Job Summary

This is an operational position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, budget control and departmental collaborations. Work is escalated if outside of scope of role, and/or complexity? This position has strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time. Has sufficient knowledge to Identify critical issues or problems with Projects and/or identification of issues which may compromise patient dosing or safety. Basic understanding of professional working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized and the need for CAPAs or reports on deviations is clearly understood. Basic knowledge of Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the need to address such issues or concerns. Experience with IRT systems and support in managing the forecasting and planning of drug supply needs Able to participate effectively on a cross functional and on Global teams.

Job Description

Responsibilities

Works, under supervision, with outsourcing to submit appropriate requirements on a project basis. Supports team in generating RFPs and in reviewing proposals and selecting vendors. This position also supports the management of the WO development and implementation. Supports packaging design and patient kit supply preparation, label generations and approvals and associated interactions with vendors. Supports regular vendor/sponsor discussions to identify risks and ongoing study support. Identifies critical issues which may compromise patient dosing or safety. Supports comparator sourcing requirements, RFP generation and working with outsourcing to submit appropriate requirements on a Project basis. Vendor Management – support interactions with Vendors on packaging design and patient kit supply preparation, label generations and approvals. Support regular vendor/sponsor discussions to identify risks and ongoing study support. Ensures on time site shipments for subject and patient dosing, and ensures that material is fully released prior to shipment to site Ensures compliance with all domestic and foreign regulatory requirements but may seek line management support when necessary. Basic knowledge of Import/export requirements to the extent that there is overall recognition of potential global issues as regards import license requirements, shipment delays and is able to communicate the issues and support resolution development. Support IRT design for control of drug dispensing and inventory management. Understand User specifications in support of IRT processes and basic concepts of IRT

Responsibilities Continued

Qualifications

Education Qualifications
Bachelor's Degree in Pharmacy or related field preferred PharmD preferred Master's Degree preferred

Experience Qualifications
4 or More Years related experience preferred
Experience in Project Management, Clinical Supply Management, and/or Clinical Trials Coordination required
Demonstrated experience in working on inventory management, forecasting, and distribution of drug supply needs, IXRS experience, managing vendors and contributing to budget control preferred

Additional Information