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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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The Data Center Technician III assists in the operational integrity, security, and regulatory compliance of the data center. These systems include, transformers, PLC's, generators, switchgear, UPS systems, STS', ATS' PDU's, chilled water systems, CRAC/CRAH, wet sprinkler systems and pre-action sprinkler, network equipment, transmission media, cabling infrastructure, security hardware, and CCTV.
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O Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.
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Ensure compliance regulatory compliance with respective contract and model fidelity in conjunction with program leadership and Quality Assurance Team and VP of Homeless Services including State and Federal outcomes reports, third party billing, and HMIS data collection and reporting.
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What You’ll Do: Reporting to the Lead Clinical Research Associate, the CRA II/Sr. CRA will perform quality and compliant Investigator site monitoring and relationship-driven Investigator site management in line with MapLight’s SOPs, our Mission, Vision, and Values, as well as industry quality and regulatory best practices (ICH GCP.
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Understands and adheres to all Bank Secrecy Act and Anti-Money Laundering (BSA/AML), regulatory, security, retail banking and bank-wide policies and procedures. Understands and adheres to all Bank Secrecy Act and Anti-Money Laundering (BSA/AML), regulatory, security, retail banking and bank-wide policies and procedures.
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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 Program Leader will lead a cross-functional matrix team consisting of functional representatives from clinical development, clinical operations, regulatory affairs, translational medicine, clinical pharmacology, clinical biomarkers, CMC, non-clinical sciences, and medical affairs to deliver against an ambitious program strategy.
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The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
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This includes all documentation, regulatory compliance, patient care, and customer service skills required to complete molecular imaging procedures. This includes all documentation, regulatory compliance, patient care, and customer service skills required to complete molecular imaging procedures.
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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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Minimum of 10 years of experience in site assessment and restoration working under the provisions of the MCP (Massachusetts Contingency Program) or other state regulatory programs, CERCLA and RCRA with experience managing HTRW type Federal projects.
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QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
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Partner with Quality, CMC Regulatory and SMEs to assess compliance with regulatory guidelines and industry best practices for US and EU markets. Experience and/or familiarity with regulatory guidelines (ex.
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The Flagship Communications and Public Affairs team is responsible for overseeing all aspects of communications, government and regulatory affairs, and social impact. Participate in weekly Communications & Public Affairs team meetings and collaborate with team members as needed to support both PBU work and corporate communications activity including events, government relations, digital, internal communications, and media relations.
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regulatory job Title: sr regulatory affairs associate in Lexington, MA
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