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Merck
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Rahway, New Jersey
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licensing candidate review and works with business development partners in executing regulatory ... Regulatory Affairs and Clinical Safety - Vaccine & Infectious Disease
**Brief Description of Position
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Merck
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Rahway, New Jersey
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). Responsibilities may include serving as a vendor manager, defining and implementing process with vendor ... throughout the business in Research & Development, Information Technology, Quality, Regulatory in pursuit of
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Merck
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Rahway, New Jersey
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Job Description
The Global Ruminants Business Unit Lead is a key leadership role ... President, Livestock Business Unit Lead, the incumbent is responsible to lead, motivate, support, and
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Merck
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Rahway, New Jersey
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Scientists to deliver analytical solutions that enable and accelerate process and product development and ... proactive resourcing planning, risk assessment strategies and will focus on talent development and
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Merck
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Rahway, New Jersey
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we are transforming to better power decision-making across our end-to-end commercialization process, from business development to late lifecycle management. As we endeavor, we are seeking a dynamic talent
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Merck
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Rahway, New Jersey
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enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... supporting drug/vaccine projects.
Interacts with Clinical, Regulatory, Statistical Programming, Data
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Merck
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Rahway, New Jersey
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maintain and develop strong working relationships with network leaders and progress our systems and process ... operational readiness / risk mitigation for clinical MDCP operations in support of current and future MDCP
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Merck
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Rahway, New Jersey
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Product for all large molecules. This leader is expected to contribute to ongoing business process ... leadership and the product/process sciences and engineering. The incumbent will have broad, experience-based
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Merck
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Rahway, New Jersey
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position supports the centralized management of technology, platforms, inspections, and related process and ... ensure it operates in compliance with departmental and company Standard Operating Procedures, regulatory
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Merck
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Rahway, New Jersey
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diagnostic partners: You will work closely with scientists, regulatory experts, and clinical and biomarker ... and managed, communications within and external to the team are effective, risk management plans are
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Merck
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Rahway, New Jersey
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maintain and develop strong working relationships with network leaders and progress our systems and process ... execution of program strategies, improvement initiatives, ensuring operational readiness / risk mitigation
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Merck
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Rahway, New Jersey
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impact on our business operations and ultimately, patient lives.
**Key Responsibilities ... solutions which deliver maximum business value.
Ensure that Content Management Digital Solutions are
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Merck
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Rahway, New Jersey
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, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to ... Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug
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Merck
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Rahway, New Jersey
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of deliverable quality and process compliance.
Ability to anticipate stakeholder and regulatory ... , figures), the span of which range from individual clinical trials to world-wide regulatory application
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Merck
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Rahway, New Jersey
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information provided to investors and regulatory bodies, and the relevance of the financial information and ... understand the company’s performance and enable consolidation of overall financial results and gain business
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Merck
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Rahway, New Jersey
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generate and receive data to support business process, and our Central Technology Organization to develop ... the clinical, regulatory, safety and quality domains. This role will work with stakeholders across the
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Merck
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Rahway, New Jersey
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architecture - ingest, process, make data analytics ready and deliver data to stakeholders
Has overview ... architectural design patterns
Ensure ongoing compliance with regulatory safety, GMP and Validation
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Merck
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Rahway, New Jersey
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business requirements.
Demonstrate an eagerness to learn drug discovery & development processes and regulatory requirements as necessary to solve problems.
Commit to IT infrastructure optimization
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Merck
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Rahway, New Jersey
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Business Enterprise Architecture (BEA), Business Process Modeling, Data Management, Data Modeling ... , Vaccines, safety, and process and analytical R&D efforts. The ideal candidate will possess a deep
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Merck
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Rahway, New Jersey
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access, and provide input into clinical, regulatory, payer/access, marketing and evidence generation ... to business operations, in which case you may not be offered employment, or your employment could be
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Merck
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Rahway, New Jersey
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compliant business standards, process maps, and risk management for global processes across GRACS. The GPL ... managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes
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Merck
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Rahway, New Jersey
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science-based approaches to regulatory interactions and requirements. Uses enhanced business acumen ... Job Description
The Vice President, Regulatory Affairs, General Medicine
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Merck
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Rahway, New Jersey
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, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be ... a cross-functional group of experts in commercialization, regulatory affairs, statistics, and
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Merck
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Rahway, New Jersey
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development, including study design, placement, monitoring, analysis, regulatory reporting, and publication ... commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and
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Merck
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Rahway, New Jersey
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development, including study design, placement, monitoring, analysis, regulatory reporting, and publication ... commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and
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Merck
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Rahway, New Jersey
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focusing on leveraging external suppliers for LM drug substance process development, scale up, full-scale ... , process improvement & innovation, and trouble shooting.
Spot audits and sourcing support on behalf of
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Merck
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Rahway, New Jersey
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, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the Director may be ... with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and
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Merck
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Rahway, New Jersey
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/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory, Quality, and Commercial ... .
Support Quality by Design (QbD) activities and lead discussions on process and analytical risk assessment
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Merck
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Rahway, New Jersey
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enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... , Regulatory, Statistical Programming, Data Management, and our company's Research Laboratories Scientists in
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Merck
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Rahway, New Jersey
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enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... .
Interact with Clinical, Regulatory, Statistical Programming, Data Management, and other company Research
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