Description
Responsibilities:We are looking for someone for a 3 month contract supporting our Clinical Supply Chain Manager. This person would handle the day-to-day distribution of clinical supplies for our trials. They would be the point person for early trial distributions. Handle the mundane activities. Execute clinical supply plans. Working with phase 1 trials.
The group has the strategy in place for clinical supplies; we need someone to jump in and execute the plan.
Clinical Supply Chain Specialist / Senior Clinical Supply Chain Specialist
Position Level - Specialist / Sr. Specialist - will be determined based on the incumbent's qualification and years of experience.
Qualifications:
1) Coordinate the execution of orders, shipments, deliveries and payments of GMP and non-GMP cold-chain products between contract manufacturing organizations (CMOs) and warehouses, depots, clinics and other delivery points in the supply chain.
2) Work with transportation / freight forwarding companies to ensure swift and compliant passage of international shipments through customs, including the management of all necessary documents, certificates, approvals and other required information.
3) Track the inventories of cold-chain products at CMOs, clinics, warehouses and other key locations across the supply chain. Ensure that inventories are being managed in a compliant manner, and when they are not, collect key data to support the investigations process.
4) Support the clinical supply chain organization by performing ad-hoc activities including, but not limited to: data collection & analysis, document management, execution of ad-hoc supply activities and continuous process improvement.
- Monitor daily clinical shipments to ensure timely deliveries and expeditiously resolve any shipping related issues. Track and coordinate payments, labels and key logistics documents between CMOs, depots, vendors, customers, logistics providers, and 3PLs.
- Work with local regulatory agencies (heath authorities, customs, etc…) to ensure swift and compliant movement of goods through the approval process while ensuring all activities are performed according to regulatory requirements.
- Follow and maintain internal clinical supply chain SOPs in compliance with regulatory guidelines.
- Track inventories of products at CMOs, vendors, customers, logistics providers, 3PLs and other components of the supply chain on a regular basis. Project / estimate inventories in parts of the supply chain where visibility is limited, based on the best available information.
- Act as a first line resource to support the resolution of intra-departmental issues pertaining to transportation and logistics issues.
- Coordination with members of GTO, Regulatory, Clinical, and QA to ensure clinical supply chain metrics are met.
- Maintain current knowledge of US and international regulations in regard to the storage, transportation, import and export of pharmaceutical products.
- Other duties as assigned.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Education - Bachelor of Science in a technical field is preferred. Work experience may be substituted for education.
- Relevant experience of the logistics activities of commercial biopharmaceutical products across multiple phases of the product life-cycle (development, launch, maturity, pruning). Experience working an international distribution network is preferred.
- Knowledge of transportation regulations (USDoT) as well as all import / export requirements (Customs, FDA, USDA) with special emphasis on US and EU regulations.
- Knowledge of the GMP pharmaceutical launch process is highly desired.
- Must understanding of the Regulatory and GMP/GCP requirements associated with the some or all of the following areas is desired: pharmaceutical launch process, provision of clinical trial materials, interdependencies of the supply chain process, and/or clinical trial study design.
- Must possess the ability and desire for problem solving and decision making in a cross-functional team setting.
- High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines. Solid interpersonal and communications skills and the ability to deal effectively with a variety of personnel both internally and outside the company.
- Flexible, high level of integrity, action and goal-oriented. Balances process and theory with practical application and good judgment. Enjoys a fast-paced, team-oriented, and collaborative environment.
To find out more about Real please visit www.realstaffing.com