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.:

The social vibrance of a hiring firm is very important to you. Your ability to make and maintain friendships there is a critical part of your decision. You would likely be dissatisfied with a workplace that is quiet, cold, or otherwise not particularly social. When you investigate a new hiring company, ask recruiters, managers, and potential co-workers about the social life and opportunities there. This is especially important when you are relocating; moving dramatically alters your social sphere both inside and outside the workplace.

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.: