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Clinical Director in Translational Medicine, Cardiovascular & Respiratory Early Clinical Development
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As a key member/leader of an early development team, working in close collaboration with internal and external staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) for the design and execution of early clinical development strategy.
$247,700 - $390,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Develop and implement Data Loss Prevention (DLP) policies specifically for Fabric and Power Platform connectors to safeguard sensitive data and ensure compliance with legal and regulatory standards.
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G, clinical operations study team members, regulatory affairs, quality assurance, and information technology) to ensure TMF compliance and quality) Manage the Trial Master file in compliance with regulatory requirements and company SOPs.
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The ideal candidate will have a background in OSHA and EPA regulatory compliance, environmental health & safety program development, risk identification, and compliance auditing. Assist in securing and renewing EHS permits from regulatory agencies.
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Extensive knowledge and experience with developing Cloud Security Frameworks using industry best practices such as those from the Cloud Security Alliance (CSA) and NIST (National Institute of Standards and Technology) CSF (Cyber Security Framework) and regulatory requirements such as HIPAA, HITRUST, and PCI-DSS.
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Responsible for all aspects of project strategy including preclinical, translational, clinical development, patient selection, regulatory, pediatric, intellectual property, CMC and Asian development strategy.
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The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
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Knowledge of regulatory requirements and compliance standards related to procurement activities within the offshore wind sector. Or add your expertise to our supply and trading operations, brokering renewable electricity, green gas, commodities, and CO2 emission allowances from one of our advanced energy trading floors.
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Head up the development team starting at the time of CTA/IND or proof of concept depending on the program, including all functions: clinical, regulatory, biostatistics, program management, clinical operations, tech ops/CMC, clinical pharmacology, research, and preclinical development, to design and execute clinical development plans for assigned projects.
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8+ years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development; both big and small company experience is preferred.
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The Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director and Principal Investigator(s) to complete the regulatory requirements of clinical research projects.
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The Clinical Trials Monitor helps to ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, state, local, as well as the policies and procedures outlined by the Dana-Farber Cancer Institute and Dana-Farber Harvard Cancer Center (DF/HCC) consortium.
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Expert in GCDMP, CDISC standards, regulatory compliance (21 CFR Part 11, GDPR), and proficient in MedDRA and WHO-Drug coding, ensuring adherence to ICH GCP and industry standards. Bachelor’s Degree in Life sciences, including a min of 8 years in CDM, leading critical oncology or immunology projects from startup to database lock, adept at handling data for regulatory submissions, and proficient in Veeva EDC system management with a solid scientific educational background.
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Will work closely with MITLL’s Project Managers, Facilities, and other Departments to ensure regulatory compliance with asbestos projects and guide hazardous material building surveys and abatement contractor’s projects to ensure regulatory compliance; communicate with Federal, State and Local agencies on asbestos related issues with the support of EHS Officers.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Series 07 - FINRA, Series 24 - FINRA.
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regulatory job Title: principal consultant Company: Parexel in Cambridge, MA
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