by offering expertise in validation and quality assurance. Serve as a subject matter expert in quality systems, validation... methodologies, and regulatory compliance. Requirements: IT CSV - Validation of IT systems. CQV - Qualification of Equipment...
and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture...., Medidata Rave, Oracle Inform, Veeva, Redcap). Strong understanding of ICH-GCP, FDA regulations, and CDISC standards...
and sampling, assays, specification setting), Supply Chain and Warehouse Management, Validation, and Quality Systems (Deviation... with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems...
companies. The company is widely regarded as a leader in providing business consulting, systems integration and ongoing support... Veeva, OpenText/Documentum, Generis (Cara), Sparta. fme’s priority is client satisfaction and assisting them...
platform (Veeva CRM/Veeva Vault CRM) and related data Ensure that configuration changes in Veeva and related systems adhere... to Neurocrine’s compliance policy Pro-actively identify and recommend updates/changes to optimize Veevasystems Participate...
in machine learning, NLP, recommendation systems, and AI personalization use cases. Proficient in Data Science tools... data (e.g., IQVIA, Veeva, SP, claims, digital marketing) and strong understanding of compliance and privacy considerations...
operations, and clinical trial results. Integrate Veeva Vault Clinical and other CTMS/eTMF systems into the data ecosystem... expertise, experience with Veeva Vault integration, and proficiency in managing clinical results data across complex ecosystems...
Collaborate with cross-functional teams including Systems Engineering, Manufacturing, Human Factors, and Mechanical Design Create.../update standard operating procedures Qualifications: Bachelor's degree in engineering, biomedical, systems, or related...
, tracking, and archival activities. Manage regulatory systems (e.g., Veeva RIM, PromoMats), and serve as internal subject... portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting...
but not limited to: Customer engagement (Veeva Vault CRM), campaign management, branded and unbranded websites, MLR / promotional... asset management (PromoMats). Strong knowledge of systems integration and analytics tools Proven experience in leading...