Clinical Document Author - Remote

Job Description

Job Description

Job Title: Medical Writer / Clinical Document Author

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.