Responsibilities: Performs data management activities for both clinical studies and development projects as assigned. Ensures the delivery of complete, accurate data that is ready for analysis and regulatory submission. Supports all dat...
Responsibilities: Working knowledge of FDA and European medical device regulations (QSR and ISO) is required. Working knowledge of software validation requirements for software used in the production of medical devices and software used ...
initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle;track...
Responsibilities: Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management. Demonstrate expertise by leading cross-functional teams to identify risks,...
Roles & Responsibilities: Bachelor's degree or equivalent plus 4 +years of related work experience or equivalent combination Engages cross functionally to investigate and document compliance events, ensuring timely resolution to ena...
Responsibilities: Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users....
Responsibilities: Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant. Manages multiple and complex CQV projects, provides status reports and coordinates with ...
Roles & Responsibilities: Responsible for the efficient and effective performance of testing in conformance with regulations and standards. Responsibilities include inspection, analysis of results, determining final disposition of some p...
Job description: The Clinical Research Nurse is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). Assists with the execution of study-related activities of a Phase I clin...
Responsibilities: Develop, implement, and maintain the Integrated Management System in accordance with ISO 9001, ISO 14001, and ISO 45001 standards. Ensure that the IMS documentation is up-to-date and accessible to all relevant personnel...