| Job alert | Jobs 11 - 20 of 795 |
Drug Safety Physician
Dragonfly Therapeutics
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Waltham, MA
... This individual will ensure timely, consistent and accurate safety reporting in accordance with FDA, EMA, and ICH guidelines, applicable regulatory requirements, Good Clinical Practice (GCP) and standard operating procedures (SOPs). Responsibilities ... - Sep 14
Senior Clinical Research Coordinator
US Tech Solutions
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Malden, MA
... with clinical trial protocol Creates standard operating procedures (SOPs) that adhere to all Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations Contributes to the training of clinical trial staff and ... - Sep 23
Senior Manager, Regulatory Affairs (Clinical)
Xenon Careers
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Boston, MA
$141,600 - $179,100
... Provide support to prepare project teams for FDA and other regulatory agency meetings, as required. Actively participate as a member of global regulatory teams and cross-functional project teams. Ensure appropriate planning, tracking, and alignment ... - Sep 01
System Administrator
JVT Advisors
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Woburn, MA, 01813
... Maintain policies and procedures related to IT, Cybersecurity, FDA and SOX regulations. Work with external auditors for ITGC/SOX testing Designs, specifies, configures, installs, and maintains local area network hardware, software, and ... - Sep 14
Manufacturing Floor Supervisor
Pivotal Solutions
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Waltham, MA
... Chemical handling experience Working knowledge of photochemical processes Ability to navigate typical manufacturing guidelines in ISO13485, ISO9001, and associated FDA CFR 820Ability to work in a fast-paced production KPI driven, regulated, ... - Sep 02
Quality Assurance Coordinator - Food Safety and Sanitation
LSG Sky Chefs
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East Boston, MA, 02128
... Role Purpose Statement Primary responsibility is to maintain the "Global Quality System" of LSG Sky Chefs to ensure the Customer Service Center (CSC) is in compliance with customer, Federal Drug Administration (FDA), US Department of Agriculture ... - Sep 22
Director, Clinical Quality
Alkeus Pharmaceuticals, Inc.
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Cambridge, MA, 02140
... For additional information, please visit our website at Responsibilities: Manage the GCP Quality functional area, in compliance with US (FDA) and international regulations and Guidance, to ensure that the appropriate processes, systems and ... - Sep 02
Associate Director, Global Regulatory Affairs Marketed Products
Takeda Pharmaceutical
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Boston, MA, 02298
... Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types such as original NDA/BLAs. ... - Sep 23
Packer
Softpath System LLC
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East Walpole, MA, 02032
19.00
... • Comply with quality system and regulatory agencies: FDA, ISO, OSHA, etc. • Follow all area safety rules and procedures. Preferred Skillsets: • Comfortable working in a fast-paced environment • Attention to detail Problem Solving and ... - Sep 18
Associate Director, Global Regulatory Affairs Marketed Products
Takeda Pharmaceutical
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Boston, MA, 02298
... Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types such as original NDA/BLAs. ... - Sep 23