The Quality Systems Manager supports GxP compliance, enhances Quality Systems, trains staff, conducts audits, and ensures regulatory adherence across programs.

Lead analytical development activities for drug products and substances, ensuring compliance with GMP standards and overseeing external providers. Collaborate with CMC teams to optimize processes and deliver product quality.

The TMF Operations Lead ensures accurate clinical trial documentation, oversees eTMF systems, monitors TMF health, and guides trial teams in compliance and resolution of TMF issues.

Collaborate with teams to design, maintain, and deploy software systems that ensure compliance and operational excellence in a clinical environment.

The Director of Commercial Compliance will develop and lead the compliance program for product launches, ensuring regulatory adherence and operational support across various departments while providing training and risk assessments.

The Associate Director, PV Scientist oversees pharmacovigilance data, ensuring regulatory compliance, enhancing safety infrastructure, conducting signal detection, and managing safety narratives and reports.

The Senior Accountant will support monthly close, prepare financial reports, and assist with FP&A functions related to budgeting and forecasting.

The Director of Commercial FP&A leads financial planning and analysis for a commercial organization, focusing on launch readiness, revenue forecasting, and strategic finance partnerships with cross-functional teams.

Lead development of analytical pipelines and statistical models using R and Python for clinical data processing and reporting. Mentor peers and ensure compliance with regulatory standards.

The Senior Director leads global pharmacovigilance operations, ensuring compliance, managing safety reporting, and collaborating across functions while overseeing vendor relationships and enhancing capabilities.

Lead oversight of data management for assigned studies, manage external vendors, review and approve DM documentation, perform secondary UAT of EDC, implement RBQM oversight, and provide cross-functional input on protocols and study deliverables to ensure data quality and regulatory compliance.

The Senior Director of Quality Excellence leads and oversees Praxis's Quality Management System, ensuring compliance with global regulations and continuous improvement across all systems and processes.

Manage analytical development projects, ensure compliance with GMP standards, oversee external partners, and support CMC stability programs in drug development.