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Reviewing against: Sr Medical Writer - Sponsor-dedicated at Syneos HealthBack to job

<h2>Responsibilities</h2>
<ul>
<li>Lead medical writing deliverables, ensuring scientific information is clear and accurate</li>
<li>Manage medical writing activities for individual studies with minimal supervision</li>
<li>Lead resolution of client comments</li>
<li>Author protocols, clinical study reports, patient narratives, IBs, IND/NDA submissions, and manuscripts</li>
<li>Adhere to ICH E3, SOPs, client standards and templates</li>
<li>Coordinate quality and editorial reviews and peer review internal documents</li>
<li>Review statistical analysis plans and TLF specifications</li>
<li>Mentor less experienced medical writers</li>
</ul>
<h2>Requirements</h2>
<ul>
<li>3-5 years of relevant science, technical or medical writing experience</li>
<li>Experience in biopharmaceutical, device or CRO industry</li>
<li>Strong understanding of FDA and ICH regulations</li>
<li>Experience writing relevant regulatory document types</li>
<li>Extensive English grammar knowledge and AMA Manual of Style familiarity</li>
</ul>
<h2>About the Company</h2>
<p>Syneos Health is a fully-integrated life sciences services organization partnering with innovators across drug development and commercialization.</p>

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