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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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3) Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
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Must be a law school graduate with an LLB or JD degree Must be admitted to the Pennsylvania Bar.5 or more years of experience working with laws and regulations related to litigation, commercial, energy, and/or regulatory law.
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The Quality Manager is also responsible for clinical privilege development and management of the TUHS Medical Staff Affairs Department, internal Credentialing Verification Organization (CVO) which oversees the credentialing of TUHS physicians and APPs working in non-licensed TUHS facilities.
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Bachelor's degree required, with over three years of pharmaceutical/biotech industry experience, including two years in regulatory affairs or operations. Keywords: Regulatory, IND, CTA, SharePoint, Gene Therapy, Cell Therapy, Biotechnology, FDA, Pharmaceutical, Regulatory Submission.
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In addition to the responsibilities above, the Clinical Research Coordinator B will 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.
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The Deputy Director of External Affairs will provide be responsible for communications and recruitment, and scheduling of surge staffing. This role will also support interdepartmental and external affairs on behalf of the Managing Director's Office, with a focus on Election operations and administration.
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Cal Maritime offers seven baccalaureate degrees in Business Administration, Global Studies and Maritime Affairs, Facilities Engineering Technology, Marine Engineering Technology, Mechanical Engineering, Marine Transportation, and Oceanography.
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Collaborates with Student Affairs and Global Centers to support and improve student and exchange visitor services/initiatives. Masters in Public Administration, MBA, Masters in International Relations, Masters in Higher Education, Juris Doctor, or equivalent preferred.
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Represents Jet Aviation as one company internally and externally with industry groups, regulatory bodies and the General Dynamics network. Represents Jet Aviation as one company internally and externally with industry groups, regulatory bodies and the General Dynamics network.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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The Associate Principal Scientist will work closely with individuals from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and correctly executed to support the product strategy.
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Develops/Reviews Stormwater Management Reports and Stormwater Pollution Prevention Plans (SWPPP) to support regulatory permits; Conversant with regulatory codes, design codes and standards, best management practices, permit requirements and construction practices.
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Support the Program Specialist role across PA's IDD programs to ensure regulatory compliance, standardization, and best-practices regarding ISP development/updates, SIS Process, Monthly/Quarterly documentation, Progress/Service Note templates, Health Review Screening Tool, Annual Assessments, and other ODP-mandates.
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The Associate Scientist, Process Development will be responsible for refinement, development, characterization, and assist transfer of product candidates through to Cabaletta's cell therapy CMO. This position will work very closely with internal stakeholders (MSAT, AD, Pre-clinical, QA, CMC, Regulatory) , and require up to 10% domestic travel or occasional weekend and overtime work.
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regulatory affairs jobs Company: Alcorn State University in Cherry Hill, NJ
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