- Cepheid (Miami, FL)
- …for functioning as Lead Internal Auditor to schedule, plan, perform, and document internal audits of Cepheid's Quality Management System (QMS), providing ... the opportunity to:Function as Lead Auditor to schedule, plan, perform, and document internal audits to provide continuous and rigorous assessment of the Cepheid… more
- Amgen (Washington, DC)
- … Information Management System (eg VeevaVault) and support the department in regulatory document management activities. + Maintain regulatory ... these credentials. **Basic Qualifications:** **Must have in depth knowledge of regulatory document management systems including content management and… more
- University of Pennsylvania (Philadelphia, PA)
- …Teams, Zoom, WebEx, BlueJeans etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva ... document tools, as well as, to provide direct regulatory /compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory EDMS and business development support: Provide end-user support for Regulatory electronic document management system (EDMS); Create job aids ... notifications, and rapid response document ; Submission planning and management of Regulatory submissions: Collaborate with cross-functional team members… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …with Regulatory Affairs team(s) to align the IT architecture to facilitate regulatory submissions, document management , and compliance tracking and to ... Compliance domain, which includes: i) Research & Development, ii) Regulatory Affairs, iii) Quality Management and iv) Medical & Scientific Affairs. + Support the… more
- System One (Pittsburgh, PA)
- …Procedures (SOPs), batch records, and other forms according to company standards and regulatory requirements. + Electronic Document Management System (EDMS): ... (preferably cell and gene therapy or biotech). + Proficiency in using electronic document management systems (EDMS). + Strong understanding of Good Documentation… more
- Actalent (Sioux Falls, SD)
- … frameworks + Strong organizational, analytical, and communication skills + Experience with regulatory software and document management systems is a plus ... Regulatory Affairs Specialist Position Overview A dynamic and detail-oriented Regulatory Affairs Specialist is needed to support compliance efforts across… more
- Lilly (Durham, NC)
- … / external environments and advocate / influence quality related policies and regulatory requirements related to Document Management . + Responsible for ... people around the world. **Responsibilities** The Senior Director, Global Process Owner for Document Management , as a leader within the Global Quality Systems… more
- Koniag Government Services (Silver Spring, MD)
- …Koniag IT Systems is seeking an experienced Project Manager to lead our regulatory document and records management projects supporting federal government ... Skills & Abilities:** + Minimum 6 years of project management experience delivering similar regulatory document and records projects, preferably in a… more
- Actalent (Parsippany Troy Hills, NJ)
- …+ In-depth knowledge of GxP-compliant document control practices, including document lifecycle management and regulatory documentation. + Proven ... document authoring standards, reviewer/approver workflows, and best practices within the Document Management System (DMS). + Serve as a DMS administrator,… more
- Fun Town RV (Fort Worth, TX)
- …process binders, ensuring consistent implementation of safety programs across all locations. Regulatory Coordination & Document Management + Process and ... federal, state, and local regulations by coordinating with internal departments and regulatory agencies. The position involves managing a high volume of legal… more
- Charles River Laboratories (Malvern, PA)
- …+ Maintain historical files for SOPs and forms. + Assure that site document management strategies and regulatory requirements for electronic documents ... flow and final release of controlled documents through the document management system. + Serve as the...With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address… more
- Lilly (Philadelphia, PA)
- …/ Manager is responsible for CMC regulatory operations, CMC change management , and document lifecycle management within IMP manufacturing operations. ... task management to ensure compliance with quality management systems + CMC regulatory operations (eg, coordinate regulatory submission timelines, manage… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …in cross-functional teams. + Proficiency with regulatory databases, document control systems, and project management tools **Preferred Qualifications:** ... industry expectations to product strategies and submissions. + Demonstrate strong project management , writing, coordination, and execution of regulatory items. +… more
- Chiesi (Boston, MA)
- …as regulatory -CMC representative. + Maintain submission information according to the document management system, track regulatory CMC commitments & ... is Chiesi." Who we are looking for Purpose Currently seeking for a Regulatory Affairs Specialist to support preparation of CMC related submissions and assessment of… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …in cross-functional teams. + Proficiency with regulatory databases, document control systems, and project management tools. **Preferred Qualifications:** ... **Job Description Summary** As Staff Specialist Regulatory Affairs, you will have a deep understanding...ISO 13485, IEC 62304). + Strong knowledge of risk management processes (ISO 14971) and cybersecurity considerations for medical… more
- Three Saints Bay (Bethesda, MD)
- …customer service. + The Project Manager must have demonstrated ability to manage a regulatory document and records management effort, including a staff of ... manager must have demonstrated ability to plan, integrate, and manage life cycle regulatory document operations involving document processing in high volume… more
- UNC Health Care (Rocky Mount, NC)
- … management functions including chart analysis, CDI, Coding, Revenue Integrity/ Regulatory Services, Document Management , Chart Correction, Forms ... unique communities we serve. Summary: This position is responsible for the overall management responsibility of the Health Information Management of the health… more
- M&T Bank (Buffalo, NY)
- **Overview:** Serves as a member of the Management Development Program (MDP) and participates in ten weeks of Core Training and one year of On-the-Job (OJT) ... in classroom training, observations of departmental presentations, interaction with senior management , peer networking, and working in teams on two group project… more
- Legrand NA (Canonsburg, PA)
- …Control Coordinatorleads the strategic direction and implementation of the organization's document management framework within the Quality Assurance department. ... within one of our largest US facilities. Primary Responsibilities: + Document Management Strategy:Develop and implement long-term strategies to enhance… more
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