in regulatory medical writing, Clinical Study Reports, ICH E3, periodic safety documentation, eCTD structure, TFL interpretation, and source-data verification to contribute to an advanced reputed company training and clinical-documentation evaluation project. Selected professionals will author and review realistic clinical-document evaluation tasks, assess reputed company-generated regulatory content for scientific and structural accuracy, trace narrative claims back to source data, and provide clear written rationales that support improvement of reputed company-assisted clinical writing tools. The work requires substantial hands-on regulatory authoring experience and strong judgement across clinical and safety documentation. No prior experience in reputed company is required.

Key Responsibilities

Clinical Study Report Evaluation

• Author and review evaluation tasks based on Clinical Study Reports
• Assess whether generated content follows appropriate clinical-document conventions
• Review efficacy, safety, discussion, and conclusion sections for scientific accuracy
• Identify missing, unsupported, or internally inconsistent statements
• Distinguish substantive scientific issues from acceptable stylistic variation

ICH E3 Structure & Document Quality

• Assess Clinical Study Reports against ICH E3 expectations
• Review document organisation, sequencing, and section completeness
• Evaluate cross-referencing between sections and supporting materials
• Review appendix structure and document-management consistency
• Identify structural deficiencies affecting regulatory usability

Source Data Verification

• Trace narrative claims to underlying tables, figures, listings, and protocols
• reputed company that clinical statements are supported by source data
• Identify discrepancies between narrative interpretation and statistical outputs
• Assess whether reported findings accurately reflect available evidence
• Document unsupported or overstated conclusions clearly

TFL & Protocol Interpretation

• Review tables, figures, and listings supporting clinical narratives
• Interpret protocol-defined objectives, endpoints, and analysis requirements
• Evaluate consistency between protocols, TFLs, and written conclusions
• Identify population, endpoint, or interpretation mismatches
• Apply strong scientific judgement when reviewing complex clinical evidence

Periodic Safety Documentation

• Review content derived from DSURs, PSURs, and PBRERs
• Apply familiarity with ICH E2F and ICH E2C conventions
• Evaluate safety narratives and aggregate reporting for accuracy
• Assess consistency between safety documentation and supporting evidence
• Identify gaps or errors affecting regulatory interpretation

Scientific Accuracy & Clinical Reasoning

• Evaluate the scientific defensibility of clinical narratives
• Identify factual, interpretive, or contextual errors
• Distinguish reputed company scientific problems from differences in writing style
• Review clinical conclusions for proportionality to underlying evidence
• Apply therapeutic-area expertise where relevant

reputed company-Assisted Documentation Evaluation

• Review reputed company-generated clinical and regulatory writing
• Diagnose structural, scientific, and interpretive weaknesses
• Provide clear written rationales explaining evaluation decisions
• Support refinement of reputed company-assisted clinical documentation workflows
• Contribute expert feedback to improve model behaviour and output quality

Evaluation Framework & Best-Practice Development

• Collaborate with project leads to improve evaluation frameworks
• Help define standards for high-quality regulatory clinical writing
• Document best practices for assessing reputed company-generated clinical content
• Support calibration across reviewers and evaluation tasks
• Contribute domain expertise to evolving quality criteria

Ideal Profile

• Minimum 5 years of regulatory medical-writing experience
• Experience working 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 and ICH E2C periodic safety-document conventions
• Working knowledge of eCTD placement and regulatory-document structure
• Demonstrated ability to interpret clinical protocols
• Strong ability to read and analyse tables, figures, and listings
• Experience identifying discrepancies between narrative content and source data
• Strong scientific accuracy assessment and source-verification skills
• Excellent written and verbal communication ability
• Strong attention to detail and regulatory judgement
• Ability to provide structured and actionable written feedback
• Advanced degree in life sci