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Contribute and author documents for IND/NDA/CTA and other regulatory documents Provide scientific and technical leadership for successful study related documents and correspondence Ensure each decision affecting study outputs are fully documented in accordance with relevant SOP's and are in compliance with regulatory review Assist in writing and reviewing protocol, synops
Posted 3 days ago
Build and maintain a good business relationship with functional departments Provide quality service/oversight on pertinent GMP functions Review and approve validation documentation and lifecycle documentation Follow SOPs to perform routine activities (periodic review, Data Integrity audit, inventory log maintenance, etc.) and complete related quality documents Assist with
Posted 4 days ago
Collaborate with Medical Affairs colleagues and external vendors to execute asset strategy and tactical plans with appropriate use of resources according to developed timelines Track priority Medical Affairs tactics and performance to goals/budget Provide high quality scientific/clinical input and review of medical content of promotional and medical materials for accuracy
Posted 8 days ago
Manage writing activities across assigned projects, ensuring adherence to the medical writing strategy and alignment with business needs Contribute to project teams as the medical writing expert for pharmacovigilance submission documents Author various deliverables/documents with consideration for pharmacovigilance, corporate, departmental, and quality standards Adhere to
Posted 10 days ago
Perform regular reviews within the eSurveillance system to ensure data quality/performance throughout the life cycle of the study and/or program Provide frequent updates to Leadership and/or Clinical Management Teams on newly identified trends and/or reporting Drive and contribute to the development of new dashboards or metrics Assist and enhance current data review proce
Posted 18 days ago
Serve as a technical expert for the assigned manufacturing process Troubleshoot manufacturing process and equipment Collaborate with Quality Engineering and Production personnel to conduct the root cause analyses of process non conformances and implement corrective actions Research and implement cost reduction projects Assist production, when required Comply with U.S. Foo
Posted 19 days ago
Provide engineering support to be compliant with all design control, quality, company regulations, and national/international regulatory body requirements Understand change control, validation, documentation practices, process control, and design control requirements Participate in and provide manufacturability insight/guidance to the design and development of new product
Posted 19 days ago
Build and maintain a good business relationship with cross functional departments providing quality service and quality oversight on GMP manufacturing area Oversee clinical GMP manufacturing and support with batch disposition Provide thorough review of product release packages to determine acceptability of final batch product quality/disposition Deliver quality oversight
Posted 22 days ago
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