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Lead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
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....
Lead pharmaceutical development projects for drug entities (mAB/protein) at all levels of complexity and new modalities (e.g. ADC, mRNA). Projects will involve QC, different...
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...
Developing and maintaining an expert understanding of the safety profile of the assigned products as well as understanding of the relevant strategic context (e.g disease under...
This role will be pivotal in integrating quantitative methods to advance the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug...
Are you an experienced Regulatory Affairs leader with a passion for medical devices? Are you looking for a motivated and diverse department to empower, guide and mentor Applied...
The position leads the Global Development Team for the Asset and works in partnership with other global asset functions in accordance with Target Product Profiles (TPP) as jointly...
Accountable for external PV vendor development and oversight, including quality, performance and compliance of cases, support budget review and strategies of tasks outsourced to...