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Genmab

South Grafton, MA

Prior experience leading health authority meetings with the EMA or other health authorities
Strong project management skills
A good understanding of drug development and EU regulatory procedures
Experience in proactively planning and executing highly complex clinical submission strategies
Bachelor's degree or equivalent in scientific discipline or health-related field
Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications

Amherst College

Amherst, MA

Genmab

South Grafton, MA

8+ years of hands-on SAP experience, with at least 2 full-cycle SAP S/4HANA implementations focused on OTC and SCM
Demonstrated experience in life sciences or similarly regulated industries with SDLC and compliance frameworks
Strong experience in Demand and Supply Network Planning across global supply chains
Working knowledge of Transportation Management and its integration with sales and distribution workflows
Understanding of Logistics and Inventory Management
Proficient in Sales and Distribution (SAP SD) processes including order entry, pricing, delivery, returns, and invoicing
Bachelor's degree in Information Systems, Supply Chain Management, Logistics, or a related discipline
Deep expertise in end-to-end Order-to-Cash processes including Order Management, Billing, Credit Management, and their integration with logistics and financial operations
Hands-on expertise in Subcontracting processes involving Contract Manufacturing Organizations (CMOs)