and approvals in the designated system (e.g., Veeva PromoMats). Assist in the development and maintenance of SOPs and training..., preferably in pharmaceutical, biotech, or medical device sectors. High proficiency in promotional review processes and systems...
from various systems to support audits and inspections including master SOP list and documents in long-term storage or eArchive.... Performs timely data entry as relates to audit / inspection conduct into Trackwise/Veeva and maintains, analyzes...
, Veeva QualityDocs & Training, RIM Vault) Ensure systems are inspection-ready, compliant, and adopted across global Phase... clinical trials. As we scale, the quality, integrity, and usability of our clinical and quality systems are mission-critical...
Systems (Veeva QualityDocs) and Learning Management Systems (ComplianceWire) Working knowledge of GxP regulations, FDA 21 CFR...Tittle: QA Specialist - with Veeva QualityDocs & ComplianceWire Experience Location: Remote Duration: Consultant...
Systems & Optimization: Medidata Rave, Veeva Vault EDC, Oracle Clinical One/Inform, Medrio, REDCap;eCRF design, edit checks...
accrediting organizations, and recently was named in the 2023 Becker's Hospital Review “60 Hospitals and Health Systems with Great... as ensuring accurate data transfers to other systems. **IT certification preferred, Oncore experience preferred OnCore, Velos...
., MasterControl, Veeva, Greenlight Guru, TrackWise, or equivalent). · Familiarity with ISO 13485, FDA 21 CFR 820, and complaint... and organizational skills. · Strong verbal and written communication. · Proficiency in using document management systems...
vendor data sources such as IRT, laboratory, and imaging. Oversee setup of other clinical management systems like IRT... working with Veeva CDMS clinical software solutions. Experience in the life sciences industry and clinical trial processes...
with electronic documentation systems (e.g., Valgenesis, Kneat, Veeva Vault) is a plus. Prior experience supporting regulatory..., equipment (FUE), and process systems. Coordinate with engineering, quality, manufacturing teams and IT to ensure alignment...
certification preferred Experience in quality systems, design controls, labeling, regulatory submissions, and product launch... regulated industry preferred Experience with Veeva and Workfront is a plus Self-motivated individual with excellent...