Medical Writer - Remote
<strong>Job Title: Medical Writer Expert Remote<br><br></strong><strong>Location:</strong> Remote<br><br><strong>Job Type:</strong> Contractor<br><br><strong>Pay:</strong> $50–$80/hour<br><br><strong>Job Overview<br><br></strong>We are seeking an experienced <strong>Medical Writer / Clinical Document Author</strong> to develop, review, and evaluate clinical and regulatory documents while ensuring scientific accuracy, regulatory compliance, and high-quality medical writing.<br><br><strong>Key Responsibilities<br><br></strong><ul><li>Author and review Clinical Study Reports (CSRs) and other regulatory documents. </li><li>Interpret clinical protocols and ensure compliance with ICH guidelines. </li><li>Verify scientific accuracy using source data, TFLs (Tables, Figures, and Listings), and study documentation. </li><li>Review safety documentation, including DSURs and PSURs/PBRERs. </li><li>Provide structured feedback and collaborate with cross-functional teams. </li><li>Support AI-assisted documentation evaluation and quality improvement initiatives. <br><br><br></li></ul><strong>Required Skills<br><br></strong><ul><li>Regulatory Medical Writing </li><li>Clinical Study Report (CSR) Authoring </li><li>ICH E3 Guidelines </li><li>Scientific Accuracy Assessment </li><li>Source Data Verification </li><li>Clinical Protocol Interpretation </li><li>TFL Analysis </li><li>eCTD Knowledge </li><li>Strong Written Communication & Collaboration <br><br><br></li></ul><strong>Qualifications<br><br></strong><ul><li>5+ years of regulatory medical writing experience in a Sponsor, CRO, or consulting environment. </li><li>Experience authoring Clinical Study Reports and regulatory documentation. </li><li>Strong knowledge of ICH E3, ICH E2F, ICH E2C, and eCTD requirements. </li><li>Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field (MD, PharmD, PhD, or MSc). </li><li>Experience in oncology and haematology is preferred.</li></ul>