Overview
Nonclinical QC Data Reviewer Jobs in Lexington, Massachusetts, USA at Integrated Resources, Inc ( IRI )
Direct message the job poster from Integrated Resources, Inc ( IRI )
Lead Recruiter at Integrated Resources, Inc ( IRI )
Title:
Nonclinical Quality Control Reviewer II
Job Duration: 9 months +
TOP 3 MUST HAVES:
Experience with QC of nonclinical study documentation
Familiarity with bioanalysis, pharmacokinetics, and pharmacology test systems and software
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:
3+ years’ experience in pharmaceutical/biotechnology environment
Prior experience with quality control of data for scientific reports and regulatory submission content
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), Graph Pad Prism, and understanding of lab-based analytical software.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Other
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Title: Nonclinical QC Data Reviewer
Company: Integrated Resources, Inc ( IRI )
Location: Lexington, Massachusetts, USA
Category: Healthcare (Medical Science, Data Scientist), Quality Assurance – QA/QC
