Roles and ResponsibilitiesStrong experience with development and writing of nonclinical documents (e.g., 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 integrityAbility to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical dataAbility to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documentsInterpret 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 CMCDemonstrated ability to lead others to complete complex projectsAbility to complete documents according to sponsor's format, processes, and according to regulatory guidelinesAbility to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgmentOrganizational expert within the nonclinical subject areaExcellent written/oral communication and strong time and project management skillsAbility to attend regular team meetings, lead client meeting and CRMsAbility to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbarsStrong 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)RequirementsBS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/controlKnowledge of GLP, ICH guidelines, and applicable regulatory requirements2+ years of pharmaceutical regulatory nonclinical writing experienceStrong writing and analytical skillsProficiency with MS Office applicationsHands‑on experience with clinical trial and pharmaceutical development preferredBasic understanding of CROs and scientific & nonclinical data/terminology, & the drug development processSeniority levelEntry levelEmployment typeFull-timeJob functionInformation TechnologyIndustriesWireless Services, Telecommunications, and Communications Equipment ManufacturingReferrals increase your chances of interviewing at MMS by 2xGet notified about new Writer jobs in Denver, CO.#J-18808-Ljbffr. With a global footprint across four continents, MMS not only maintains an industry‑leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive.