Job Description
The GCDSE provides clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate.
As the leader of the Clinical (or Extended Clinical) Team, the GCDSE is the clinical representative in global project teams (GPT). The GCDSE is a subject matter expert in the disease area of the programs covered. The GCDSE is accountable for and leads the discussion of CDP and relevant study documents including protocol and results with regulatory authorities, other external bodies such as Independent Data Monitoring committees and Advisory Boards; the GCDSE supports other GCDSE colleagues elsewhere for such interactions with similar bodies, if this responsibility is delegated, while assuring global consistency. The GCDSE is also responsible for country / regional / global interactions with regulatory and public health agencies, governments and supranational non-governmental organizations, key opinion leaders and investigators as required...
As the leader of the Clinical (or Extended Clinical) Team, the GCDSE is the clinical representative in global project teams (GPT). The GCDSE is a subject matter expert in the disease area of the programs covered. The GCDSE is accountable for and leads the discussion of CDP and relevant study documents including protocol and results with regulatory authorities, other external bodies such as Independent Data Monitoring committees and Advisory Boards; the GCDSE supports other GCDSE colleagues elsewhere for such interactions with similar bodies, if this responsibility is delegated, while assuring global consistency. The GCDSE is also responsible for country / regional / global interactions with regulatory and public health agencies, governments and supranational non-governmental organizations, key opinion leaders and investigators as required...
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