Senior Nonclinical Writer (US)

This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, 1st Edition Investigator's Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs). • Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical submission documents for INDs/CTAs/NDAs/BLAs/MAAs, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity. • Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data. • Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents. • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports). • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC. • Demonstrated ability to lead others to complete complex projects. • Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines. • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment. • Organizational expert within the nonclinical subject area. • Excellent written/oral communication and strong time and project management skills. • Ability to attend regular team meetings, lead client meeting and CRMs. • Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars. • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP). Requirements: • BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control. • Knowledge of GLP, ICH guidelines, and applicable regulatory requirements. • 5+ years of pharmaceutical regulatory nonclinical writing experience. • Strong writing and analytical skills. • Proficiency with MS Office applications. • Hands-on experience with clinical trial and pharmaceutical development preferred. • Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process.