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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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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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Must be and remain compliant with any and all regulatory requirements for working in the cannabis industry. The Dispensary Associate is responsible for guiding customers through the cannabis purchasing experience, making informed recommendations based on customer's desired outcomes, provide informed and accurate descriptions of our products, and operate with a high level of accuracy in a fast-paced environment.
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Strong technical writing skills and experience creating documents in support of tech transfer and regulatory submissions (e.g., preIND, IND, BLA, etc. Familiarity and understanding of regulatory standards and current best practices, including GMP, ISO, and ICH guidelines.
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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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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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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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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 ideal candidate must be comfortable working independently, managing interactions with and between 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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Position Responsibilities The Associate Director, Regulatory Affairs will develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC. Lead global and/or regional regulatory team on assigned projects.
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If you have any questions, please contact the Office of Faculty Affairs at academic@gse.harvard.edu. By the position start date of July 1, 2025, candidates will possess a doctorate or another terminal degree in human development, psychology, sociology, anthropology, cognitive science, or a related field.
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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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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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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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regulatory affairs jobs Title: sr regulatory affairs in Lexington, MA
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