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Medical Writing Consultant
<ul><li><strong>1099 QC Medical Writing Consultant – Remote</strong></li><li><strong>Schedule: Ad hoc / project-based</strong></li><li><strong>Hours: Variable — some weeks may have no hours or ~5 hours, while busier periods may require 30+ hours/week</strong></li><li><strong>Location:</strong> Remote</li><li><strong>Contract:</strong> 1099</li></ul><p><br></p><p>We are seeking an experienced QC Medical Writing Consultant to provide flexible, as-needed support for a pharmaceutical client. This is a remote 1099 contract with fluctuating hours based on project needs.</p><p><br></p><p><strong>What You’ll Do</strong></p><ul><li>Perform detailed QC reviews of clinical and regulatory documents</li><li>Review for accuracy, consistency, grammar, formatting, clarity, and adherence to established style guides/templates</li><li>QC documents such as CSRs, Investigator Brochures, clinical protocols, briefing documents, and regulatory submission documents</li><li>Verify consistency of data, tables, figures, references, terminology, and messaging across documents</li><li>Ensure documentation aligns with applicable FDA, EMA, ICH, and AMA standards</li><li>Work independently and meet sometimes fast-moving project timelines</li></ul><p><br></p><p><strong>What We’re Looking For</strong></p><ul><li>8+ years of medical writing/regulatory writing experience within the pharmaceutical/biotech industry</li><li>Strong hands-on experience performing QC of clinical and regulatory documents</li><li>Advanced knowledge of regulatory documentation and the drug development process</li><li>Excellent attention to detail with the ability to identify inconsistencies and errors</li><li>Strong knowledge of AMA style and FDA/EMA/ICH guidelines</li><li>Ability to work independently and flex hours based on changing project needs</li><li>Bachelor’s degree required; advanced scientific/clinical degree is a plus</li></ul>
