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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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therapeutic class, including competitor labeling, to help guide the team in developing labeling text. The GLL provides project management to the Labeling Team throughout the entire process, from the request
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of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, FDA, or country-specific regulatory environment Demonstrated success in prior scientific/technical
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for applicable countries Demonstrated knowledge of site intelligence at country/cluster level in support of site recommendation Demonstrated knowledge of clinical trial methodology and the drug development process
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developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and guidelines. In this role, you will manage and support the operational process and
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) 3+ years of management/supervisory experience Experience managing projects PHYSICAL/MENTAL REQUIREMENTS This position/role works in an office where physical requirements are consistent with typical
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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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, prioritize multiple demands, and effectively lead in a matrix organization. PHYSICAL/MENTAL REQUIREMENTS NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Travel: approximately ~20% Attendance
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The R&D Manufacturing Process Development team is looking for a Senior Biologics Development Manager. The ideal candidate has a passion for bringing innovative products to the market and understands
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. Proven experience with PLC Allen Bradley/Rockwell/Siemens. Able to define multi-year strategic Automation direction. Collaborate and align with above site/Global teams. PSM Process Safety Management