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Understanding in single case processing, aggregate data review and evaluation of drug safety issues, adverse event dictionaries, literature publications, core labeling, and Periodic Safety Review preparation is required.
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Enterprise Model Risk Management seeks a Senior Quantitative Finance Analyst – Liquidity Risk to conduct independent testing and review of complex models used to monitor and mitigate liquidity and funding risks in the Bank. Responsible for compliance with Enhanced Prudential Standards and other regulatory guidelines, the candidate will work on models related to both banking and trading businesses of Bank of America.
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Oversee, prepare, and/or review aggregate safety review documents (e.g., Development Safety Update Reports [DSUR], Periodic Benefit-Risk Evaluation Reports [PBRER]) and safety sections of relevant clinical trial documents (e.g., protocols, clinical study reports [CSR], investigator brochures [IB], informed consent forms [ICF]) and regulatory filings (e.g., clinical trial applications [CTA], marketing authorization applications [MAA.
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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). Where permitted by federal or state law, Fidelity will also conduct a pre-employment drug screen, which will review for the following substances: Amphetamines, THC (marijuana), cocaine, opiates, phencyclidine.
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Oversee the preparation, review, and submission of CMC regulatory documentation, including detailed CMC sections for INDs (Investigational New Drug Applications), NDAs (New Drug Applications), BLAs (Biologics License Applications), and MAAs (Marketing Authorisation Applications.
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Review, prepare, submit, and manage Export/Import Authorizations (Licenses: DSP-5, DSP-85, DSP-73, DSP-61, BIS-748P Licenses; Agreements: MLAs and TAAs; Exemptions/Exceptions) to authorize the transfer of regulated hardware, technical data, software, and services.
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We are currently seeking a Managing Editor, preferably with prior experience in Managed Care and peer-review. Review story pitches and determine appropriateness for acceptance based on established content strategy.
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Responsible for accurately reviewing, processing, and docketing all Litigation documents received from court orders, as well as arbitration review panels, maintenance of Litigation records, and related docket entries in the Firm’s electronic docketing system.
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Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan, ICF, CSR, responses to HA or institutional review board/ ethics committee queries.
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Review of municipal subdivision and land development applications, traffic impact and circulation studies, zoning ordinances. Work with multi-disciplinary teams on tasks such as traffic studies, corridor planning, feasibility studies, safety audits, intersection design, traffic signal design, roadway signing and pavement marking plans, DOT access permitting, Signage and striping plans and traffic and signal operations analysis.
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Rider University is consistently highly ranked as a best college by U.S. News and World Report and The Princeton Review for student success, academic programs, veteran friendliness, and its sustainability efforts.
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Lead development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, and safety-focused publication development.
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3+ years of experience conducting the following activities: Business requirements gathering, fit-gap analysis, functional design process, system testing and solution delivery, UAT customer support, process document creations and review, working with onsite and offshore delivery model.
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Rider University is committed to fostering an inclusive, vibrant living and learning community that embraces students, faculty, and staff of all backgrounds and enables them to achieve success. Rider University is an Equal Opportunity/Affirmative Action employer dedicated to excellence through diversity.
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Assist with the development and execution of value communications initiatives for franchise, including non-branded and branded initiatives – examples include but are not limited to, unmet needs & payer value story, working with an agency, learning the Promotional Review Board (PRB) process and usage of VEEVA, developing & testing value messages, generating Real World Evidence (RWE) to support the payer value proposition.
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review job Company: Lhh Recruitment Solutions in Princeton, NJ
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