Job Description

Non-Clinical Quality Control Reviewer II

On-site in Lexington, MA

Must be able to work on a W2

TOP 3 MUST HAVES:

1. Experience with QC of nonclinical study documentation

2. Familiarity with bioanalysis, pharmacokinetics, and pharmacology test systems and software

3. Detail oriented with strong analytical skill set

PURPOSE/JOB DESCRIPTION:

This position will work closely with nonclinical medical writing, toxicology, bioanalytical, pharmacology, and research teams to conduct QC activities to support delivery of accurate, compliant, and submission-ready documents, including study reports and regulatory summaries.

ESSENTIAL FUNCTIONS:

• Perform QC review of raw data generated by ADME team, including bioanalytical data generated by HPLC-FD and LC-MS/MS systems and qPCR
• Verify data for accuracy, completeness, and compliance with internal guidelines
• Work with team to resolve inconsistencies
• Work closely with nonclinical writing team to provide QC review of reports and nonclinical regulatory content; ensure final documents adhere to internal procedures as well as FDA/ICH guidelines
• Complete reviews per established timelines

QUALIFICATIONS:

• Minimum bachelor's degree in life science discipline
• 3+ years experience in pharmaceutical/biotechnology environment
• Prior experience with quality control of data for scientific reports and regulatory submission con-tent
• Familiarity with FDA guidance and ICH guidelines preferred
• Critical attention to detail and strong organizational skills
• High degree of fluency with written English
• Excellent communication and interpersonal skills
• Proficiency with MS Office (Word, Excel), GraphPad Prism, and understanding of lab-based analytical software.

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