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.
MUST HAVE:
Minimum bachelors 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
Excellent communication and interpersonal skills
Proficiency with MS office (word, excel), GraphPad Prism, and understanding of lab-based analytical software.