<p>The Position</p> <p>The Project Coordinator will support the nonclinical development of investigational drugs in the Arrowhead pipeline by assisting Toxicology staff in technical writing of toxicology-related documentation, conduct of internal and external toxicology studies, and support tasks. The ideal candidate will have excellent writing skills and be detail-oriented, responsive, and collaborative.</p> <p>Responsibilities</p> <ul> <li>Collaborate with Toxicology staff and cross-functional teams such as Regulatory Affairs, Medical Writing, Discovery Biology and Chemistry, DMPK, CMC, and Clinical Operations to prepare high-quality regulatory documentation for submission to global regulatory agencies </li><li>Draft, edit, and/or QC nonclinical development documents, including but not limited to, nonclinical study reports, investigator's brochures, integrated safety summaries, presentation materials, and IND and NDA applications </li><li>Organize toxicology data, reports, datasets, and documents for regulatory submissions and track documents through review cycles </li><li>Support internal exploratory toxicology studies with setup of the applicable systems, oversight of studies, and compilation of data </li><li>Assist Toxicologists with startup and oversight of GLP toxicology studies </li></ul> <p>Requirements</p> <ul> <li>Bachelor's Degree in Biology, Pharmacology/Toxicology, or related field </li><li>2+ years of pharmaceutical or scientific industry experience </li><li>Excellent written/oral communication and strong time and project management skills </li><li>Ability to independently and effectively operate in a fast-paced environment that requires collaboration, critical evaluation, and analytical judgment </li><li>Demonstrated proficiency with Microsoft Office applications </li></ul>