MMS is hiring: Nonclinical Writer in Austin

Nonclinical Writer 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 an award-winning, data-focused clinical research organization (CRO) recognized for its exceptional culture and industry bests in employee retention. We support the pharmaceutical, biotech, and medical device industries with a proven scientific approach to complex trial data and regulatory submission challenges across four continents. This is a full-time, remote position. This person will participate in the development, writing, and management of highly technical nonclinical documents. 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, 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 alignment with current regulatory guidelines and 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 (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports) Collaborate with cross-functional teams such as project management, safety, efficacy, biostatistics, regulatory operations, and CMC Lead others to complete complex projects Produce documents according to sponsor’s format, processes, and regulatory guidelines Operate effectively in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Demonstrate organizational expert within the nonclinical subject area Communicate excellently written and oral, and possess strong time and project management skills Attend regular team meetings, lead client meetings and CRMs Work within various client systems (e.g., SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars Strong understanding of regulatory guidances as they apply to nonclinical submission documents and drug development (ICH, FDA, EMA, GLP, GCP, GMP, 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 and nonclinical data/terminology, and the drug development process #J-18808-Ljbffr