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Manage communications with the US FDA, Health Canada, notified bodies and other regulatory agencies/authorities. Conduct regulatory research. B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry.
$108,700 - $118,700 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Reporting to the Executive Director in Organon's Regulatory Chemistry, Manufacturing and Controls (CMC) New Products, the Senior Scientist is responsible for implementing Regulatory Chemistry, Manufacturing & Controls strategies for assigned biological products including biosimilars in accordance with global regulations, guidances and defined regulatory strategies.
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We provide a complete turnkey service managing environmental affairs involving emergency spill response, remediation, regulatory reporting, and waste management. Performs periodic field investigations as needed to build and maintain necessary databases to verify regulatory compliance.
Full-timeRemoteExpandUpdated 1 month ago - UpvoteDownvoteShare Job
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Additionally, you will support business technology and migration consulting projects, primarily in Regulatory Affairs. The company is widely regarded as a leader in providing business consulting, systems integration, and ongoing support services focused on Content Services and its applicability to business-critical solutions, including RIM, Regulatory, Clinical and QMS. fme is partnered with the leading Business Solutions and ECM vendors supporting the Life sciences industry, including Veeva Vault, OpenText Documentum, Generis CARA, Honeywell TrackWise and TrackWise Digital, and Alfresco.
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Responsible for management of the delivery of legal services to support, globally, business operations and functional areas for Medical & Scientific Affairs (MSA) and Quality Assurance & Regulatory Affairs (QARA) activities.
$178,425 - $285,480 a yearFull-timeExpandUpdated 1 month ago - UpvoteDownvoteShare Job
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MSLs are expected to work closely with the Manager of Medical Affairs and the Science Writer & Content Manager to contribute to multiple abstracts and publications each year. The MSL will aid other members of the Medical Affairs team in development of scientific content, and the MSL is responsible for organizing and delivering continuing education (CME/CEU) presentations.
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Provide administrative support to the Associate Dean of Student Affairs for Planning, Operations, and Assessment. Serve on a Student Affairs Emergency Response Team. As a member of the Vice President for Student Affairs office staff; share general office functions for the suite with other members of the team.
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Ensure that correspondence from the Ombudsman or other Regulatory body is appropriately dealt with, that documentation provided is relevant, appropriate, and of high quality, and that responses are made within the required SLAs.
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Minimum of 3 – 5 years’ experience in a regulated industry; pharmaceutical quality assurance or regulatory affairs experience highly desired. The Publishing and Documentation Manager works with RA management, the sales team, supply chain, pharmacovigilance, and others to develop and implement a regulatory document management system utilizing Master Control and to support the electronic publishing and submission of product applications, amendments, and supplements to health authorities.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
$2,651 a weekFull-timeExpandUpdated 1 month ago - UpvoteDownvoteShare Job
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The Senior Medical Science Liaison (Sr MSL) is a field-based position of Medical Affairs that supports and represents PTC and its products with, and to, key opinion leaders (KOLs), clinicians, academic institutions, and professional organizations.
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Demonstrated track record of success in managing complex bridge construction projects. Our valued client is urgently seeking a seasoned Heavy Civil Superintendent with 7+ years of experience in bridge construction to lead projects from start to finish in Pennsylvania.
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Demonstrate a working knowledge of current security compliance requirements involving Department of Homeland Security (DHS), Federal Energy Regulatory Commission (FERC), North American Electric Reliability Corporation (NERC), State Utility Commission, Transportation Security Administration, State and Local Law Enforcement and within the natural gas, renewable energy, and electric sectors.
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Ensures that paper and electronic medical record keeping meet current Cedarbrook policy and industry standards while making recommendations to improve existing policies and processes. Epic EHR, Matrix Care, and/or PointClickCare (PCC) are preferred with PCC administration experience being highly preferred.
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1+ year of relevant OneStream experience or comparable experience performing software development, demonstrating a track record of successful project delivery. Experience with Hyperion, OneStream, or SAP BPC Financial Reporting development, to bring valuable insights and expertise to the role.
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regulatory affairs record keeping jobs Title: regulatory affairs coordinator in Center Valley, PA
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