Associate Global Development Medical Director - AstraZeneca, plc : Job Details

Supports in the evaluation of the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety. Work cross functionally within clinical product teams (CPT) to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents (such as Global ICF, CRF, TFL shells, etc.)Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions. Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials), addressing questions regarding scientific and protocol procedures from other study team members and investigative sites. Develop relationships with appropriate consultants and key external experts (KEE), study sites,...Medical Director, Development, Clinical Research, Director, Associate, Medical, Healthcare