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The ideal candidate will have a solid understanding of Anti-Money Laundering (AML) and Bank Secrecy Act (BSA) laws; regulatory consent order action plans and artifact validation; risk and control matrices; and design/operational effectiveness testing.
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Compliance and Regulatory Oversight: In collaboration with organizational risk management and compliance leadership, ensures compliance with all federal, state, and local regulations governing FQHC operations, including HRSA, DPH, CMS, HIPAA, and NCQA PCMH requirements and standards.
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Oversee quality assurance activities to ensure the integrity, accuracy, and compliance of clinical trial data within Veeva Vault applications, in accordance with regulatory requirements (e.g., FDA guidelines, GCP standards.
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Lead identification of assay requirements, lab selection, and contract development to ensure regulatory compliance according to GLP, GCP, and applicable global regulatory requirements such as CLIA and EU IVDR, and execution feasibility.
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As an Anti-Money Laundering (AML) Compliance Senior Manager, you will lead the AML program strategy, including reporting, advisory, and governance, to ensure industry-leading performance and compliance with all regulations.
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Analytical Skill, Analytical Skill, Analytical Thinking, Anesthesia, Animal Models, Animal Testing, Animal Welfare, Biology, Chemistry, Clinical Pharmacology Skills, Collaboration, Communication Skills, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Ethics, Laboratory Equipment, Life Sciences, Organization, Pain Management, Pharmacology, Problem Solving Skills, Project Teams, Regulatory Compliance {+ 5 more.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Familiarity with regulatory requirements and compliance in equity capital markets. This is a brand-new role for the firm, reporting to our CO-Chief Investment Officer and will offer an exciting opportunity to become a pivotal partner in shaping our equity capital markets strategy.
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Demonstrates compliance with regulatory requirements i.e. MIPS, fall assessment. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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Ensures ongoing compliance with all applicable regulatory agencies for department section (including but not limited to: CLIA, TJC, OSHA, DPH, HCFA, FDA, AABB, NCCLS). Maintains updated Policy and Procedure Manuals using the NCCLS format in compliance with regulatory agencies ensuring documentation of Supervisor and Medical Director review annually and at revision.
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Research regulatory issues and respond to BSA related compliance questions fromcredit union personnel, using legal and regulatory reference materials, regulatory agencies, legal counsel, and professional associations and organizations.
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Ability to interpret microbiological environmental monitoring results in terms of risk assessment and regulatory compliance. Manages the DFCI Biosafety Communications Program by identifying topics relevant to investigators with biosafety protocols such as upcoming modifications to IRIS for human gene therapy clinical trials and iRIS-IBC for laboratory registrations and any regulatory and DFCI policy updates, training requirements, resources and guidance, and those requested by the Director of Biosafety.
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Ensure the e-QS Veeva Vault is maintained in accordance with current regulatory compliance requirements and meets current corporate quality and business objectives. Experience with Veeva Quality Vault eDS/eQS and Compliance Wire eLMS required.
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Familiarity with programming for data analysis; ideally Python, SQL, or R.Experience working hands-on with other cross-functional team leaders, such as lawyers, engineers, product managers, data scientists and operations teams in improving compliance processes and systems.
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We are accountable for enabling our programs in early research to reach development candidate nomination through regulatory filing and into clinical trials. How you will Achieve More with Intellia:Intellia is look for a Director, Genotoxicity Regulatory Lead to support the advancement of genome editing products into the clinic.
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regulatory compliance jobs Title: principal in Cambridge, MA
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