Clinical Supply/Outsourcing Manager

Welcome to Novartis - the company that considers its employees to be its greatest asset. Good Business. Great Opportunities. How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think What's Possible.General TasksPlans, establishes, manages and monitors contracted activities to assure error-free and in-time packaging of drug supplies for clinical studies (Phase I-IV), and timely shipment of materials according to GMP, GCP, GDP and other regulations. These activities are performed in cooperation with Novartis QA and other line functions, and with Novartis approved contractors and vendors.ResponsibilitiesPrimary liaison with contractors for outsourced packaging and distribution campaignsProvides input and identifies activities to be outsourced at DSM Capacity MeetingsAssists Head of Outsourcing in resource planning and participates in overall planning of DSM activitiesWorks with DSM Study Manager to advise on and challenge protocol aspects related to packaging design and supply for studies which are to be outsourcedInitiates and participates in audits together with GMP QA and GCP QA (where applicable) to assess contractors capabilitiesDrafts RFP (Request for Proposal) to solicit bids from approved contractors and vendors for desired servicesSelects and awards contract based on review of all proposals (with input from other DSM functions). Decision based on pricing, technical abilities, capacity, etc.Provides estimation of outsourcing costs to the Head of Study Team for budgeting purposesInitiates Purchasing Grant After approval of grant, obtains PO (Purchase Order) Writes Work Order for specific outsourcing activitiesOrganizes and coordinates the shipment of drug product and packaging material and the transfer of necessary documentation to the contractorWorks with Novartis QA on the review and approval of contractor Master Packaging Record (MPR) and packaging instructionsEnsures that contracted activities meet the approved packaging design for the study protocolMonitors in-process/on-going work at contractorsProvides troubleshooting expertise and resolves issues to keep activities on scheduleEstablishes the study supply chain of contracted activities together with DSM Study teamsEstablishes and manages supply related timelines with other groups, i.e.; QA, ARD, etc Contributes to the definition of specifications for IVRS studiesReviews completed contractor packaging records and forwards to Novartis QA for final approval (Technical Green Light) Organizes and coordinates the distribution of packed medication from the contractorAssists in the monitoring and tracking of batches and medication together with Drug Supply Planner and Study ManagerResponsible for materials and inventory management of all drug product, components and labels at the contractorsAuthorizes destruction of outdated material Approves for payment, contractor invoices for all completed workQualificationsDegree in Pharmacy, Natural Science or related experience in drug developmentProfessional Requirements:Good organizational and planning skillsGood communication and negotiation skillsQuality orientedTeam orientedAbility to perform detailed tasksGood command of EnglishNecessary Job experience:3 years experience in Clinical Supply Operations, Pharmaceutical Development, Clinical Development, Project Management, Planning or related fieldBasic understanding of the complete drug development and clinical development processBasic knowledge of GMP, GCP and regulatory requirementsBasic knowledge of clinical protocol designGood knowledge of clinical packaging proceduresGood knowledge of technical specifications related to clinical packagingBasic knowledge of distribution and shipping procedures related to clinical suppliesGood knowledge of materials and inventory management as well as distribution procedures related to clinical suppliesGeneral knowledge of business related areas: project management, contracts, invoicing, and financeWorking knowledge of relevant IT systems Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.To apply for this position, Click HereTo learn about other Novartis opportunities, Click Here Link to Novartis Pharmaceuticals opportunities Send this Job to a Friend EEO Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.