| Job alert | Jobs 11 - 20 of 782 |
Clinical Research Associate III
ACE Partners
–
Boston, MA, 02298
... Familiarity with US FDA CFR and relevant guidelines for conducting clinical trials (e.g., GCP certification or equivalent) Leadership / mentorship experience. - Sep 01
Drug Safety Physician
Dragonfly Therapeutics
–
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
System Administrator
JVT Advisors
–
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
Senior Manager, Regulatory Affairs (Clinical)
Xenon Careers
–
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
Quality Assurance Coordinator - Food Safety and Sanitation
LSG Sky Chefs
–
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.
–
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
Manufacturing Floor Supervisor
Pivotal Solutions
–
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
Associate Director, Global Regulatory Affairs Marketed Products
Takeda Pharmaceutical
–
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
Senior Manager/Associate Director, Quality Control (QC)
Third Rock Ventures
–
Cambridge, MA, 02140
... Knowledge and understanding of cGMP/ ICH/ FDA/ EU guidance and regulations Experience qualifying and managing reference standard and critical reagents to support QC testing Experience with statistical analysis and statistical software is a plus. ... - Sep 22
Associate Director, Global Regulatory Affairs Marketed Products
Takeda Pharmaceutical
–
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