Research Associate Jobs

About The Position

Requirements

• Bachelor's degree in Life Sciences.
• 3 to 4+ years of experience in a relevant field.
• In-depth knowledge of Good Laboratory Practices, FDA regulations, ICH guidelines, and the drug development process.
• A successful track record of managing multiple projects in a fast-paced, deadline-driven environment.
• Impeccable attention to detail and excellent written communication skills.
• Proficiency in Microsoft Suite, including Word, Excel, PowerPoint, and Visio.

Nice To Haves

• Professional certification or credentials.
• Experience with regulatory submissions.
• Experience with Veeva.
• Experience with other electronic document management or tracking systems.

Responsibilities

• Perform quality control review of nonclinical content for DMPK and Toxicology reports and regulatory submission documents, including Module 2 and Module 4.
• Edit and format documents in Word and prepare PDFs for regulatory submission in accordance with style guides and regulatory guidelines.
• Provide Veeva support for nonclinical regulatory document lifecycle management activities.
• Support literature reference activities, including retrieval, copyright clearance review, and uploading references to an electronic document management system.
• Solve problems independently, exercising sound judgment, appropriate interfacing, and flexibility in a dynamic environment.

Benefits

• Comprehensive medical coverage
• Dental coverage
• Vision coverage
• Life insurance
• Disability insurance
• 401(k) with company match
• Paid vacation
• Paid holidays
• Yearly goal-based bonus
• Eligibility for merit-based increases