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Responsibilities: Develop and execute global clinical development strategy, and communication of the global scientific/medical evidence plan for multiple indications Provide clinical/scientific input during the development and execution of clinical trials, including key observational studies Provide clinical content input to: Regulatory …..
Support various pharmacovigilance and risk management/minimization activities for investigational and marketed products Responsibilities: Author and coordinate/project manage development of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc) Support preparation and maintenance of Risk Management plans Contribute to development of signal …..
The Director leads the project teams to design and implement clinical studies at high quality and in a time- and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines. Responsibilities: Provide medical monitoring …..