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Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle. Collaborate with cross...
Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product...
You will conduct activities necessary for the determination of the safety profile and the characterization, monitoring, and mitigation of risk for the assigned products throughout...
Lead and manage a team responsible for all aspects of CMC regulatory strategy, planning, and execution across the product lifecycle, including both development and commercial...
Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient...
Develop and execute EU medical launch readiness plan for assigned products in neurology/psychiatry area. Support to clinical development with input on target product profile, based...
Engaging in high-quality peer-to-peer scientific dialog with key European Thought Leaders (TLs) in Neurology focused on pre- and peri-launch period. Collaborates with European...
Act as the quality lead for all Externally Sponsor Research, Non-interventional studies, Early Access Programs, Name Patient Programs and other non traditional clinical studies....
Provides medical oversight of assigned clinical studies in the duty as a medical monitor. Often serves as primary medical contact for customers for assigned clinical studies;...
Proactively identify possibilities to optimize case management, case management vendor oversight and process improvements within SOBI. Support the Global PV Case Management Lead in...