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Provide strategic regulatory and scientific support on pre-clinical and clinical development plans and work with both Regulatory Affairs - New Products and Regulatory Affairs...
In this position you will be a member of the BPS Operations leadership team and will interact closely with the Head of quality LPS as well as the Quality management ATS to ensure...
Serves as a senior scientific and clinical expert for safety profile of products in therapeutic areas; Defines global product safety strategy and routinely manages and leads...
You will be responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related...
Core activities will include conducting HTA (NICE in particular) compliant SLRs, developing and running literature database searches, data evaluation and extraction, report...
Manage the clinical development of assigned asset(s), including executing on the clinical development strategy, study design, monitoring during the conduct of clinical trials, data...
Responsible for setting the vision and mission for the Global Regulatory Operations &GRA Excellence function. The head of GRO and GRA Excellence will represent the department...
Responsible for the planning, execution and delivery of assigned clinical operational activities in conduct of clinical trial(s); Ensuring all deliverables are met within defined...
You will play a crucial role for leading the development and execution of the Global Medical Affairs strategic and tactical plans for PTH program (Brand Team Medical Lead) as well...
Lead the Design Control process for drug/device combination products and create phase-based Design Control documents (DDP, URS, DRS, DV&V, DTx, DHF, etc.). Determine the...
Ensure appropriate affiliate resourcing, skills and capabilities are in place to support affiliate, regional and global medical affairs activities, global research, and development...
You will lead the clinical development strategy and be responsible for designing and executing clinical development plans for MR Imaging assigned contrast agents...
You will provide therapeutic and drug development expertise and interact with Sponsors and investigative sites on protocol medical issues. Contribute to investigator meeting...