- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …tools and systems needed for the function including and not limited to CREDO ( document management ), PRISM ( regulatory information management system), ... investigational filings, marketing applications (NDA/MAA), global submissions, and post-marketing lifecycle management as the CMC Regulatory lead. + … more
- Parexel (Austin, TX)
- …+ Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency ... the development of appropriate responses. * Participate in Safety Management Team (SMT) and Global Regulatory Team...manage the review and approval of labeling in a document management system. + Electronic document… more
- Fujifilm (College Station, TX)
- **Position Overview** The Document Control Specialist II has depth and specialized knowledge of cGMP documentation. This position can largely function with minimal ... or no supervisory oversight for routine duties such as document routing, tracking document review and approval process, assessing document related training… more
- Merck (Austin, TX)
- …the Senior Specialist, Regulatory Authoring Business Analyst, will optimize regulatory authoring processes and enhance data management by mapping workflows, ... and enable digitization. + Experience in digitization and data management initiatives in regulated environments, including source- document … more
- Deloitte (Dallas, TX)
- …information and respond to regulatory or litigation requests. + Performs document management and review functions such as reviewing files, preparing indexes, ... service of process. + Inputs data, maintains and updates OGC's litigation matter management system and its service of process tracking database. + Circulates copies… more
- CVS Health (Austin, TX)
- …each and every day. **Position Summary** Under general supervision the Senior Document Writer drafts, reviews, and edits medical, dental and vision plan documents. ... This position will support plan document needs for new business by creating plan documents...with benefit terminology. + General understanding of compliance and regulatory issues (ERISA, HIPAA, ACA, COBRA). + Organizes time… more
- Oracle (Austin, TX)
- …data pipelines). These engineers will be dedicated to MDR documentation, risk management updates, and regulatory alignment-removing this burden from engineering ... risk management files** , hazard analyses, and FMEAs. + Collaborate with Regulatory , MDR Program leadership, and Risk Management TPMs to align documentation… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Scotiabank (Dallas, TX)
- Manager, Bank Regulatory Reporting Projects **Requisition ID:** 238695 **Salary Range:** 76,600.00 - 142,300.00 _Please note that the Salary Range shown is a ... a full range of investment banking, credit and risk management products and services relevant to the financing and...together to drive ambition for every future! **Purpose** Performs regulatory reporting quality control for GBM US Finance ensuring… more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …annual budget, and manage spend. + Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or work practices. + ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...platform. + Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated… more