- 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
- Butterball (Mulberry, AR)
- …targeted levels of the customer product specifications. Ensures food safety, regulatory and company compliance, and compliance with all established safety ... tasks. Participates in HR activities such as hiring, terminations, performance management , goal setting, team member development, scheduling, etc. Enforces systems,… 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
- Sanofi Group (Morristown, NJ)
- …Demonstrated experience working in and strong knowledge of electronic document management systems to obtain and leverage regulatory deliverables (eg Veeva ... and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional… more
- Lilly (Indianapolis, IN)
- … team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional ... drug /device clinical development and knowledgefromhealth authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies ... strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …molecule drug substances, drug products, and drug -device combination products. + Determine regulatory and scientific/technical requirements ... needed for the function including and not limited to CREDO (doc management ), ORIOM ( regulatory information), Trackwise, TRS Viewer, Concur (expenses), and… more
- Astrix Technology (Springfield, MO)
- ** Document Controller** TMF Document Management...is a global CDMO that is committed to developing drug products as they produce and introduce them into ... equivalent required. + 1-2 years of related experience in document control, administrative support, or a similar role. +... control systems and processes to ensure integrity and regulatory compliance (FDA, OSHA, EPA, DEA, and company policies).… more
- Lilly (Indianapolis, IN)
- …could impact the global product strategy or brand. + Enable discussion of the regulatory strategy document and regulatory issues/challenges at the ... to those who need them, improve the understanding and management of disease, and give back to our communities...(ie, PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience OR… more
- Sanofi Group (Morristown, NJ)
- …planning activities, including generating submission content plans, submission tracking, and document management + The RS participates in the development ... **Job Title:** Regulatory Strategist - mRNA Vaccines **Location** : Swiftwater,...is a plus + Ability to work in electronic document management systems, eg, Veeva Vault is… more
- Catalent Pharma Solutions (Philadelphia, PA)
- **Senior Quality Assurance Document Control** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... patients annually. Catalent Pharma Solutions is hiring a Senior Quality Assurance Document Control. The Senior Quality Assurance Document Control coordinates the… more
- Astrix Technology (Springfield, MO)
- ** Document Control Specialist** Contracts/Outsourcing Springfield, MO, US Pay Rate Low: 18 | Pay Rate High: 20 + Added - 28/04/2025 Apply for Job Our client is a ... global CDMO that is committed to developing drug products as they produce and introduce them into...introduce them into the market. They are seeking a ** Document Control Specialist** to join their team! Located in… more
- Catalent Pharma Solutions (Manassas, VA)
- …and maintenance of the Quality System documentation. Communicate any deviations to management . The ** Document Control Specialist** will assist the Quality ... ** Document Control Specialist** **Position Summary** Catalent, Inc. is...batch production records to verify compliance with internal and regulatory requirements. + Support third-party certifications and customer audits… more
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