Lead eTMF oversight and vendor management across studies, ensure GCP/SOP compliance, administer eTMF system, track TMF metrics, provide training and guidance, support inspections/audits, drive process improvements, and manage junior staff.

Support eTMF set-up, maintenance, and vendor oversight; manage Veeva Vault licenses and site master lists; assist with SOP/WI reviews, training, inspections preparation, audits, and process improvements across Clinical Operations.

Provide administrative support to Clinical Operations to facilitate clinical trial planning and execution. Maintain study trackers and reports, route and track essential documents and agreements, support eTMF/Veeva study setup and filing, coordinate trainings and meetings, assist regulatory and vendor communications, and perform ad hoc study-related tasks.

Lead global product teams to define strategy, launch and lifecycle management for late-stage and commercial pharmaceutical products. Coordinate cross-functional planning, timelines, budgets, risk mitigation, stakeholder alignment, and tracking to ensure commercialization success. Drive issue resolution, communication, and high-performing teams.

Develop and QC SDTM and ADaM datasets, perform independent QC of endpoints, deliver ad-hoc analyses, collaborate with data management and statisticians, and help develop departmental standards and training.

Lead day-to-day QC laboratory operations, manage and develop QC staff, ensure timely high-quality analytical testing and regulatory compliance, drive investigations and corrective actions, support lab expansion/qualification, implement KPIs and continuous improvements to scale QC for clinical and commercial manufacturing.

Provide administrative support to Clinical Operations by maintaining trial master files, study trackers, vendor purchase orders, meeting logistics, eTMF filing/reconciliation, QC of study documents, supply management, and assisting with SOP/WI training and study agreements.

Author, edit, and standardize GMP manufacturing QMS documentation including deviations, investigations, CAPAs, and change controls. Ensure records are inspection-ready, data-integrity compliant, and traceable. Coordinate with SMEs and cross-functional teams to translate technical input into clear, evidence-linked narratives and support audits/inspections.

Provide biostatistical leadership for clinical trials including study design, randomization, sample size, and SAPs. Perform analyses in SAS/R, develop tables/figures for submissions, QC statistical outputs, collaborate with clinical, data management, and programming teams, and support methodological evaluation and process improvements.

Provide QA support for contract development, manufacturing, and testing organizations: review and approve vendor documentation, perform lot disposition and Certificates of Compliance, manage quality documentation and metrics, collaborate on non-conformances, draft and approve SOPs/WIs, and support cross-functional teams for preclinical and clinical programs.

The Summer Intern will support the Commercial and Market Access team by analyzing payer management strategies, impact on patient access, and contributing to quantitative models for therapy evaluations.

As a Senior Scientist I in Quality Control, you will conduct and support analytical testing for pharmaceutical materials and stability studies, lead technical discussions, and mentor co-workers, ensuring compliance with cGMP and ICH guidelines.

Contribute to Quality Management System by managing internal/external audits, ensuring compliance with GxP regulations, and driving continuous improvement efforts.

The Summer Intern will assist in early CNS research, support protein expression studies, and analyze experimental data while preparing presentations.

The Project Coordinator supports nonclinical drug development by assisting in toxicology documentation, studies, and collaboration with various teams for regulatory submissions.

Lead pharmacometrics and clinical pharmacology strategies for Arrowhead's global clinical development, ensuring scientific rigor and regulatory alignment in trial designs and submissions.

Provide quality assurance support for programs using contract development and manufacturing organizations by reviewing vendor documentation, performing lot disposition, and generating quality metrics.

The Specialist III in Quality Assurance supports development programs by reviewing manufacturing records, analytical data, and ensuring compliance with GMP regulations while collaborating with other departments.

The Records Management Intern will support organizing and digitizing records to enhance efficiency and compliance in a pharmaceutical setting.

The intern will analyze neurophysiology data, assist in molecular characterization, collaborate with scientists, and maintain experimental records.