Medical Writer (Pharmaceutical) - Remote
YO AI Labs · New York, United States · 1 mo ago
RemoteRemoteWritingContract
About the role
Remote contractor position for a Medical Writer (Pharmaceutical) supporting AI-assisted clinical documentation tools.
Responsibilities
- Author and review Clinical Study Reports, DSURs, PSURs/PBRERs, and related regulatory documents.
- Evaluate AI-generated content for scientific accuracy, structure, and regulatory compliance.
- Verify narrative claims against TFLs, protocols, and source data.
- Assess document organization, cross-referencing, and eCTD requirements.
- Provide clear, structured feedback to improve AI-generated clinical content.
- Collaborate with project teams to develop evaluation standards and best practices.
Qualifications
- 5+ years of regulatory medical writing experience in a sponsor, CRO, or consulting environment.
- Proven experience independently authoring or leading Clinical Study Reports.
- Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
- Ability to interpret clinical protocols, TFLs, and clinical data.
- Excellent written communication and analytical skills.
- Advanced degree in medicine, pharmacy, life sciences, or equivalent experience.
- Oncology or haematology experience is highly valued.
Skills
- Regulatory Medical Writing
- Clinical Study Report Authoring
- ICH E3 Guidelines
- Scientific Accuracy Assessment
- Source Data Verification
- Clinical Protocol Interpretation
- TFL Analysis
- Written Communication
- Structured Feedback
- Collaborative Problem-Solving
- AI-Assisted Documentation Evaluation
- ICH E2F / ICH E2C
- eCTD Knowledge
- Oncology & Haematology