About this role
- 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.
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.