- Legend Biotech USA, Inc. (Baltimore, MD)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr . Cell Therapy Account Specialist - Washington, DC as part of the ... team that will be based Remotely. Role Overview The Sr . Cell Therapy Account Specialist is responsible...in accordance with Corporate, PhRMA, and OIG guidelines. Strict compliance with all regulatory agencies, state, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …functionalities and best practices to drive efficiency and effectiveness while maintaining regulatory compliance . Embrace and promote Agile principles and values ... myeloma. Legend Biotech is seeking a Master Data Governance Sr . Specialist as part of the Technical...processes, create data migration/conversion activities, and ensure adherence to regulatory requirements, including SoX, and CFR Part 21 and… more
- Merck & Co. (Rahway, NJ)
- …products.-- Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements- Serving as regulatory ... ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to...that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory … more
- Merck & Co. (Durham, NC)
- …the automation systems in compliance with cGMPs. The Manufacturing Automation Sr . Specialist must actively support, participate and embrace an empowered team ... Job DescriptionPosition Description: Senior Specialist , Manufacturing Automation The ...(QNs), and other key automation-related processesProviding direct support for regulatory inspections and audits and other validation activities by… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist , Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, organizes, monitors,… more
- Merck & Co. (Rahway, NJ)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Trial Initiation Specialist in Global Site Budgets and Payments ... with Global Clinical Trial Operations to support continuous process improvement and compliance in the spirit of what is best for the business.Track inquiries… more
- Novo Nordisk Inc. (Boulder, CO)
- …improvements that reduce risk and cost to the overall operation. Relationships Specialist , API Manufacturing reports to the Senior Manager, API Manufacturing. ... Essential Functions Responsible for the manufacture of oligonucleotide API ensuring compliance to cGXP, safety, regulatory , and business processes and/or… more
- Stryker (Mahwah, NJ)
- …organization by visiting stryker.com We are currently seeking a ** Senior Staff Regulatory Compliance Specialist ** to join our Joint Replacement Division ... and expectations. **What you will do** As ** Senior Staff Regulatory Compliance Specialist ** , you will support organizational decision on product… more
- City of New York (New York, NY)
- …Social Services NM II, to function as a Program, Policy, and Domestic Violence Regulatory Compliance Specialist who will: Under administrative direction of ... efficiencies in response to agency mandates, increased need for DVS services, regulatory compliance and regular data requests from senior leadership, City… more
- Ultium Cells (Warren, OH)
- …also be responsible for managing and maintaining DOT Special Permits as well as regulatory compliance functions. The specialist will also need to maintain ... This role will also be responsible for supporting future initiatives and maintaining regulatory compliance . The candidate should be adept at conducting risk… more
- Beth Israel Lahey Health (Boston, MA)
- …Shift:** Rotating (United States of America) The Sr . Regulatory Specialist supports regulatory compliance for clinical research conducted by ... data, violations, deviations and submission of other study documents to support regulatory compliance . Troubleshoot processes and procedures when issues are… more
- Amazon (Sunnyvale, CA)
- …Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr . Regulatory Affairs Specialist will be working to build best in ... regulatory timelines. * Partners with quality system leadership to maintain regulatory and quality compliance requirements, including support during … more
- Healgen Scientific Limited (Houston, TX)
- …multiplex flow cytometry. About the role The purpose of a Regulatory Affairs Specialist is to ensure compliance with regulations and guidelines set by ... Regulatory Affairs Specialist Regulatory ...in developing and implementing regulatory strategies, gather regulatory requirements, support compliance activities, and contribute… more
- University of Washington (Seattle, WA)
- …patients in compliance with evolving regulatory requirements. The Billing Compliance & QC Specialist (payroll title: Program Operations Specialist ) ... Trials Office has an outstanding opportunity for a Billing Compliance & QC Specialist to join their...assigned. * Under the guidance of the Manager and Sr . Workflow Lead, provide training for new and existing… more
- Terracon (Austin, TX)
- …want a position with advancement potential? Then join our team as an Environmental Regulatory Compliance Specialist today! This is an excellent opportunity ... * Master's degree **Exemption:** Exempt **Requisition ID:** 27057BR **Posting Title:** Senior Regulatory Compliance Engineer / Scientist **Employment… more
- Teleflex (Wyomissing, PA)
- Sr . Regulatory Affairs Specialist ...audits by as needed. * Participate in and ensure compliance with design controls and review design documentation to ... solutions that make a difference in patients' lives. **Position Summary** The Sr . Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada… more
- Huntington National Bank (Columbus, OH)
- Description Summary: The Risk Management Specialist Sr position will support Regulatory Relations and Reputation Risk. The Risk Management Specialist - ... Senior is responsible for facilitating regulatory exams from start to finish and assisting with the remediation of regulatory findings (Matters Requiring… more
- Medtronic (Minneapolis, MN)
- Position Description: Sr . Regulatory Affairs Specialist for Medtronic, Inc. Minneapolis, MN. Multiple positions available. Responsible for developing ... changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance . Work on PMA (Pre-Market Approval)...closely related field and 2 years' experience as a Regulatory Affairs Specialist , R&D Engineer or related… more
- Teleflex (Maple Grove, MN)
- Sr . Regulatory Affairs Specialist **Date:** Jun 10, 2024 **Location:** Maple Grove, MN, US **Company:** Teleflex **Expected Travel** : None **Requisition ... labeling (product, advertising, instructions for use, and promotional) verbiage to ensure regulatory compliance and substantiated claims. * Interface with the… more
- Kedrion Biopharma, Inc. (Fort Lee, NJ)
- …the patients and clinicians in hematology, immunology, neurology, and transfusion medicine. The ** Sr . Specialist for Regulatory Affair** **s** is responsible ... maintenance of the US dossiers and the execution of lifecycle and regulatory compliance activities of the assigned licensed products in line with business… more
