robust clinical study databases and associated systems. This role also ensures the study build team delivers on the assigned..., and validate clinical study databases using industry-standard Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle...
protocols and reports Participate in ensuring compliance with quality systems, internal SOPs, deviations, OOS, product... preparation Support cGMP compliance audits of internal and GMP suppliers' quality systems Liaise with Regulatory Affairs...
will be responsible for coordinating platform level innovations, automation and advancements within our Veeva Promo mats global review... to date as required. Understand the Content Management ecosystem of IT systems that the business uses. Manage software lifecycle in configuration...
generation for promotional and regulatory documents integrated into clients’ content supply chains (e.g., Veeva Vault PromoMats.... Experience with Pharma content operations and MLR review, and/or deep ecosystem knowledge (e.g., Veeva Vault PromoMats, DAMs...
and developing high-performing QA teams in a fast-paced, matrixed environment. Deep knowledge of phase-appropriate quality systems... input. Proficient in Microsoft Office and quality system tools (e.g., Veeva, TrackWise, MasterControl);familiarity...
that all systems are installed, commissioned, qualified, and maintained in compliance with regulatory requirements, internal quality...-up, and qualification activities. Maintain validation status of systems through the execution of Periodic Reviews...
with minimal supervision. Intermediate skill in MS Office (Word, Excel, PowerPoint, Outlook, Veeva) and CRM type systems.... Gather and analyze data to identify trends, problem areas, or potential improvements. Apply systems, databases, and research...
skills: Smartsheet, Excel, TrackWise, Veeva, SAP Experience in Quality Management Software systems (e.g. Trackwise...
with Veeva, TrackWise, Smartsheet, and MS Office. Desired Skills: Project Management skills. Quality Management skills... number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems...
wise, Veeva, SAP. Nice to have: previous pharma experience. Sr Associate Supply Chain Compliance... in Quality Management Software systems (e.g. Trackwise, EDMQ, etc) Preferred Requirements: Experience in audit / inspection...