Preclinical Research Associate

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.

Key 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.

Qualifications :

• Bachelors degree in Life Sciences with 34 years of relevant experience; regulatory submissions experience and/or professional certifications are a plus.
• 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.
• Experience with Veeva preferred; familiarity with other electronic document management or tracking systems is a plus
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Additional Information :

The position is Full Time Monday through Friday 8am-5pm. Candidates currently living within a commutable distance of Boston MA are encouraged to apply

What to Expect in the Hiring Process:

• 10-15 Minute Phone Interview with Regional Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader

What We Offer:

• 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
• Compensation is between $90000 - $100000 annually depending on education and experience 

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

Remote Work :

No

Employment Type :

Full-time