CONTRACTORRemoteActive
Medical Writer (Pharmaceutical)
Support a customer project focused on developing advanced AI-assisted writing tools for clinical documentation. Author and review evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents; assess AI-generated content for regulatory structure and scientific accuracy; verify narrative claims against source data; and provide structured feedback to improve AI model performance.
Salary
USD30 - USD60 / hour
Department
Regulatory Medical Writing & AI Evaluation
Experience
Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant, including direct experience authoring or leading full Clinical Study Reports
Curated by Farooq77 Jobs
Role fit snapshot
- Engagement
- Remote contractor | micro1 application platform
- Experience
- Minimum recorded experience: Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant, including direct experience authoring or leading full Clinical Study Reports
- Core expertise
- Regulatory Medical Writing & AI Evaluation | Regulatory Medical Writing | Clinical Study Report Authoring | ICH E3 Guidelines
- Expected work/output
- Evaluation tasks
- Geographic eligibility
- Not specified beyond Remote
- Listing dates
- Posted 2026-09-23 | Valid through 2026-10-23
- Compensation
- Recorded compensation: $30-$60/hour
Responsibilities
- Author and review realistic evaluation tasks based on Clinical Study Reports, DSURs, PSURs/PBRERs, and related clinical documents.
- Assess whether AI-generated content fulfills clinical template and structural requirements, including ICH E3 organization, section sequencing, cross-referencing, and appendix management.
- Evaluate scientific accuracy in efficacy, safety summaries, discussion, and conclusion sections.
- Distinguish genuine scientific or interpretive errors from stylistic differences.
- Trace narrative claims to tables, figures, listings, protocols, and other source records to verify supporting evidence.
- Provide clear and structured written rationales for each assessment.
- Collaborate with project leads to refine evaluation frameworks and document best practices for clinical regulatory writing in AI-assisted workflows.
Skills
Regulatory Medical WritingClinical Study Report AuthoringICH E3 GuidelinesScientific Accuracy AssessmentSource Data VerificationClinical Protocol InterpretationTFL AnalysisTables Figures ListingsWritten CommunicationStructured FeedbackCollaborative Problem-SolvingAI-Assisted Documentation EvaluationICH E2FICH E2CPeriodic Safety DocumentationDSURPSURPBREReCTDClinical DocumentationClinical Data InterpretationOncologyHaematology
Requirements
- Minimum 5 years of regulatory medical writing experience at a sponsor, CRO, or as an independent consultant.
- Direct experience independently authoring or leading the authoring of full Clinical Study Reports, beyond summaries or partial contributions.
- Fluency with ICH E3 and conventions for periodic safety documentation under ICH E2F and ICH E2C.
- Knowledge of eCTD placement and clinical regulatory documentation conventions.
- Ability to read and interpret tables, figures, listings, and protocol documents and identify divergence between narrative and source data.
- Exceptional written and verbal communication skills, particularly for providing structured and actionable feedback.
- Advanced degree in life sciences, pharmacy, or medicine such as PhD, PharmD, MD, or MSc, or equivalent depth of authoring experience.
- Experience across multiple clinical phases and therapeutic areas.
- Oncology and haematology expertise is especially valued.
Benefits
- Fully remote contractor opportunity.
- Compensation of $30–$60 per hour.
- Opportunity to contribute regulatory medical writing expertise to next-generation AI systems.
- No prior AI experience required.
- Opportunity to help shape AI-assisted clinical documentation and regulatory writing tools.
Before you apply
- Confirm that your location is eligible for the role.
- Confirm the employment or contract type.
- Verify the current compensation at the official source.
- Review the required skills and experience.
- Check that the listing is still open before applying.
- Never pay a fee to submit a job application.