Clinical Supplies Project Lead応募後で応募 求人ID R0025365 掲載日 11/25/2020 Location:Lexington, Massachusetts; Boston, Massachusetts
- Under the direction of the Clinical Supplies Team Lead, the Clinical Supplies Project Lead is responsible for Clinical Supply delivery in support of Takeda R&D Global Clinical Trials and other supportive research or development needs, and works with both internal and external customers and suppliers in order to develop and communicate project budgets and plans and to ensure that all project objectives are met in a timely and compliant manner.
- The Clinical Supplies Project Lead’s areas of responsibility include coordination and management of the procurement, packaging, labeling, distribution return, reconciliation, and destruction activities of Investigational Medicinal Products.
- Leads Global Clinical Supply Chain group initiatives including the active participation of the study oversight process for Global Clinical Supply Chain activities for the Takeda Trial Delivery Operation Model (TDOM).
- Works with Clinical Supplies Planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines and budgets.
- Utilizes the Smart Supplies Clinical Supplies Management Database (PMD) for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities.
- Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality.
- Interfaces with Clinical Supplies Technologies Team to understand IRT standards and PMD requirements and proactively designs database methodology and/or trouble-shoots potential challenges.
- Interfaces with appropriate QA/QP personnel to help plan work activities and to facilitate expeditious release of IMP for shipment to sites.
- Interfaces with Pharmaceutical Sciences group to ensure that trial supplies are appropriately supported and that appropriate stability programs are in-progress, and/or appropriate expiry dating exists.
- Works closely with Import/Export Logistics function to pro-actively plan, document, and facilitate global cross-border supply strategies, including requirements associated with controlled substances, compliance to global trade standards, and in-country investigational product regulatory requirements for delivery of product to final destinations.
- Works with Clinical Supply Specialists to manage and troubleshoot shipment requests, drug returns, PMD, and IRT processes. Works with them to ensure creation and maintenance of Clinical Supply IMP documentation and product specification files (where required) according to established procedures and to manage IMP inventory for projects assigned.
- Coordinates primary and secondary packaging, labeling, testing, distribution, return drug management activities with contract providers according to approved budget. Ensures that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements. Processes compliant invoices promptly to ensure optimal value to Takeda.
- Excellent communication, organizational, and team collaboration skills.
- Must work effectively with global work associates.
- Ability to interact effectively at high levels, between customers and suppliers, and to manage and resolve issues and to provide effective feedback.
- Must be able to handle multiple projects simultaneously while maintaining high quality results.
- Must provide and implement innovative solutions to unique situations.
- Must be able to recognize potential conflict and escalate when necessary.
- Must be aware and compliant to regulations and requirements for functioning under GMP, GDP, and GCP’s and Annex 13 and EU CT Directive, and DEA or local controlled-substance regulations as required.
- Degree in Pharmacy, other scientific/technical degree, or significant job related experience.
- 5-8 years relevant Pharmaceutical Industry and/or Contract Provider experience is preferred.
- Experience with Medical Devices a plus.
- Strong understanding of cGMP requirements
- Proficiency in computer software applicable to IRT, Excel and MS Project or equivalent project management software is a plus