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A full-service provider, we provides Sanger DNA sequencing, gene synthesis, molecular biology, high throughput/next generation sequencing, bioinformatics, and GLP regulatory services. A full-service provider, we provides Sanger DNA sequencing, gene synthesis, molecular biology, high throughput/next generation sequencing, bioinformatics, and GLP regulatory services.
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As an IMOS analyst within the IBOR Operations oversight team, you will deal with all stages of the lifecycle for each product from broker matching, management of the client’s custodial network, lifecycle events including corporate events, ensuring timely settlement of trades and cash, management of claims and overdrafts, client / regulatory reporting and input into the production of our Investment Book of Record (IBOR) delivery.
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Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF) Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modeling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Monitors and ensures compliance with worldwide regulations, safety reporting to RAs, Investigator/ECs, and Business Partners adhering to regulatory reporting timelines, workflow deliverables, and KPIs for DSPV (including generation of Compliance Reports for the respective activities.
$210,000 - $239,500 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Continuously support Vivarium Operations Management in maintaining compliance with all internal and external regulatory agencies in accordance with the Guide for the Care and Use of Laboratory Animals.
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Provides strategic advice on complex reporting and technological issues raised by the MRTS business units, Regulatory Services Management ("RSM") team, Regulatory Operations teams, and other FINRA customers, as applicable.
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The Office of the General Counsel (OGC) for the Massachusetts Department of Public Health (DPH) is seeking a Chief Deputy General Counsel to lead the policy, programmatic, and litigation efforts within the OGC. As the Chief Deputy General Counsel, you will play a key role in managing, advising, and shaping legal strategies for multiple programs and regulatory matters, particularly focusing on the Bureau of Substance Addiction Services (BSAS.
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Prepare design basis, engineering packages for pilot plant, demonstration plant, and commercial plant, which include PFDs, P&IDs, and process simulation modeling, including utilities requirements, site considerations, environmental permitting, operational considerations, performance requirements, regulatory requirements, and applicable design standards.
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A bachelor's degree or College diploma (graduate degree is considered an asset) from an accredited institution with one of the following (or related) concentrations: Indigenous studies, community development, social and/or environmental policy, regulatory/permitting, environmental or Indian law, environmental science/studies.
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Liaisons with the Institutional Review Board (IRB) for submissions, correspondence, and regulatory binders, including administrative amendments, and continuing reviews. Assists with grant writing and compiling grant application materials in partnership with WRAP Director, WRAP Director of Psychological Services, Grants and Contracts Director, Senior Research Manager, and the Development Office.
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10+ years’ experience in drug safety/pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency. This person will play an integral role in building a Pharmacovigilance infrastructure for a rapidly growing biotech company ensuring that all Pharmacovigilance functional areas are appropriately staffed, all vendor relationships run efficiently, and the Company’s global Pharmacovigilance regulatory requirements are met.
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The Clinical Trial Manager, Site Start-up will lead internal process improvements related to study start up activities to ensure clinical trials are executed with high quality standards in compliance with regulatory requirements, GCP, and company SOPs. This role is based in our Waltham, MA headquarters.
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The candidate who assumes this role will lead a team of compliance professionals supporting execution of the Bank compliance management program, including risk assessments, compliance policies and procedures, training, issues management, complaint administration, regulatory filings, third party risk management and the Community Reinvestment Act (CRA.
$108,000 - $143,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Manages internal Know Your Client “KYC” for new client onboardings, articulating BSA / AML requirements to client based on legal entity type; supports clients in triaging additional information needed to satisfy regulatory requirements.
$130,000 - $169,000 a yearFull-timeExpandApply NowActive JobUpdated Today
regulatory job Title: principal consultant Company: Parexel in Cambridge, MA
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