Data Manager, ACDS Informatics

Role: Data Manager specializing in pharmaceutical analytical data and reporting to support regulatory submissions and scientific decision-making across drug development stages. Responsibilities: deliver compliant, submission-ready data; design automated workflows; develop dashboards using tools like Spotfire and Power BI; collaborate with scientists, regulatory, and digital teams to translate needs into scalable digital solutions; promote data standards, integrity, and process modernization; support laboratory informatics platform enhancements and governance. Qualifications: Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, Data Science, or related field; 10+ years (or master's with 6+ years, Ph.D. with 3+ years) in pharmaceutical data management, informatics, analytics, or regulatory support; experience with GxP, data integrity, laboratory informatics, and visualization tools (e.g., SQL, SAS). Preferred: knowledge of CMC regulatory submissions, cloud analytics, generative AI, and digital transformation leadership. High-value specifics: supporting analytical data for regulatory filings, working across QA, R&D, and regulatory functions; focus on laboratory informatics, automation, and data democratization; 10% travel; hybrid work environment.