Nonclinical Writer Job at MMS in Toledo

Join to apply for the Nonclinical Writer role at MMS . Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). With a global footprint across four continents, MMS maintains an industry‑leading customer satisfaction rating and fosters a collaborative and inclusive work environment where employees can thrive. This is a full‑time, remote position. Roles and Responsibilities Strong 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, leading the writing (structure, content and messaging) of nonclinical documents, ensuring the nonclinical package aligns with current regulatory guidelines and meets scientific integrity Author based on highly technical sources such as GLP and non‑GLP nonclinical study reports, in vivo and in vitro nonclinical data Develop a mapping plan for the placement of nonclinical studies within the structure of Module 2.4 and 2.6 eCTD submission documents Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (e.g., 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 Complete documents according to sponsor’s format, processes, and regulatory guidelines Operate effectively in an environment requiring negotiation, persuasion, collaboration, and analytical judgment Serve as an organizational expert within the nonclinical subject area Exhibit excellent written and oral communication and strong time and project management skills Attend regular team meetings, lead client meetings and CRMs Work in various client systems (e.g., SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars Have a strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (e.g., 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 #J-18808-Ljbffr