Nonclinical Writer

Join us as a Nonclinical Writer at MMS, a leading data‑focused clinical research organization. This full‑time, remote position involves the development, writing, and management of highly technical nonclinical documents.

• Strong experience with development and writing of nonclinical documents such as Module 2.4 and 2.6 eCTD submissions, Investigator’s Brochure (IB), Nonclinical Study Reports, Meeting Requests, Briefing Documents, and RTQs.
• Lead projects independently with minimal oversight, writing the structure, content, and messaging of nonclinical documents, and ensuring alignment with regulatory guidelines and scientific integrity.
• Author based on highly technical sources (GLP and non‑GLP study reports, in‑vivo and in‑vitro data).
• Develop a mapping plan for placement of nonclinical studies within the structure of Module 2.4 and 2.6 eCTD 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, biostatistics, regulatory operations, and CMC.
• Lead others to complete complex projects.
• Complete documents according to sponsor format, processes, and regulatory guidelines.
• Operate effectively in an environment requiring negotiation, persuasion, collaboration, and analytical judgment.
• Organizational expert within the nonclinical subject area.
• Excellent written and oral communication with 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, Please Review, End Note).
• Strong understanding of regulatory guidances applicable to nonclinical submission documents and drug development (ICH, FDA, EMA, GLP, GCP, GMP, GDP).

• BS+ in pharmacology, toxicology, biology, chemistry, or related field, with industry experience in regulatory writing, regulatory affairs, laboratory sciences, or 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 terminology and the drug development process.