Senior Medical Writer/Principal Medical Writer

Role overview

<p><strong><span data-contrast="auto"><span data-ccp-parastyle="Body Text">Position Summary:</span></span><span data-ccp-props="{"134245417":false,"201341983":0,"335559685":504,"335559739":0,"335559740":240,"335559991":504}">&nbsp;</span></strong></p> <p><span data-contrast="none">The Senior Medical Writer/Principal Medical Writer will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning, writing, editing/formatting, and performing QC review. Develops documents in compliance with Precision MW Style Guide, Precision SOPs, applicable regulatory guidelines (ie, ICH, FDA, GCP) and eCTD requirements. The successful candidate has a clear understanding of content requirements for key clinical documents based on regulatory requirements for all phases of development and will complete MW activities with impeccable attention to detail.</span><span data-ccp-props="{"201341983":0,"335559739":60,"335559740":240}">&nbsp;</span></p> <p><span style="text-decoration: underline;"><span data-contrast="none">Essential functions of the job include but are not limited to:</span><em><span data-contrast="none">&nbsp;</span></em> </span></p> <ul> <li><span data-contrast="none">Planning, writing, editing, formatting, and QC review of timely and high-quality clinical documents including clinical study protocols, IBs, ICF templates, DSURs, CSRs, CSR patient narratives with a clear understanding of content requirements based on regulatory guidance's&nbsp;