Scientist, Data Review

Job Description

About the Role:
We are seeking a highly meticulous and scientifically driven Data Review Scientist to join our Quality or R&D team. In this role, you will be responsible for reviewing scientific data—primarily from laboratory, clinical, or preclinical sources—for accuracy, consistency, and compliance with regulatory guidelines. This is a critical role that ensures scientific integrity and supports regulatory submissions, product development, or ongoing research programs.

Key Responsibilities:

• Review raw data, reports, and study documentation for scientific accuracy, completeness, and adherence to SOPs, GxP, or regulatory standards
• Identify discrepancies, data integrity issues, or protocol deviations and collaborate with cross-functional teams to resolve them
• Ensure proper documentation, audit readiness, and alignment with global regulatory requirements (e.g., FDA, EMA, ICH)
• Support preparation and review of study reports, data tables, and statistical summaries
• Participate in quality audits, inspections, or internal reviews as needed
• Communicate with scientists, statisticians, regulatory affairs, and clinical teams to verify data consistency across submissions
• Maintain tracking logs, review records, and version control for reviewed data

Required Qualifications:

• Master’s or PhD in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology, Biotechnology, Biostatistics)
• 2–6 years of experience in data review or quality roles within life sciences, clinical trials, or R&D
• Strong attention to detail and understanding of lab or clinical documentation standards
• Working knowledge of regulatory guidelines (GLP, GCP, GMP, ICH, 21 CFR Part 11)
• Proficiency in MS Excel and Word; familiarity with LIMS, ELN, or statistical software is a plus
• Excellent written and verbal communication skills

Preferred Qualifications:

• Experience reviewing clinical or bioanalytical study data
• Familiarity with eCTD submission formats or regulatory publishing tools
• Background in pharmaceutical formulation, drug development, or analytical testing
• Experience in handling deviation reports, CAPA, or change control documentation

What We Offer:

• Competitive salary and performance incentives
• Comprehensive medical, dental, and life insurance
• Career development opportunities in regulatory science and data integrity
• Collaborative, purpose-driven team culture
• Access to ongoing training and certification support

How to Apply:
📩 Submit your resume and a brief cover letter to: careers@[yourcompany].com
Subject: Scientist – Data Review Application – [Your Name]
🗓️ Applications reviewed on a rolling basis