Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC).
Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines.
Create supply and inventory plans and develop production schedules for clinical trial materials.
Monitor schedule adherence of production schedules and make course corrections if needed.
Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability.
Manage the relationship and oversee daily activities for FG label & pack CMOs and distribution vendors.
Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure.
Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).
Coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs.
Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system.
Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses.
Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans Lead cross functional projects and process improvements related to drug supply.
Assist in the creation of Standard Operating Procedures.
Requirements
Experienced in global clinical trials and the drug development process.
Experience in vendor oversight and managing external partnerships and relations.
Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP).
Experience in deviation investigation and CAPA implementation.
Knowledge of IRT system setup and functionality and proficiency with Excel modeling.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
Staffing and Recruiting
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