Preclinical Research Associate

EurofinsBoston, MA, United StatesremoteSalary not postedView the original posting at Eurofins ↗

Performs quality control (QC) review of nonclinical content for various DMPK and Toxicology reports as well as Module 2, Module 4 of regulatory submission documents. Provides editing, word formatting, and PDF submission-readiness support for nonclinical regulatory submission documents in alignment with style guides and regulatory guidelines. Provides Veeva support for various nonclinical regulatory document lifecycle management activities. Supports literature reference-related activities, including (but not limited to), retrieval, copyright clearance review, upload to electronic document management system, etc. Independently solve problems, exercising sound judgment, appropriate interfacing, and flexibility within a dynamic environment. Bachelor's degree in Life Sciences with 3 to 4+ years’ experience in relevant field. Professional certification/credentials, experience with regulatory submissions is a plus. In-depth knowledge of Good Laboratory Practices, FDA regulations, ICH guidelines, and the drug development process. Successful track record of managing multiple projects in a fast-paced and deadline-driven environment. Impeccable attention to detail and excellent written communication skills. Must be proficient in Microsoft® Suite (Word, Excel, PowerPoint, Visio). Experience with Veeva is preferred. Experience with other electronic document management and/or tracking systems is a plus.

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