launch‑ready and compliant across the U.S., Canada, EU, and beyond. You will help shape the processes, systems...;experience with regulatory platforms such as WERCS, Veeva Vault, or SAP EHS is a plus. Strong analytical, organizational...
and project teams. Experience with Development systems and processes (e.g. eTMF, CTMS, eCRF, eSubmission, eCTD, SAS, Documentum..., Veeva for R&D, etc..). Strong analytical and critical thinking skills Strong architectural and application development...
. Proficiency with document management systems (e.g. SharePoint, Veeva MedComms, SmartSheets) preferred and familiarity with digital...
Preferred Experience and Skills: Experience with digital asset management systems Familiarity with Veeva PromoMats... team and will be responsible for providing document approval in our digital asset management system, Veeva PromoMats. The...
and workflow systems (e.g., Veeva, eTMF, CTMS, electronic review tools) Proven collaboration with Clinical, Biostatistics...
, purification systems, lyophilizers, and analytical instrumentation In collaboration with Chemical Development, transfer and scale... and guidelines Working knowledge of control software for automated oligonucleotide synthesizers and/or chromatography systems...
) skills Must have full working experience in MS Word, PowerPoint, Excel, document management systems (e., Veeva...) and regulatory information management systems a plus Excellent writing and communication skills Must have strong negotiation skills...
instruments and consumables. As applicable, utilize company systems for entry and tracking of regulatory activities. Manage... experience. Knowledge of SAP, Veeva Vault and Trackwise preferred Strong verbal and written communication and organizational...
to work with a CRM tool (i.e., Veeva, Salesforce) Independent, with an ability to work within a team Strong Leadership... systems #LI-Remote Physical & Mental Requirements: The physical demands described here are representative...
experience utilizing enterprise systems such as Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS) to support quality oversight...