Nonclinical Writer Role at MMS USA
MMS is hiring a Nonclinical Writer in Canton, MI! This full-time, remote biology job offers the chance to develop and manage technical nonclinical documents while working in a supportive, innovative CRO environment. Join MMS and advance your career in pharmaceutical and biotech regulatory writing.
Job Details:
- Job Title: Nonclinical Writer
- Location: Canton, MI (Remote)
- Industry: Pharmaceutical, Biotech, and Medical Devices
- Job Type: Full-time
- Experience Required: 2+ years in pharmaceutical regulatory nonclinical writing
- Key Skills: Regulatory writing, eCTD submission, GLP, ICH guidelines
About MMS:
MMS is an award-winning, data-focused clinical research organization (CRO) with a global footprint across four continents. Recognized as a Great Place to Work, MMS supports the pharmaceutical, biotech, and medical device industries with scientific approaches to complex trial data and regulatory submission challenges. MMS fosters an inclusive, collaborative environment, maintaining industry-leading customer satisfaction and employee retention rates. Explore more Biology job offers.
Educational Requirements:
- BS+ in toxicology, biology, or related field
- Industry experience in regulatory writing, regulatory affairs, laboratory sciences, or quality assurance/control
- Knowledge of GLP, ICH guidelines, and applicable regulatory requirements
Key Responsibilities for Nonclinical Writer Role:
- Develop and write nonclinical documents including Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure (IB), Nonclinical Study Reports, Meeting Requests, Briefing Documents, and RTQs
- Lead projects independently and ensure alignment with regulatory guidelines and scientific integrity
- Author content from technical sources like GLP/non-GLP study reports, in vivo/in vitro nonclinical data
- Develop mapping plans for nonclinical studies in Module 2.4 and 2.6 submissions
- Interpret pharmacokinetics, pharmacology, and toxicology data (e.g., Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports)
- Collaborate with cross-functional teams including project management, safety, efficacy, biostats, regulatory operations, and CMC
- Lead others to complete complex projects and meet sponsor formatting and regulatory requirements
- Operate effectively in negotiation, collaboration, and analytical judgment scenarios
Skills Required for Nonclinical Writer Role:
- Strong writing and analytical skills
- Excellent oral and written communication
- Proficiency in MS Office and client systems (e.g., SharePoint, Veeva RIM, PleaseReview, EndNote)
- Understanding of CROs, scientific/nonclinical data, and drug development processes
- Knowledge of regulatory guidelines (ICH, FDA, EMA) and good laboratory practices (GLP, GCP, GMP, GDP)
Benefits of the Role for Nonclinical Writer Role:
- Remote, full-time position
- Opportunity to work in an innovative, collaborative CRO environment
- Exposure to global projects across multiple continents
- Career growth in pharmaceutical regulatory writing
- Work on complex, high-level nonclinical documentation
