Preclinical Research Associate
Eurofins•Boston, MA
•$90,000 - $100,000•Onsite
About The Position
We are seeking a detail-oriented and highly organized Nonclinical Regulatory Documentation Specialist to support quality control and submission readiness of nonclinical regulatory documents. This role 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, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Yearly goal-based bonus & eligibility for merit-based increases
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
