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New York, United States of America The Senior Director, Model Validation for Santander US Compliance models (Transaction Monitoring, Sanctions Screening, Fraud Risk, etc) will be responsible for leading the independent validation of models used by various Compliance groups in conformance with regulatory guidance on model risk SR11-07 and other regulatory requirements around Compliance models.
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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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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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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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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) and demonstrates compliance with Home Health Foundation policies and procedures. 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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Responsible for psychosocial assessment and intervention in crisis situations that often involve issues of suicide, homicide, family violence, elder or child abuse. Performs other administrative documentation and record keeping, such as accountability and statistical reports, billing forms, student intern evaluations, performance evaluations, etc.
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Assist in growing the company’s hauler selection, DOT compliance, assure compliance with company policies, risk management, DOT andother regulatory requirements. Responsible for on time performance, order accuracy and maintaining and growing overall truck fleet while maintaining DOT compliance.
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Assist regulators and consultants by providing requested information necessary to conduct regulatory/compliance reviews and examinations of the funds assigned. Must have advanced knowledge of regulatory requirements and limitations, and operating policies for mutual fund service providers (i.e. investment adviser, custody, distribution, fund accounting agent, transfer agent, fund administration.
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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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The ideal candidate will have a background in OSHA and EPA regulatory compliance, environmental health & safety program development, risk identification, and compliance auditing. Assist with the implementation and continuous improvement of the Environmental, Health, and Safety programs including but not limited to emergency preparedness, fire safety, environmental compliance, hazardous and biological waste management, industrial hygiene, biosafety, occupational health, respiratory protection, ergonomics, and training.
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Policy and Procedure Review and Development Under the direction of the 340B Program Manager, the 340B Compliance Technician works with the PIC’s to review and improve processes in workflow with regards to 340B integrity.
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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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Your expertise and leadership will be instrumental in navigating the complex regulatory landscape and ensuring compliance with regulatory requirements. Provide regulatory guidance and support to internal teams to ensure compliance with regulatory obligations throughout the organization.
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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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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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regulatory compliance jobs Title: principal in Stoneham, MA
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