Key accountabilities

Main mission: 

• The mission of the CMC Material & Documentation Flow Platform is to support the efficient coordination of Drug Product (DP) and Marketed Products (MP) transfer and receipt to sustain clinical and non-clinical development. 

• Projects & scope: All products under the responsibility of the CMC Integrated Demand & Supply team 

Key accountability: 

• Supports CMC Integrated Demand and Supply team in the management of material and documentation requirements for shipment and receipt of products (drug products or marketed products) under the accountability and supervision of / and the timelines defined by Demand & Supply Leader assigned to a given project. 

• This includes:  

• Providing Material Flow Management (MFM) services : 

• Create and maintain material codes in ERP systems 

• Execute ERP transactions (Purchase Orders and Transfers Orders) 

• Coordinate Drug product transfer from manufacturing facilities to packaging facilities  

• Oversee Drug Product (DP) flow management for Contract Manufacturing Organization (CMO) Packaging 

• Coordinating and execute Drug Product destruction plans 

• Serving as Subject Matter Expert (SME) for Qualipso and Provide technical support for Qualipso events management (including CMO/FSO) (e.g., temperature excursion management, deviation handling) 

• Filling product documents such as (but not limited to): Product Information Document (PID), Drug Product Study Document (DPSD), Traceability reports, Technical Conditions for DP shipments, 

• Filling products data in D&S tools such as (but not limited to) COMPASS, Demand Module (DMM), RDPM, 

• Request of product documents to the appropriate owners as prerequisites for DP handling such as (but not limited to) TOR, quarantine and shipment authorization, CoR/CoA, US customs documentation, preparation and tracking of French Import License request form, 

• Provide customs documentation expertise and support in documentation management in compliance with regulatory requirements : 

• US customs documentation 

• CN customs requirements definition 

• French Import License request form preparation and tracking 

• Support operational planning activities by providing DP schedule information to CSC Operations warehouse 

Education / Experience

• Bachelor of Science (BS) degree with at least 2-3 years’ experience in supply chain, CMC, clinical fields, pharma R&D,  

• GMP certification is a plus 

Technical skills & Competencies / Languages

• Strong knowledge of Pharma Product Manufacturing/Packaging 

• Strong knowledge of CMC and Clinical Supply Chain processes and deliverables   

• Strong knowledge of ERP systems 

• Project Management skills 

• Digital skills  

• Excellent oral and written communication skills  

• Proficiency in written and spoken English is required to interact with multiple interfaces worldwide, 

• Ability to work productively with a broad and diverse group of stakeholders,  

• Ability to prioritize tasks 

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

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Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.