Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Comply with all applicable legislations/regulations and support worldwide transportation & distribution while meeting the needs of BMS clinical trials of Investigational Medicinal Products (IMPs), Expanded Access Programs (EAP) and/or Investigator Sponsored Research (ISR) and collaboration partners.
Major Duties for our Shipment Order Execution:
Act as liaison between the internal and external stakeholders (Drug Supply Management, Clinical, Medical, Regulatory, Quality, external suppliers, etc.) and serve as central point of contact for investigational medicinal product shipments.
• Create, organize, and coordinate IMP shipments to sites, ensuring regulatory requirements are complete as required prior to IMP shipment delivery to customers and ensuring accurate and timely delivery to warehouse and investigator sites as outlined in the Drug Provisioning Plan and as initiated via individual site order request (manual or IRT - Interactive Response Technology). This includes:
o Working with a range of internal and external stakeholders to troubleshoot and resolve problems, ensuring uninterrupted supply of medicines to patients and support of trial deliverables. This includes issues such as troubleshooting and coordinating resolution of IRT to SAP order failures with urgency to ensure drug availability at the site in time for patient treatment or resolving and addressing drug delivery issues ensuring accurate and timely delivery to final delivery address (BMS sites, investigator sites, 3rd party warehouses).
o Guaranteeing logistical requirements i.e. Green Light, provision of required documentation (certificates, import permits, etc.) and accurate pro-forma invoices, etc. are met.
o Ensuring timely SAP Goods Issue, pro-active delivery tracking, entry of SAP POD (proof of delivery) for non-IRT studies, SAP Goods Receipt entry, and adequate follow up until unblocking of supplies, timely communication with internal stakeholders, third party vendors, and investigator sites.
o Support customs brokerage, customs clearance and associated activities including active contribution to the implementation and compliance with customs procedures in relation to distribution activities.
o Collaborate with TPA (Temperature Profile Administrator) to obtain assessment for temperature excursions and provide usage decisions to sites or warehouses in a timely manner.
o Promptly communicate critical drug availability issues to the Shipment Execution Team Leads and Drug Supply Management teams.
o Contribute to the maintenance of GMP/GDP compliance and audit-readiness state, including active contribution to management of incident reporting and investigation, including initiating, following up, and closing NTR’s (Notation to Record), Quality Events, Investigations and CAPA’s (Corrective and Preventative Action) in Trackwise within company timelines for transporters and distribution sites.
o Ensure appropriate coordination and proper execution of redeployment shipments (export & import), field transfers, as well as special returns for quality investigation events in collaboration with the representative Clinical teams, Drug Supply Management teams, IRT vendors, Quality teams, and transportation providers.
o Manage appropriate delivery deletion and update of related systems (IRT, SAP) accordingly.
o Consult subject matter experts for anything related to customs, brokerage, payments of vendor invoices, import/export processes.
Supplier relationship management and logistics analysis
• Supplier relationship management and oversight of third party vendors across a range of distribution activities supporting the supply and transportation of investigational and expanded access medicines to sites worldwide, including warehousing providers, transportation providers, and packaging suppliers for the Americas region.
• Monitor the stock of empty credo boxes and organize international returns.
• Consult applicable transport & packaging guidelines or get advice from related Subject Matter Experts (SMEs) i.e. transportation/TPA to guarantee optimal protection of sensitive IMPs during transit.
• Collect relevant metrics and conduct analysis to support budget management, vendor performance management and continuous improvement goals.
• Support and contribute to local compliance with aviation transport security arrangements including control processes, training and validation inspections.
• Contribute to continuous improvement across a range of distribution support activities such as optimization of global freight and integrator processes, warehouse network, order management, customer support and distribution capabilities in compliance with national and international regulations and in collaboration with internal / external cross functional stakeholders.
Other responsibilities will be requirements as assigned or as the business evolves, responsibilities may adjust accordingly.
• Bachelor Degree in relevant field (science, engineering, supply chain, logistics, business administration) with significant experience of operational GDP distribution activities.
• Experience in international logistics management and/or supply chain expertise with understanding of key import/export matters, GMP / GDP concepts, preferably as related to investigational product distribution activities.
• Awareness of or experience with clinical supply processes related to investigational medicinal product shipments such as project management, documentation generation, general study information tracking and IRT/IVRS would be an asset.
• Experience working with third-party service providers, outsourcing & distribution planning.
• Excellent communication skills, including fluency in verbal and written English. Bilingual would be an asset.
• Strong interpersonal communication skills and ability to build strong relationships and networks. Demonstrates a persistent, pro-active, flexible, and team oriented work ethic.
• Customer minded, stress resilient, and quality/detail oriented
• Strong organizational skills. Demonstrated ability to manage multiple projects simultaneously and to complete complex projects independently
• Strong project management and analytical skills, preferably with an operational knowledge of SAP and proficient in Microsoft Office skills, data handling and analysis
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.