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regulations and guidelines ( e.g. US FDA, EU Directives, ICH, and National regulations). ROLE RESPONSIBILITIES Assesses compliance of GCP clinical trial sites and processes against ICH GCP and applicable global
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throughout the labeling review and approval process through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external
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ROLE RESPONSIBILITIES Independently authors moderately complex documents compliant with relevant internal processes and standards as well as external regulatory guidance. Manages all aspects of document
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for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be
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. Strong understanding of the drug development process and regulatory submissions. Proficiency in Microsoft Office applications (Word, PowerPoint) and collaborative authoring tools (Endpoint, Starting Point
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revising the label. The LOM provides project management to the Labeling Team throughout the labeling review and approval process through notification to stakeholders in order to ensure that these documents
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May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable Through the Site Care Partner/Country Trial
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cutting edge design and process development capabilities to accelerate and bring the best - in - class medicines to patients around the world. What You Will Achieve In your role, you will be at the center
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Deploy GSSO site strategies by qualifying and activating assigned sites Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list
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cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world. ROLE SUMMARY This position will provide statistical support for