Preclinical Research Associate

Eurofins USA PSS Insourcing Solutions • Boston, MA

20h • Onsite

About The Position

This role will support quality control and submission readiness of nonclinical regulatory documents. The Nonclinical Regulatory Documentation Specialist will contribute to DMPK and Toxicology reporting, regulatory submission modules, and document lifecycle management in a fast-paced, compliance-driven environment.

Requirements

• Bachelor’s degree in Life Sciences with 3–4+ years of relevant experience
• Strong working knowledge of Good Laboratory Practices (GLP), FDA regulations, ICH guidelines, and the nonclinical drug development process.
• Proven ability to manage multiple projects and deadlines in a fast-paced environment.
• Exceptional attention to detail with strong written communication skills.
• Proficiency in Microsoft® Office tools, including Word, Excel, PowerPoint, and Visio.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Nice To Haves

• Regulatory submissions experience and/or professional certifications are a plus.
• Experience with Veeva preferred; familiarity with other electronic document management or tracking systems is a plus.

Responsibilities

• Perform quality control (QC) review of nonclinical content for DMPK and Toxicology reports, as well as regulatory submission documents including Module 2 and Module 4.
• Provide editorial support, including document editing, formatting, and preparation of submission-ready Word and PDF files in accordance with internal style guides and global regulatory requirements.
• Support Veeva activities related to nonclinical regulatory document lifecycle management, including document routing, version control, and archival.
• Assist with literature reference-related activities, including reference retrieval, copyright clearance review, and upload to electronic document management systems.
• Independently identify and resolve issues, exercising sound judgment, effective communication, and flexibility within a dynamic, cross-functional environment.

Benefits

• Comprehensive medical coverage
• Dental options
• Vision options
• Life insurance
• Disability insurance
• 401(k) with company match
• Paid vacation
• Paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level