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Job description
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.
Worksite address
statesville, NC, 28625, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.