- Grifols Shared Services North America, Inc (Fort Worth, TX)
- …of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing ... products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical… more
- Cardinal Health (Austin, TX)
- …of robust stability protocols, testing procedures, and quality systems. The manager will lead cross functional collaborations and possess exceptional communication ... and skill development opportunities. + **Cross-Functional Collaboration:** Collaborate with project managers, Inventory Management, Sourcing, and other Quality Assurance… more
- Sumitomo Pharma (Austin, TX)
- …Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and ... project teams, as required. + Coordinate responses to ad...and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for… more
- Schwan's Company (Houston, TX)
- …seat at the table! We are seeking a skilled and motivated Refrigeration/Amonnia Manager to oversee the operation and maintenance of critical building systems at our ... practices (TPM, TPS) and active participation in capital planning and project execution. Qualifications: + Bachelor's degree or equivalent experience, with 8+… more
- Houston Methodist (Houston, TX)
- …IRB of study closures + Interfaces as needed with appropriate governmental agency on project /products as identified by the Manager . Assists in the preparation of ... Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on… more
- Houston Methodist (Houston, TX)
- …a highly regulated radiopharmaceutical drug manufacturing facility in compliance with FDA cGMP guidance. **PEOPLE ESSENTIAL FUNCTIONS** + Provides work direction of ... research processes to compliant cGMP SOP's and participates in multi-functional project teams as necessary **SERVICE ESSENTIAL FUNCTIONS** + Participates in internal… more
- Bayer (Dallas, TX)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... strategic partnership and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS, etc.) as part of… more
- Fujifilm (Austin, TX)
- …the assistance of technical support, as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Cardinal Health (Austin, TX)
- …systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve ... are being submitted. Manages multiple work assignments in order to meet project timelines. + Drafts submissions for products, ensuring that all relevant product… more
- Fujifilm (Austin, TX)
- …with the Product Support Specialist (PSS) or the Imaging System Project Manager (ISPM) to address incompatibilities/concerns. + Makes recommendations ... changes. + Interfaces with internal and external customers in support of project coordination and to address any challenges/discrepancies that may arise during the… more
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