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Merck
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North Wales, Pennsylvania
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Job Description
Lead and develops the necessary processes to ensure high quality ... database.
Provide expert guidance on policies and procedures related to quality and compliance of
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Merck
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North Wales, Pennsylvania
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and improve lives around the world. The Global Regulatory Affairs and Clinical Safety (GRACS) Quality ... solid & robust processes and systems that adhere to a regulatory quality & compliance framework
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Merck
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North Wales, Pennsylvania
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), including the Protocol PLS and Results PLS, of clinical studies per our company's processes and standards to ... ** be responsible for :
Authoring accurate, clearand health literate clinical trial PLS
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Merck
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North Wales, Pennsylvania
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Job Description
**2025 US Medical Affairs Health Systems Oncology Internship ... & Development Division is currently recruiting for a summer intern for the U.S. Medical Affairs Health Systems
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Merck
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North Wales, Pennsylvania
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according to quality, compliance and timeliness requirements.
Expertise in SAS and clinical trial ... , Clinical Trial Analysis and Reporting leads the statistical programming activities for multiple and/or
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Merck
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North Wales, Pennsylvania
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and efficacy claims of potential medical breakthroughs.
Review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support
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Merck
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North Wales, Pennsylvania
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business partner and vendor PV agreements and leadership of the Global Clinical Safety & Pharmacovigilance ... within and outside of Global Regulatory Affairs and Clinical Safety (GRACS).
Interact closely with
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Merck
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North Wales, Pennsylvania
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Experience as a BSO for Good Clinical Practices (GCP) systems
Experience as a System Business Analyst ... standard operating procedures, corresponding processes, assuring they are of high quality and complaint
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Merck
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North Wales, Pennsylvania
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clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database ... programming activities for late stage drug/vaccine clinical development projects. This may include leadership
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Merck
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North Wales, Pennsylvania
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managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This includes ... training process standards and strategies to ensure optimal quality and compliance in GRACS business
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Merck
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North Wales, Pennsylvania
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programming activities for multiple and/or late stage drug/vaccine clinical development projects ... from individual clinical trials to world-wide regulatory application submissions and post marketing
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