Medical Writer - Remote

YO AI Labs; San Jose (CA); Remote; USD 69,000 - 110,000; Part time

Job summary

YO AI Labs seeks an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy and regulatory compliance.

The role involves authoring CSRs, interpreting protocols, verifying data, reviewing safety documents like DSURs/PSURs, and collaborating with cross-functional teams; remote contractor role with AI-assisted documentation quality initiatives.

Qualifications

• 5+ years of regulatory medical writing in a Sponsor, CRO, or consulting environment.
• Experience authoring Clinical Study Reports and regulatory documentation.
• Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.
• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field (MD, PharmD, PhD, or MSc).
• Experience in oncology and haematology is preferred.

Responsibilities

• Author and review Clinical Study Reports (CSRs) and other regulatory documents.
• Interpret clinical protocols and ensure compliance with ICH guidelines.
• Verify scientific accuracy using source data, TFLs (Tables, Figures, and Listings), and study documentation.
• Review safety documentation, including DSURs and PSURs/PBRERs.
• Provide structured feedback and collaborate with cross-functional teams.
• Support AI-assisted documentation evaluation and quality improvement initiatives.

Skills

Regulatory Medical Writing

CSR Authoring

ICH E3 Guidelines

Scientific Accuracy Assessment

Source Data Verification

Clinical Protocol Interpretation

TFL Analysis

eCTD Knowledge

Written Communication

Education

Advanced degree in Life Sciences, Pharmacy, Medicine, or related field (MD, PharmD, PhD, MSc)

Job description

Job Title: Medical Writer Expert Remote

Location: Remote
Job Type: Contractor
Pay: $50–$80/hour

Job Overview

We are seeking an experienced Medical Writer / Clinical Document Author to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy, regulatory compliance, and high-quality medical writing.

Key Responsibilities

• Author and review Clinical Study Reports (CSRs) and other regulatory documents.

• Interpret clinical protocols and ensure compliance with ICH guidelines.

• Verify scientific accuracy using source data, TFLs (Tables, Figures, and Listings), and study documentation.

• Review safety documentation, including DSURs and PSURs/PBRERs.

• Provide structured feedback and collaborate with cross-functional teams.

• Support AI-assisted documentation evaluation and quality improvement initiatives.

Required Skills

• Regulatory Medical Writing

• Clinical Study Report (CSR) Authoring

• ICH E3 Guidelines

• Scientific Accuracy Assessment

• Source Data Verification

• Clinical Protocol Interpretation

• TFL Analysis

• eCTD Knowledge

• Strong Written Communication & Collaboration

Qualifications

• 5+ years of regulatory medical writing experience in a Sponsor, CRO, or consulting environment.

• Experience authoring Clinical Study Reports and regulatory documentation.

• Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements.

• Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field (MD, PharmD, PhD, or MSc).

• Experience in oncology and haematology is preferred.