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Expert knowledge in cloud architecture, DevSecOps, vulnerability management, and familiarity with regulatory frameworks such as SOC, ISO, and FedRAMP. SS&C Intralinks is currently seeking a Senior Information Security Manager, Risk and Compliance, who will be responsible for enhancing security and compliance across both cloud and traditional data center environments.
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Develop collaborative partnerships with Clinical Operations, Pharmacovigilance, Data Management, Biometrics, Medical Writing and Regulatory Affairs leadership to maintain a current understanding of potential areas of quality risk exposure across all studies.
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The Risk Manager plays an integral role in regulatory and accreditation readiness by assisting with the implementation of the Patient Care Assessment Plan and the Quality Improvement Plan consistent with Board of Trustee approved goals and regulatory and standard setting agencies.
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Assess all GMP, GLP and GCP compliance risks to the clinical development programs and develop and implement risk mitigation measures. Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry.
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The Prior Authorization Specialist (PAS) is an essential role responsible for facilitating exceptional patient experience, by securing authorizations for all scheduled services related to medical and surgical admissions across entities, including BWH OR procedures, BWFH OR procedures, FXB OR procedures and BWH/BWFH Endoscopy Suite procedures in accordance with standards established by the Department, Hospital, Medical Staff, and outside regulatory and accreditation agencies.
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The Senior Vice President of Global Patient Safety & Risk Management will be responsible for leading and scaling a Drug Safety/Risk Management/Pharmacovigilance function commensurate with company P^5x25 goals and strategic priorities.
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The team is responsible for monthly and quarterly financial reporting including NAIC and IFRS reserves, capital, management risk reporting, OSFI regulatory reporting, supporting experience studies and developing and implementing assumption recommendations.
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Professional risk management organization membership recommended, CPHRM certification helpful. Manages reporting of appropriate adverse events to regulatory agencies, including DPH and BRM QPS division, and coordinates unannounced hospital surveys by DPH.
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Your role: The Senior RA Specialist provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as CE Marking per MDD, EU MDR (updating Technical Files), 510(k) Worldwide product registrations, clinical evaluations.
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Responsible for ensuring development programs are operating in compliance with the EU/FDA regulatory requirements and in compliance with company standards. Lead quality risk management activities both internal development programs and at the contract manufacturers organization and manage mitigation plans with the CMO.
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This role will participate in the management of systems relevant to the administration of the Clinical QMS in support of regulatory requirements for application in drug development and clinical trial execution within the Intellia Clinical Organization.
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In partnership with IT Risk and Compliance, ensure BlueRock’s IT Infrastructure and Applications are in a ready state of compliance in adherence to industry and regulatory requirements. This role is responsible for the policies and procedures governing IT Security and Response in partnership with IT Leadership, IT Risk Management & Compliance, and other interested functions.
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Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products.
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Maintains established hospital and department policies and procedures, objectives, quality assurance, safety, environmental and infection control and complies with requirements of accreditation and regulatory agencies.
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West Creek 5 (12075), United States of America, Richmond, VirginiaManager, Cyber Risk & Analysis (Data Protection & Endpoint Security Service)As a Risk Manager in Capital One’s Cyber DPS Operations Team, you will be responsible for supporting the Data Protection governance and risk related activities for the service, including PLA, RCA, Audit, Regulatory, CAMP, TRAs, and Controls testing.
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risk regulatory jobs in Newton Lower Falls, MA
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