- 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 Executive Director, Companion Diagnostics/In Vitro… more
- Merck & Co. (North Wales, PA)
- …and different perspectives. Additionally, you will have access to a career development advisor who will offer support and guidance in managing your career. - As ... curious, join us-and start making your impact today. -Overview: The Regulatory Digital Health (RDH) department engages with enterprise leaders across the… more
- USAA (Arvada, CO)
- …and mitigate the risk. Research industry trends and evolving regulatory environment (state and national), improving understanding of important technical/financial ... issues. Use Agency Management Systems/Customer Relations Management (CRM) & multiple carrier Platforms to appropriately select product and carrier offerings. Use Carrier guidelines and processes to partner and negotiate with underwriters on endorsements,… more
- Merck & Co. (Rahway, NJ)
- …and different perspectives. Additionally, you will have access to a career development advisor who will offer support and guidance in managing your career. - As ... intellectually curious, join us-and start making your impact today.-Overview: The Regulatory Planning and Publishing (RPP) Organization within Global Regulatory … 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
- Merck & Co. (North Wales, PA)
- …and interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, organizes, monitors, ... Develops, with input from internal stakeholders and knowledge of current regulatory requirements, article selection, adverse event reporting, editorial, and indexing… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Merck & Co. (Rahway, NJ)
- …& Development Division IT spanning the LROP including Discovery, Clinical and Regulatory .This role also supports the SVP of the Chief Technology Office (CTO) ... of this role include:Leadership & Partnership:Serve as a trusted advisor , and partner to the VP of Research &...ability to act as strategic thought partner and trusted advisor to the businessSkilled in data analysis platforms such… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Analytics Lead, Data Strategy & Management Lead, Dedicated Dashboard Lead and Strategic Advisor . Collaborate on an ongoing basis with the VP, Enterprise Insights, as ... Advanced Analytics functions globally (eg R&D, Clinical, Medical & Regulatory , Finance, Commercial, etc.), in order to effectively increase...at Novo Nordisk North America (NNI). Serves as key advisor to the Executive Team on a routine basis,… more
- Merck & Co. (Durham, NC)
- …be responsible for activities that support Good Manufacturing Practice and regulatory compliance during product manufacturing within the respective VMF's to include ... impact for events.Ensure proper control of materials via product investigationsAssist regulatory groups by providing documentation to support the approval of… more
- Merck & Co. (Rahway, NJ)
- …bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Maintaining a strong network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific… 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)
- …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),...more detail, please contact your HRBP or Talent Acquisition Advisor . Employees working in roles that the Company determines… 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)
- …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. (Durham, NC)
- …activities while ensuring product quality and optimized maintenance processes, regulatory compliance, employee and environmental safety, integration of new/existing ... other departments (Operations, Technical, Automation, Quality)Interacts with representatives from regulatory agenciesInteracts with external vendors/suppliers Education Minimum Requirement: Bachelor's… more
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