- Telhio Credit Union (Columbus, OH)
- …complaints, findings, external audit recommendations, and guidance and findings from regulatory examiners and regulators. Evaluate and advise on changes to policies ... Coordinate internal audit activities with external auditors and with regulatory examiners Continue professional development through training and participation in… more
- Amplifybio, LLC (Columbus, OH)
- …actions.Complete and maintain training to remain compliant with all regulatory and health/safety requirements.Train less experienced staff as needed.Assists other ... and in a collaborative team environment.Ability to follow all appropriate regulatory requirements to ensure experimental data are accurately recorded and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, and ... compliant drug/diagnostic regulatory strategies and approaches across geographies.Under direction of the...long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid… more
- Amplifybio, LLC (New Albany, OH)
- …and gene editing to purification and formulation, ensuring adherence to regulatory standards and maintaining product quality and consistency. The incumbent ... review, deviation management, and change control processes, to ensure regulatory compliance and product quality.Production Planning:Develop and execute production… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... related drug/vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and our company's Research… more
- Merck & Co. (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... reporting and interpretation of dataMaintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
- BioAgilytix (Boston, MA)
- …in a technical discipline to verify conformance to applicable SOPs, protocols, and regulatory requirementsWrites QA SOPs and provides regulatory input for other ... ensure resolutionNotifies management of quality/compliance trends and service failuresMonitors regulatory and industry trends/actions and reports regularly to QA… more
- Amplifybio, LLC (New Albany, OH)
- …of cell and gene therapy products, ensuring compliance with regulatory requirements and industry standards.Collaborate closely with internal stakeholders, including ... manufacturing, quality assurance, regulatory affairs, and project management teams, to ensure seamless...to take care of our own.Health, Dental, and Vision insurance that starts on your first day at AmplifyBio!Competitive… more
- Merck & Co. (Rahway, NJ)
- …work closely with other analytical groups in ARD , Global Quality and Regulatory Affairs-CMC to ensure that validated methods are appropriately transferred from our ... issue management and mitigation plan developmentSupport subject matter experts and regulatory colleagues in authoring of relevant regulatory submission… more
- Merck & Co. (Rahway, NJ)
- …and Global Workplace & Enterprise Services (GWES) to ensure compliance with regulatory requirements, corporate standards, policies and procedures related to EHS.- As ... of required reports for the site with respect to divisional and regulatory agency requirements.Manage budgetary & capital needs to support EHS initiatives, projects… more
- Merck & Co. (Rahway, NJ)
- …aspects of the operational business comply with GXP legal and Regulatory Requirements and our company's Animal Health Policies and Procedures.Job ... Qualification)Support our company Animal Health sites in their preparation for Regulatory Agency Inspections by conducting audits, "Mock Inspections", training and… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring … more
- Merck & Co. (Rahway, NJ)
- …proportional hazards models. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),...long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid… more
- Merck & Co. (Rahway, NJ)
- …functions of our company while driving improvements and alignment for regulatory compliance worldwide.Responsibilities: Manage and provide leadership to a team of ... and innovationPreferred Experience and Skills:Robust skills interpreting and applying regulatory frameworks and keeping abreast of the changing regulatory… more
- Merck & Co. (Rahway, NJ)
- …compatibility characterization for processing and administration, and supporting regulatory filings.Build deep fundamental knowledge around the drug product ... to ensure completion of key milestones and laboratory / regulatory documentation.Active strategic and technical leadership on program development teams, interfacing… more
- BioAgilytix (Boston, MA)
- …data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the ... quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based assays, cell work, gene therapy and more.We are looking… more
- Merck & Co. (Rahway, NJ)
- …strategies in clinical trials.Reviewing/writing memos, final reports, related regulatory documentation and publications summarizing data, and reviewing/editing lab ... project teams, biomarker leaders, companion diagnostics leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical… more
- Merck & Co. (Rahway, NJ)
- …pilot plant scale-up and activities to support technology transfer and regulatory filings. The incumbent will be responsible for the performance and ... commercial supply sites and documented in technology transfer documents and regulatory filing submissions. The role maintains awareness of external factors, internal… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific… more
