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The person will work directly with stakeholders across – ESG Investments, ESG Product Strategy, ESG Data and Operations, Client, Product and Regulatory Reporting, and Enterprise Risk Management to understand their data and reporting requirements and to translate requirements into functional specifications for technology partners building/ enhancing IT solutions for ESG reporting.
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Oversee the management of the Residential and Consumer loan servicing areas of the Bank including investor reporting, loan boarding, funding, escrow processing, HMDA reporting and other general servicing functions; continuously analyzing systems and programs to provide opportunities and advancements in providing quality service.
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Reporting to the Vice President of Clinical Operations, the Trial Master File (TMF) Associate Director / Director serves a key role, working across the organization for the execution of TMF Operations processes and strategy.
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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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Lead the cross functional study team for the EDODM1 Phase 1 study, including clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally.
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The CRA/CRC I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.
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Minimum of 15 years professional working experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience with at least 5 years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections.
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Additionally, the Practice Manager actively participates in all regulatory requirements, assures compliance with Dana Farber Cancer Institute’s policy and procedures, quality improvements projects and institute initiatives.
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Reporting to the Associate Director, Drug Safety and Pharmacovigilance Compliance and Operations, you will play a pivotal role in drug safety activities, supporting records management and compliance across the clinical development and marketing programs.
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Manages reporting of appropriate adverse events to regulatory agencies, including DPH and BRM QPS division, and coordinates unannounced hospital surveys by DPH. Manages investigations related to adverse events, including interviewing staff and reviewing medical records for evaluation of clinical improvement and regulatory/liability reporting.
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As the Director of Regulatory Affairs Operations, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will develop and lead global regulatory operations to support the advancement of multiple clinical trials.
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As a Senior Software Engineer you will work within the Regulatory Reporting Technology team to build and maintain mission critical brokerage applications for the enterprise. As a team we partner closely with Fidelity Capital Markets (FCM) to build and maintain regulatory reporting capabilities to meet the strict requirements of our regulators.
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Dragonfly Therapeutics is seeking a Senior Director, reporting directly to the Senior Vice President, Head of Regulatory Affairs, to join the regulatory team within our Regulatory Affairs organization.
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Advising the business on regulatory requirements, developments and expectations across the swap dealer regimes including swap data reporting, business conduct, recordkeeping, margin and other areas.
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Reporting into the General Director, Financial Reporting/SOX Compliance, this role is critical to meeting the regulatory reporting requirements of the John Hancock mutual funds.
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regulatory reporting jobs in Waltham, MA
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