Alteon Inc. Work Values

Daily Duties at Alteon Inc.:

Directed Quality Assurance Documentation Department, including formatting, reviewing, and typing reports, forms, protocols, SOPs, and annual FDA reports. Supervised organization and management of master documents and FDA submissions (INDs, Amendments, Annual Reports, and MedWatch), managed archive room, developing and managing filing systems and maintaining computer tracking of clinical documents. Maintained master clinical site files for all study trials. Maintained standardization of filing across all studies and document types. Prepared site binders for review and Regulatory/IRB Submission. Data entering into PhaseForward regarding trial information supplied by clinical sites. Provided customer service/assistance to clinical sites participating in clinical trials. Handled regulatory/document room. Conducted co-monitoring (Initial, Site Visits, and Close-Outs) and quality assurance audits for clinical trials. • Transferred all archives between 2 facilities while avoiding workflow or documentation losses. • Enhanced annual FDA reporting process by introduction of new annual report procedures. • Launched SOP system which became company-wide guideline for managing active procedures. • Captained establishment of Quality Assurance Documentation Department. • Instituted process controls for pharmaceutical product development by creating and introducing knowledge management system.

What they like about Alteon Inc.:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

Quality Assurance, Regulatory Affairs, Archiving, Document Management, Clinical

Skills

Regulatory, Archive, and Documentation Systems, Database Creation and Management, Proofreading and Formatting , Computerized Document Tracking , Quality Assurance Department Management, Efficiency Improvements , Batch Record Reviews , Computerized Document Tracking, Master Control, eCopy Desktop, DocuBridge, TrackWise, Citrix, Microsoft Office Suite, SharePoint, Global Records , Documentum, PhaseForward

These are some of the questions we asked our climbers about their experiences with Alteon Inc.: