Senior Medical Writer-Full Time, Remote, Contract in Gene Editing Space
<p>KorInsight, Inc. is looking to hire a Senior Medical Writer who will help provide full-time, remote consulting services to our biopharmaceutical client partner in the gene therapy space.</p><p><br></p><p>Contract Duration: 6-month contract role, with opportunity to extend or convert to FTE</p><p><br></p><p>Weekly Hours: 40</p><p><br></p><p>Responsibilities will include but are not limited to the following:</p><ul><li>Write, review, and edit clinical regulatory documents such as study synopses, clinical study protocols, clinical study reports (CSRs), interim analyses, etc</li><li>Write, review, and edit regulatory and pre-clinical documents including briefing books, INDs, and related collateral documents</li><li>Critically assess and interpret statistical and clinical data</li><li>Help prepare for meetings with regulatory agencies</li><li>Work closely with cross-functional teams to ensure documents are high quality and that there is team alignment on their content and progress</li><li>Develop and carefully track timelines for document submission</li><li>Contribute to the development and implementation of medical writing best practices, policies, and SOPS to improve standards for authoring, reviewing, and finalizing documents</li></ul><p><br></p><p>Qualifications</p><ul><li>Advanced degree (M.S.) in relevant scientific discipline, Doctoral level degree (Ph.D., Pharm.D., or M.D.) preferred with minimum of 3-5 years of scientific or medical writing experience at a biotech/pharmaceutical company</li><li>Familiarity with current regulatory requirements and guidelines that affect medical writing</li><li>Excellent written and verbal communication skills</li><li>Scrupulous attention to detail</li><li>Ability to simplify complex information and present it in an engaging manner</li><li>Exceptional work ethic and organizational, time, and project management skills</li><li>Ability to foster relationships, build alignment, negotiate, and collaborate with cross-functional client partners</li><li>Ability to work independently with minimal supervision</li></ul><p><br></p>Industry<ul><li>Biotechnology</li></ul>Employment Type<p>Full-time</p>
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