victoria assadzadeh

* Executed and facilitated the archiving activities for clinical and regulatory, in Central Records to meet ICH and GCP guidelines. * Created processes and procedures for converting paper into electronic files and maintained the archival of Clinical Trial Documentation. * Trained and managed Central Records Assistant on process and procedures relating to Clinical Trail Documentation. * Established process to move Clinical Trial documentation to fully electronic DMS. * Assisted in the development and review of Regulatory Documents and departmental SOPs. * Managed the full in-house library services, including but not limited to reference retrieval and cross referencing. * Created and maintained Livelink EDMS filing of master documents for regulatory and clinical. * Prepared both electronic and paper based Regulatory Submissions utilizing Core Dossier and ISI Toolbox. * Lead for company Livelink Knowledge Manager Group.

Advanced formatting of documents, extensive editing, and proofreading of documents prior to submission to the FDA and other regulatory agencies. Converted submissions into a electronic format adding hyperlinks, bookmarks, headers and footers, and a table of contents; attached graphics, tables and charts to documents.

* Implemented and maintained a Veeva RIMs electronic document management system, establishing appropriate work processes, naming conventions and metadata * Responsible for document migration, quality control * Trained on document creation, workflows and approvals in the EDMS. * Ensured that documentation and record keeping processes conform to GxP and other regulatory requirements, as well as approved procedures * Ensure document management system files remain up to date, validation and risk management * Verified and archived legacy documents and records as needed

* Manage day-to-day regulatory operation functions including the overall planning and management of regulatory operations resources to effectively support timely and quality submissions to regulatory authorities * Represent Regulatory Operations on assigned teams to support submission scheduling and ensure coordination of system development activities * Oversee paper and electronic submissions, eCTD production, document publishing and document management * Maintain a world-class regulatory operation system and standards including publishing and archiving. Develop SOPs and improve on existing processes * Interface with regulatory and clinical project leaders to maintain an overview of upcoming submissions * Accountable for the overall planning and management of Regulatory resources to support global submissions (INDs, CTAs, amendments) * Migrate legacy study reports and data into the document management system. * Conduct cross-functional training on submission standards, procedures, archiving standards and systems as needed

* Provides customers, both internally and externally, with a high level of service with regards to all inquiries, orders and shipments. * Responds to all customer contacts promptly, efficiently and accurately. * Builds and maintains customer relationships. * Assists clients and medical staff throughout the delivery life cycle of ViaCord’s service. * Successfully resolve customer issues including order discrepancies, complaints, billing and shipping issues. * Assure quality, integrity and accuracy of client information (including review, processing, and database entry).

* Supervising staff within the Records Information Management group. * Working with cross functional teams to establish new document classifications. * Managing teams and resources in order to complete tasks in a timely manner. * Providing Quality Control, maintenance, and management of studies. * Lead department for Implementation and Migration of Trial Master Files to new electronic database within the South San Francisco office. * Developing processes for projects and issues found. * Investigating and correcting issues within the Trial Master Files. * Participated as a Lead for the Pilot Study for new Trial Master File. * Training and assisting associates in the submission and classification of Trial Master File documentation.