Preclinical Research Associate

Job Description

• 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.

Qualifications

• 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.

Additional Information

This is a full-time position, Monday-Friday 8:00am-5:00pm, based in Boston, MA.

What we offer

• Comp: $90-100k

• Excellent full-time benefits, including 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

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.