Medical Writer (Pharmaceutical)

Position: Medical Writer (Pharmaceutical)

Type: Contractor

Compensation: $30–$60/hour

Location: Remote

About the Opportunity 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, accurate, 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