- Aldevron (Miami, FL)
- …which includes creation, issuance, and reconciliation. Implement control mechanisms, such as document control, change management , and review cycles, to maintain ... and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align… more
- Takeda Pharmaceuticals (Boston, MA)
- …managing regulatory document workflows, inputting information into regulatory information management systems, preparing, checking and tracking ... + Significant experience in global drug development regulations, regulatory submissions, lifecycle management , compliance, business systems technology and… more
- Catalent Pharma Solutions (Harmans, MD)
- …+ Responsible for implementation, management , and enhancements of an electronic Document Management System (eDMS). **The candidate:** + Bachelor in a Life ... lifecycle of controlled documents, including but not limited to: records management system including version control, document distribution, archival, retrieval,… more
- Austal USA (Mobile, AL)
- …timely manner. + Assists in preparing and maintaining status reports/metrics on Data Management / Document Control for the Program. + Interfaces with customers on ... issuing, receiving and tracking drawings to Production, Client and Regulatory Body + Control and issue of all engineering...+ Prefer four years' experience in drawing and technical document control + Demonstrated experience in Data Management… more
- Actalent (Hunt Valley, MD)
- …organizational tasks including oversight and escalation of open tasks and timelines, document management , tracking of tasks, generation of technical reports, and ... the management of paper and electronic records in adherence to document management and retention procedures. + Escalate compliance issues appropriately and… more
- Panasonic Avionics Corporation (Irvine, CA)
- …for production. Technical Support * Supports and assists subject matter experts with document management system and record management procedures in order ... **Overview** Document Control Analyst III **Responsibilities** Our new global...appropriate changes are documented. Maintains change orders, data from regulatory agencies, configuration progression, and third-party documents in internal… more
- Catalent Pharma Solutions (Chelsea, MA)
- …distributions, and archiving; + Provides day-to-day support of the electronic document management system (EDMS), and operational controls to maintain ... industries or relevant comparable background highly preferred; + Experience with Electronic Document Management (EDMS: Documentum ) and Learning Management … more
- Fresenius Medical Center (Tampa, FL)
- …and maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory ... systems designed to ensure compliance with electronic submission requirements and document management systems. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + A… more
- Takeda Pharmaceuticals (Boston, MA)
- …version control of product labeling and other related documentation within the Takeda document management systems. + Ensures QC of IFUs, CCDSs and other ... requirements and guidance for legacy and PLR labels. + Proficiency in Electronic Document Management Systems and End-to-End (E2E) Labeling Tracking Systems to… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Represent NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management , Global Regulatory Affairs (GRA), Regulatory Operations) to ... knowledge. **Job Description** **_Objective / Purpose:_** + Member of the Nonclinical Regulatory Writing and Submissions (NRWS) leadership who drives NRWS vision and… more
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