South San Francisco, CA30+ days ago
Collaborate with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials Collaborate with Clinical Operations and Regulatory Affairs to provide packaging and labeling information, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations Works closely with QA to ensure compliance with IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules, Tracking GCP adherence at sites Participates in the review of IP-related study documents (e.g., pharmacy manual, IP section of protocol) and training materials for clinical study teams and investigational site use as needed. Job Responsibilities:
As part of the Clinical Supplies Planning and Logistics team, participates in clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, label text generation and approval, packaging and labeling operations at clinical supply vendors, batch record review, distribution management, temperature excursion, expiry extension, drug return and destruction records, and inventory management.