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The regulatory specialist will monitor IRB compliance and take corrective steps when needed. In addition to the above, the Regulatory Affairs Specialist Senior position will manage activities of and train junior regulatory specialists as well as train CRCs in the larger clinical group and take a leadership role in making sure all regulatory and compliance needs are met across multiple protocols.
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The Senior Compliance Manger will be part of the Core Compliance team and will work under the general direction of the Chief Compliance Officer to lead, develop, and execute the policy governance, compliance monitoring and testing, compliance education, and regulatory change management programs.
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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 Compliance Specialist conducts research, supports internal investigations, draft reports, manages communications with regulatory authorities, and collaborates closely with internal and external subject matter experts working with the enterprise compliance teams.
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The Environmental Regulatory Specialist will ensure all activities and operations are performed in a safe and deliberate manner; and ensure procedural and regulatory compliance.
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Short Description Blood Bank responsibilities of this position include: Coordinates quality improvement and assurance activities in the Blood Bank to ensure safe patient care, compliance with internal policies and procedures, and external (FDA, CAP/AABB, Joint Commission, FACT, NJDOH) regulatory compliance.
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Coordinates quality improvement and assurance activities in the Blood Bank to ensure safe patient care, compliance with internal policies and procedures, and external (FDA, CAP/AABB, Joint Commission, FACT, NJDOH) regulatory compliance.
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Responsible for overall center quality compliance by ensuring the business is inspection ready at all times and meetings with QA to include but not limited to regulatory and customer requirements to ensure the purity and efficacy of the plasma and the safety of donors and employees.
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Overview: Trade Compliance Specialist is responsible for maintaining and evolving the Import Trade Compliance Program to ensure operational competencies and compliant outcomes across all business functions.
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The QA Specialist I will provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.
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They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions.
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GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work®About the Position:Reporting to the Senior Director, GCP Compliance, the GLP Quality Control Specialist is responsible for ensuring compliance with Good Laboratory Practices (GLP) within the organization.
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This position will be involved with ensuring Independence compliance with NCQA accreditation standards, regulatory requirements. Review implementation of new or changed regulatory requirements to help ensure adequacy of controls of oversight activities.
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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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Participates in responding to periodic exams/audits by regulatory bodies and Internal Audit, to determine level of BSA/AML compliance. Represents FCRM as a specialist on internal or external committees as well as on enterprise-wide Regulatory Change Management initiatives, as required.
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compliance specialist regulatory jobs in Cherry Hill, NJ
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