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Merck
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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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internal Business Practice & Compliance and Medical-Legal-Regulatory review process ... that also align to the Company’s business objectives.
The Associate Director Marketing for
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Merck
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North Wales, Pennsylvania
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interests from the world’s biomedical literature in support of regulatory, clinical research, marketing, and ... of current regulatory requirements, article selection, adverse event reporting, editorial, and
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Merck
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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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regulatory deliverables for NDA submission and periodic risk-benefit evaluation
Proactively interact ... effective management of product risk profiles across our Research and Development Division pre- and post
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Merck
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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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respond to changing business needs and priorities
Lead CAT to meet pre-launch and launch milestones ... including Global Marketing, Data & Analytics, Policy, Payer Marketing, Global Communications, Regulatory
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Merck
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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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business partners.
Coordinating and leading regulatory interactions with diagnostic partners and/or ... Job Description
Our Diagnostics focused Regulatory Affairs team helps bring new
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Merck
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North Wales, Pennsylvania
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enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... Development Statistics.
Interacts with Clinical, Regulatory, Statistical Programming, Data Management and
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Merck
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North Wales, Pennsylvania
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time constrained situations
Proven ability to drive execution
Business understanding ...
Promotion experience including bringing materials through legal, regulatory, and clinical review
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Merck
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North Wales, Pennsylvania
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challenging promotional concepts that meet business objectives and minimize regulatory risk
Provide ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical
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Merck
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North Wales, Pennsylvania
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enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... related drug/vaccine projects in Late Development Statistics.
Interacts with Clinical, Regulatory
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Merck
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North Wales, Pennsylvania
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enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... Clinical, Regulatory, Statistical Programming, Data Management, and our company's Research Laboratories
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Merck
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North Wales, Pennsylvania
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entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory ... -functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage
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Merck
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North Wales, Pennsylvania
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effective management of product risk profiles across our Research and Development Division pre- and post ... statistical representative and core member in the Risk Management Safety Teams. Lead and provide statistical
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Merck
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North Wales, Pennsylvania
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enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... , Regulatory, Statistical Programming, Data Management, and other Company Research Laboratories Scientists in
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Merck
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North Wales, Pennsylvania
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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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North Wales, Pennsylvania
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, placement, monitoring, analysis, regulatory reporting, and publication.
**Specifically, the Director ... a cross-functional group of experts in commercialization, regulatory affairs, statistics, and
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Merck
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North Wales, Pennsylvania
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and future business opportunities. The position will report to a Director, US Consumer Marketing ... execution and/or business impact
Effective agency and innovative partnership management to drive
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Merck
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North Wales, Pennsylvania
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the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... from individual clinical trials to world-wide regulatory application submissions and post marketing
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