Preclinical Research Associate

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Conduct quality control (QC) assessments of nonclinical content for DMPK and Toxicology reports.

• Evaluate Module 2 and Module 4 regulatory submission documents.

• Offer editing, document formatting, and ensure PDF submission readiness for nonclinical regulatory submission documents.

• Ensure alignment of documents with style guides and regulatory standards.

• Provide Veeva support for managing the lifecycle of nonclinical regulatory documents.

• Assist with literature reference activities, including retrieval, copyright clearance review, and uploading to the electronic document management system.

• Solve problems independently by exercising sound judgment, effective communication, and adaptability in a dynamic environment.

⛳️ Requirements

• Bachelor's degree in Life Sciences.

• 3 to 4+ years of experience in a relevant field.

• Professional certification or credentials are a plus.

• Experience with regulatory submissions is advantageous.

• Comprehensive knowledge of Good Laboratory Practices, FDA regulations, ICH guidelines, and the drug development process.

• Proven ability to manage multiple projects in a fast-paced, deadline-oriented environment.

• Exceptional attention to detail and outstanding written communication skills.

• Proficient in Microsoft® Suite (Word, Excel, PowerPoint, Visio).

• Experience with Veeva is preferred.

• Familiarity with other electronic document management and/or tracking systems is a bonus.

🏝️ Benefits

• Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options.

• Life and disability insurance.

• 401(k) plan with company match.

• Paid vacation and holidays.

• Yearly bonus based on performance goals.

• Eligibility for merit-based salary increases.

• Monday to Friday schedule from 8:00 am to 5:00 pm.