MMS is hiring: Nonclinical Writer in Boston

Nonclinical Writer – MMS Join to apply for the Nonclinical Writer role at MMS . This is a full-time remote position. 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) that prides itself on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. 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. Visit www.mmsholdings.com or follow MMS on LinkedIn for more exciting opportunities and why MMS is a great place to advance your career. 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; lead the writing (structure, content, and messaging) of nonclinical documents, ensuring the package aligns with current regulatory guidelines and meets scientific integrity Author documents 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 Effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment Excel as an organizational expert within the nonclinical subject area Possess excellent written/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 Strong understanding of regulatory guidances as they apply 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, chemistry, or a related field, with industry experience in 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, and the drug development process Referrals increase your chances of interviewing at MMS by 2x. #J-18808-Ljbffr