Medical Writer / Clinical Document - Remote

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.