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Merck
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Rahway, New Jersey
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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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Rahway, New Jersey
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that clinical supplies are safe and manufactured with appropriate quality in compliance with regulatory requirements. GDQ achieves this by ensuring that there is a strong foundation of quality systems, qualification
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Merck
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Rahway, New Jersey
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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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Trenton, New Jersey
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quality oversight for clinical trials, participates in the identification of opportunities for process ... ):
Support the CI team which oversees Clinical Quality Management System for trials conducted by GCTO
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Merck
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Rahway, New Jersey
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quality oversight for clinical trials, participates in the identification of opportunities for process ... ):
Support the CI team which oversees Clinical Quality Management System for trials conducted by GCTO
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Merck
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Rahway, New Jersey
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Job Description
Pharmaceutical Operations and Clinical Supply is seeking highly ... Experimentation (FLEx) Center to support drug product development and GMP clinical supply of oral solid dosage
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Merck
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Trenton, New Jersey
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Laboratories is currently recruiting for a summer intern within U.S. Medical Affairs Health Systems. The intern ... Health Systems (e.g., payers, integrated delivery networks) across the entire Company portfolio through
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Merck
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Rahway, New Jersey
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quality of clinical supplies to augment and accelerate our products.
Draft and execute GxP ... and clinical manufacturing facility in Rahway, New Jersey. This team works with non-sterile
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Merck
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Rahway, New Jersey
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Management is a rigorous, data-driven methodology which relies upon high quality market intelligence for ... , specifically in the areas of discovery sciences, preclinical development, clinical development, regulatory
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Merck
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Rahway, New Jersey
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safety and quality of clinical supplies to augment and accelerate our products.
Draft and execute ... and clinical manufacturing facility in Rahway, New Jersey. This team works with non-sterile
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Merck
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Rahway, New Jersey
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's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations & Clinical Supplies (Pharm Ops) organization.
The SLP and FLEx facility supports the formulation and filling of clinical, stability, and
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Merck
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Rahway, New Jersey
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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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Rahway, New Jersey
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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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Rahway, New Jersey
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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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Rahway, New Jersey
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, design control principles and risk management techniques to positively support and influence clinical and ... regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance
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Merck
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Trenton, New Jersey
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Executives, Integration Delivery Systems leaders as well as other members of our Company's extended team ... physicians, physician assistants, nurse practitioners, nurses, pharmacists as well as quality directors and
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Merck
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Rahway, New Jersey
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ones for expansion, efficiency and productivity across drug discovery modalities and clinical phases ... , including scientists, engineers, IT architects, infrastructure, quality, vendors in building, optimizing
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Merck
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Rahway, New Jersey
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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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Rahway, New Jersey
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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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Rahway, New Jersey
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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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