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Experience with highly regulated industries / understanding of global regulatory expectations regarding Know Your Customer/Bank Secrecy Act, anti-money laundering, Office of Foreign Asset Control (OFAC) sanctions, and Foreign Corrupt Practices Act (FCPA.
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The Global Trial Lead (GTL) is accountable and provides operational expertise for the successful cross-functional delivery of assigned global oncology clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements by taking an operational leadership role in a matrix organization.
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Independent auditing of laboratory data to ensure that regulatory compliance is maintained. Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia, etc.
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Minimum 5 years of employment in clinical development, drug safety or regulatory or equivalent. They will be responsible for leading all interactions regarding product safety issues with Research and Development (R&D) governance committees and regulatory agencies.
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Education:Required: MD, DO, or equivalentPreferred: Board CertificationRequired Experience and Skills:Minimum 3 years clinical practice experience following post-graduate medical trainingExperience in drug developmentMinimum 3 years of experience in clinical safety, pharmacovigilance and/or risk managementMinimum 5 years of employment in clinical development, drug safety or regulatory or equivalentDemonstrated organizational leadership skills, preferably in the employment areas noted above.
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B) Global Regulatory Affairs and Clinical Safety : Focus on late-stage and lifecycle drug activities, understand key regulatory policies and the procedures for interacting with health agencies (e.g. FDA); understand key elements in pharmacovigilance, drug safety monitoring, signal detection and processing of adverse reports After a successful first year, the Physician Scientist will be equipped to assume a leading role in the team with additional responsibilities and interactions.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Analyze safety issues from various sources including Designated Medical Events (DME) and Events of Interest (EVOI), preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data.
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Knowledge of Good Clinical Practices ICH/GCP, drug development process, regulatory requirements for the conduct of high-quality clinical trials including protocol development, medical review, oversight of study conduct, data quality and safety is preferred.
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This position requires exposure to and expertise in areas of cutting-edge molecular biology, NGS technology, bioinformatics/biostatistics, and regulatory affairs. Good knowledge of molecular biology and/or biochemistry and/or next-generation sequencing (NGS) and genomics.
$93,000 - $149,000 a yearExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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As the Food Import Logistics Coordinator, you will be responsible for managing all aspects of our logistics operations, including coordinating with suppliers, arranging transportation and shipping, managing inventory, and ensuring that all regulatory requirements are met.
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As our Logistics Coordinator, you will be responsible for managing all aspects of our logistics operations, including coordinating with suppliers, arranging transportation and shipping, managing inventory, and ensuring that all regulatory requirements are met.
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Compliance and Regulatory Oversight Stay up-to-date with cannabis industry regulations and ensure compliance in all financial institutions. Risk Management Identify, assess, and mitigate financial risks, including credit risk, market risk and regulatory compliance.
$125,000 - $150,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Desired skills and experience: Must meet basic requirements of local child care regulatory agencyKnowledge of the social, emotional and creative needs of young childrenMust be able to lift up to 35 lbs.
$18 - $20 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Coordinate matters and work closely with the IP, Compliance, Regulatory, and Data Privacy counsel. Depending on prior experience and interest to expand the scope of responsibilities, assist with managing litigation and/or regulatory matters for the Company and/or advise on general compliance questions and questions under local civil, commercial, corporate, conflicts of interest, data protection, and privacy laws.
$106,400 - $125,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The ideal candidate will have a proven track record for developing optimal renewable energy supply solutions by creatively leveraging their skills and significant experience across a spectrum of renewable energy supply issues including project development, finance, commercial, regulatory, market, technical, legal, and tax.
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