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Specialist professional individual contributor with comprehensive knowledge in the area of Medical Affairs.
Ability to execute highly complex or specialized projects.
Adapts precedent and may make significant departures from traditional approaches to develop solutions.
u2022 As the Specialist in the Medical Affairs Sub-Function, considered as highly experienced and knowledgeable resource within the organization in overseeing the direction, planning, execution, clinical trials/research and the data collection activities.
u2022 Contributes to implementation of clinical protocols, and facilitates completion of final reports.
u2022 Recruits clinical investigators and negotiates study design and costs.
u2022 Responsible for directing human clinical trials, phases III & IV for company products under development.
u2022 Participates in adverse event reporting and safety responsibilities monitoring.
u2022 Coordinates and provides reporting information for reports submitted to the regulatory agencies.
u2022 Monitors adherence to protocols and determines study completion.
u2022 Coordinates and oversees investigator initiations and group studies.
u2022 May participate in adverse event reporting and safety responsibilities monitoring.
u2022 May act as consultant/liaison with other corporations when working under licensing agreements.
Associates Degree (u00B1 13 years)
Minimum 7 years
Job ID: 147773363
Skills:
clinical protocols , Clinical Trials, Data Collection, Adverse Event Reporting
Skills:
Medical Affairs, Medical Advisor, Clinical Trials
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