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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, 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 documents, 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
2+ 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