Job
Description
Associate Project Manager - Supply Outsourcing Coordinator (SOC) is accountable to develop and maintain sustainable operational process and relationship with the Contract manufacturing organization (CMO) in outsourced medical supply chain activities. SOC scope includes External Sponsor Research (ESR) study requiring commercial product supply, Managed Access Program (MAP) product supply for structured program and single patient request (when outsourced), Individual Post Trial Access to Investigational Product (PTA2IP) product supply management (when outsourced), Humanitarian program and associated distribution activities This includes but is not limited to the following: Set up and lead outsourced supply management, from supply forecast to supply delivery to sponsor location/investigational sites, including packaging and labelling if applicable, with Medical Operations, Industrial Affairs/Distribution functional teams, Clinical Supply Chain Operations and CMC (depending on related medical activities) Get oversight of outsourced supply management for medical operations (eg Tracking of the vendors KPI, Periodical review of invoices Ensure outsourced supply activities is appropriately build in Sanofi and CMO tools as to maintain full tracking/chain of custody allowing proper and efficient supply/resupply of product to Health Care Professional. Manage Contract manufacturing organization Identify and manage deviations and risks associated with management of products Quarterly business review of the vendor in collaboration with procurement and quality People : (1) Report primarily to Supplier Operations Lead, Sanofi Business Operations (2) Key contact for Contract manufacturing organization and coordinate with all internal stakeholders; (3) Represent on supply/manufacturing discussions and communicate as appropriate with all internal groups regarding adequate supply and issue resolution; (4) Serve as primary contact for ad hoc requests from various Business Unit functions and Local/Regional teams for supply forecast data and shipment information Performance : (1) Ensure deliverables meet the required timelines, quality targets and adhere to the compliance requirements; (2) contribute to continuous improvement initiatives, in collaboration with the Operations & Efficiency Lead for Global Access Programs, and Medical Operations; (3) Manage risk and implement back-up plans when needed; (4) Investigate the root cause when issues arise and recommend the remediation plan Process : (1) Perform supply planning & order management activities including cross-checking orders against forecast and management of order backlog; (2) Support the team with CMO (Request For Proposal) and Technical Conditions completion; (3) Owner of program / study demand forecast in Kinaxis; includes data entry, alignment with open orders and financial plan and communication with local/regional teams to understand demand drivers, identify gaps and ensure resolution, etc; (4) Identify, communicate, and escalate root causes of any variations to the program / study forecast; (5)Represent Medical Functions at decision making committee for supply matter(eg Study review Committee, Franchise Global Medical Team) specific therapeutic area monthly Global Demand Review; (6) Support Global Medical Operations with financial planning activities including development of financial plan (3x per year), quarterly landing exercise and detailed year end shipment tracking; (7) Monthly shipment reconciliation; includes detailed review of shipments, identification, and resolution of discrepancies; (8) Reconcile discrepancies between demand and financial forecast; (9) Work closely with Global Supply Planning team to ensure that for any product request the supply is secured; (10) Contractual requirements are met including minimum shelf life, packaging updates, etc; (11) Manage supply planning & delivery commitments for quantities & timeliness in accordance with the supply license agreements; (12) Partner with Global Medical Operations to manage order backlogs; includes liaising with customer service, problem solving and interaction with local markets; (13) Track inventory and replenishment planning for MAP; (14) Provide periodic static data extraction and validation for integrity and consistency; ensures data updated in relevant supply chain systems; (15) Evaluate the service level provided by the vendor. Report data on CMOs KPIs and metrics, update and distribute dashboards Stakeholders : (1) The Supply Outsourcing Coordinator will interact internally and externally with GBU Medical Operation teams in charge of ESR, MAP, Humanitarian, R&D - Development team in charge of IPTA2IP, CMO team, Global Regulatory Manager, Global IA and Distribution Quality Manager, iCMC Demand Supply Leaders, Clinical Supply Chain Operations Project Operational Leader (during transition phase), Global Finance, Global Legal & Supply Procurement; (2) And other functions as per supply outsourced activities needs, validation in invoice, Coordination of RFP distribution, Coordination and validation of technical conditions, and other relevant stakeholders regarding medical devices Experience: 5+ years of experience in supply chain activities such as demand & supply planning, third party operations, including at least 3 years in the biopharmaceutical industry Soft skills: Strong administrative and organizational skills Technical skills : Basic MS Office skills, Smartsheet Education : Bachelor/Higher Degree Languages : Excellent knowledge of English language (spoken and written)
