- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is ... responsible to support Clinical Inspection Readiness (IR) and pre-approval Inspection preparation activities for global clinical operations, responsible for… more
- Merck & Co. (Durham, NC)
- …last several years; currently Durham employs 1,000+ people.This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... collaboration skills responsible for supporting Operational Readiness projects to support biological processes for a new...product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and risk management for assigned clinical studies, through inspection readiness preparation Responsibilities - Risk Management (Signal identification, evaluation, ... Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs) - Contributes to regulatory authority requests or communication for assigned clinical studies - CTD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and supply forecast of commercial and IMP drug product. Supports regulatory inspection and its readiness . Works diligently with CMO representatives ... the timely release and delivery of pharmaceutical products as per applicable regulatory standards and company expectations for products. The incumbent is responsible… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of ... play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed, monitor 1) procedural compliance metrics to support inspection readiness activities, and 2) procedural deviations to identify potential gaps/deficiencies, ... as appropriate.Work with the Global Training Office to create a CRO Alliance Manager account within our learning management system (LMS) and maintain the curriculum… more
- Sun Pharma (Taro Pharma) (Billerica, MA)
- …Regulations (CMDR SOR/98-282), EU Medical Device Regulation 2017/745. Ensure site readiness for regulatory agency inspections and/or Sun Corporate Audits. ... Area Of Responsibilityas "Management Representative", leading all regulatory inspections related to medical device and combination products (FDA/ISO).Management… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …negotiation and Clinical Study Agreement finalization, Translations, EC and Regulatory submission, Site initiation etc.).Oversee, manage and assess vendor ... carrying out start up (site identification, feasibility, selection, EC submission, contracting and SIV readiness ) for some sites in US for a faster FPI in a Global… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …of improving the health of our communities. About the Role:Job SummaryThe Manager -Data Engineering & Analytics is a highly skilled and experienced leader with ... a focus on cloud technologies and team leadership.In this role, the Manager -Data Engineering & Analytics will interface with all departments to understand… more
- Northeast Georgia Health System, Inc (Braselton, GA)
- …issues related to automated dispensing cabinets. Performs audits to satisfy regulatory agencies requirements. Assist Automation Coordinator/Pharmacy Manager with ... in accordance with population specific guidelines and adheres policy and procedures of regulatory agencies. With a valid intern license, may also perform duties of a… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …in accordance with population specific guidelines and adheres policy and procedures of regulatory agencies. With a valid intern license, may also perform duties of a ... unit to meet the needs of nursing unit, the pharmacy and regulatory agencies. Minimum Job QualificationsLicensure or other certifications: Current registration with… more
- UNC Health Care (Chapel Hill, NC)
- …consistent with professional standards. Reporting and accountable to the Nurse Manager /Director, the Clinical Nurse is responsible for coordinating and delivering ... uses patient education materials relevant to patient population. Assesses readiness to learn of the patient/family/caregivers. Assesses developmental level of… more
- UNC Health Care (Rocky Mount, NC)
- …consistent with professional standards. Reporting and accountable to the Nurse Manager /Director, the Clinical Nurse is responsible for coordinating and delivering ... uses patient education materials relevant to patient population. Assesses readiness to learn of the patient/family/caregivers. Assesses developmental level of… more
- Highmark Health (Pittsburgh, PA)
- …Network **Job Description :** GENERAL OVERVIEW: Create a culture of continuous regulatory readiness through continual proactive risk assessment and mitigation ... and procedures. ESSENTIAL RESPONSIBILITIES: + Create a culture of continuous regulatory readiness through continual proactive measures. Educate all levels… more
- Sanford Health (Fargo, ND)
- …Quantitatively and qualitatively, assesses compliance followed by communicating results. The Manager of Accreditation facilitates regulatory readiness ... in order to lead the specific market to a continual state of regulatory readiness . Collaborates with operational and executive leaders ensuring compliance with… more
- Freeport-McMoRan (Phoenix, AZ)
- Operational Readiness Manager - OM Requisition ID: 132441 Location: Phoenix, AZ, US, 85004-2121 Category: Admin Support Share this Job Why You Should Apply For ... from the design/construction stage into an operating business unit. The Operational Readiness Operations & Maintenance Manager is responsible for developing the… more
- Freeport-McMoRan (Phoenix, AZ)
- Global Operational Readiness Manager Requisition ID: 132262 Location: Phoenix, AZ, US, 85004-2121 Category: Engineering Services Share this Job Why You Should ... the design/construction stage into an operating business unit. The Global Operational Readiness Manager is responsible and accountable for the administration and… more
- Bank of America (New York, NY)
- Sr Relationship Manager II - Global Markets Client Delivery & Onboarding Readiness New York, New York **Job Description:** At Bank of America, we are guided by a ... Business Job Description:** The role covers the Client Delivery & Onboarding Readiness function of client onboarding for Institutional clients across various Fixed… more
- Amazon (Nashville, TN)
- …Data analytics, and using data to tell a story. About the team Program Manager , WHS RME, Technician Readiness Additional Responsibilities: * Support WHS RME ... Description The Workplace Health & Safety (WHS) Program Manager , North American (NA) Reliability Maintenance Engineering (RME)...improve network WHS standards and procedures. The Regional WHS Manager , NA RME supports both the field in program… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are looking for a Director Global Procurement-R&D- Inspection Readiness to be responsible to lead, support and assist in the development and implementation of ... Inspection Readiness tools and processes. Must demonstrate experience in participating...tools and processes. Must demonstrate experience in participating in regulatory inspections, quality and risk management with vendors and… more
