Medical Writer (Pharmaceutical)

Position: Medical Writer (Pharmaceutical)

Type: Contractor

Compensation: $30–$60/hour

Location: Remote

About the Chance micro1 is engaging experienced Medical Writers and Clinical Document Authors to support a customer project focused on developing advanced AI-assisted clinical documentation tools .

Selected contributors will apply their expertise in regulatory medical writing, Clinical Study Reports, periodic safety documentation, clinical data interpretation, and pharmaceutical documentation standards to evaluate and improve AI-generated clinical content. Your work will help train and evaluate next-generation AI systems using high-quality, real-world regulatory writing expertise.

Prior AI experience is not required. The primary qualification is strong professional experience in pharmaceutical medical writing and clinical documentation.

Responsibilities

- Author and review realistic evaluation tasks based on Clinical Study Reports (CSRs), DSURs, PSURs/PBRERs , and related clinical documents.
- Evaluate whether AI-generated clinical content meets required templates, structural conventions, and regulatory documentation standards .
- Assess AI-generated documents for appropriate ICH E3 organization, section sequencing, cross-referencing, and appendix management .
- Evaluate scientific accuracy in clinical narrative sections, including:
- Efficacy summaries
- Safety summaries
- Discussion
- Conclusions
- Distinguish substantive scientific or interpretive errors from acceptable stylistic differences.
- Trace narrative claims back to source materials, including tables, figures, listings (TFLs), and clinical protocols , to verify that statements are appropriately supported.
- Identify discrepancies between narrative content and underlying clinical data or source documentation.
- Provide clear, structured, and actionable written rationales explaining assessment decisions.
- Collaborate with project leads to refine evaluation frameworks and establish best practices for regulatory medical writing in AI-assisted documentation.




- Apply professional judgment to ensure AI-generated clinical documents are scientifically accurate, structurally appropriate, and consistent with regulatory expectations.

Required Qualifications

- Minimum 5 years of professional regulatory medical writing experience at a pharmaceutical sponsor, CRO, or as an independent consultant.
- Direct experience independently authoring or leading the development of full Clinical Study Reports , beyond summaries or partial contributions.
- Strong working knowledge of ICH E3 and clinical study report conventions.
- Familiarity with periodic safety documentation requirements, including ICH E2F and ICH E2C .
- Understanding of eCTD (Electronic Common Technical Document) structure and document placement.
- Demonstrated ability to read and interpret Tables, Figures, and Listings (TFLs) and clinical protocol documents.
- Ability to identify discrepancies between clinical source data and narrative interpretation.
- Exceptional written and verbal communication skills.
- Strong ability to provide structured, precise, and actionable feedback on complex clinical content.
- Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field , such as:
- PhD
- PharmD
- MD
- MSc
- Or equivalent depth of professional medical-writing experience
- Experience working across multiple clinical phases and therapeutic areas.

Preferred Qualifications

- Extensive experience authoring and reviewing regulatory clinical documents across multiple sponsors or CRO environments.
- Strong expertise in oncology and/or haematology .
- Experience reviewing AI-generated or technology-assisted clinical documentation.
- Experience developing clinical writing standards, templates, review frameworks, or quality-control processes.




- Familiarity with AI-assisted medical writing, clinical documentation automation, or AI evaluation.
- Experience collaborating with cross-functional clinical, regulatory, statistical, and medical teams.
- Strong understanding of clinical development and regulatory submission workflows.

Key Areas of Expertise

- Regulatory Medical Writing
- Clinical Study Reports
- CSR Authoring
- DSUR
- PSUR
- PBRER
- ICH E3
- ICH E2F
- ICH E2C
- eCTD
- Clinical Documentation
- Clinical Protocol Interpretation
- TFL Analysis
- Tables, Figures & Listings
- Scientific Accuracy Assessment
- Clinical Data Interpretation
- Efficacy Reporting
- Safety Reporting
- Regulatory Documentation
- Oncology
- Haematology
- AI-Assisted Medical Writing
- AI Content Evaluation
- Source Data Verification
- Structured Feedback
- Clinical Quality Assurance

Compensation & Engagement

- Compensation: $30–$60/hour
- Engagement Type: Contractor
- Work Arrangement: Fully remote
- Project Focus: AI-assisted clinical documentation, regulatory medical writing, and clinical content evaluation
- Primary Domains: Clinical Study Reports, periodic safety documentation, regulatory writing, and clinical data interpretation
- AI Experience: Prior AI experience is not required
- Openings: Approximately 30 positions
- Work Style: Expert-led, project-based evaluation and documentation work

Application Process

1. Submit your application with your resume and relevant regulatory medical-writing experience.
2. Demonstrate at least 5 years of professional regulatory medical-writing experience .
3. Provide evidence of independently authoring or leading full Clinical Study Reports.
4. Demonstrate knowledge of ICH E3, ICH E2F, ICH E2C, eCTD , and clinical documentation standards.
5. Highlight experience interpreting TFLs, protocols, and clinical source data.
6. Complete any required medical-writing or clinical-document evaluation.
7. Complete onboarding if selected.
8. Begin contributing expert medical-writing judgment to AI-assisted clinical documentation and evaluation workflows.

📌 Medical Writer (Remote | ) (Canada)
🏢 Synthires
📍 Canada