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The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the review and migration of Phase I-V clinical trial investigator site files to the Veeva SiteVault platform.
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It can be valuable for candidates involved in the development and submission of IVD products to regulatory agencies like the FDA.Regulatory Affairs Certification (RAC): A certification in regulatory affairs, such as the RAC from the Regulatory Affairs Professionals Society (RAPS), can be beneficial for candidates involved in FDA IVD application processes.
$118,000 - $147,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The Analyst III - Policy & Regulatory Operations is responsible for Local, State, Federal, contractual and accreditation requirements interpretation, gap analysis, project scope development and initiation, resource planning, risk identification and mitigation, and project implementation, as well as timely comprehensive development, review and maintenance of internal and Provider policies, and other regulatory documents.
$80,059.2 - $106,059.2 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Leads the execution of global CMC regulatory plans, including overseeing the submission preparation process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
$237,660 - $307,560ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Work with Medical Monitor, Data Manager, Safety Manager, Clinical Operations Program Lead, Clinical Trial Manager, Clinical Trial Associate, Principal CRA, and CRO staff to review site specific data listings for accuracy, data discrepancy resolution, and data trends; provide training/retraining to site staff as needed.
$138,500 - $153,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Complete audits to assess accuracy and quality of scientific data submitted to the regulatory agencies in support of in vivo medical devices and in vitro diagnostic devices' application.
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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
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Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Plan, conduct, and lead complex clinical study audits (Sponsor, Investigator Sites and Clinical Suppliers) (either remote or on site) in accordance with all applicable regulations, standards, mentorship, and the established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
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Minimum 2 years of relevant professional experience shall be in clinical auditing. Work experience in positions with significant QA, Regulatory or management systems responsibility. University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology, Human Physiology, Nursing, Quality Management.
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Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Manage audit observations and audit reports through the internal audit database and CAPA process.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
$103,500 - $170,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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We believe that the human element, across our global teams, is what allows us to continually evolve. We have an excellent new opportunity for a Medical Device Lead Auditor to join our global organization.
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Assist the regulatory specialist in preparing for all local and Central Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, modifications, and adverse event reporting and all regulatory documentation with pharmaceutical companies and clinical research organizations (CROs.
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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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clinical data review regulatory affairs jobs Title: clinical scientist
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