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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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Key Responsibilities Manage GP models, review, parallel calcs, and analyze reporting of programs requiring price reporting, per legislative requirements, including Average Manufacturers Price (AMP), PHS Price, Best Price (BP), VA/FSS (Federal Supply Schedule), Average Sales Price (ASP), non-Federal Average Manufacturer Price (nFAMP), Federal Ceiling Price (FCP), Industrial Funding Fee (IFF) and Unit Rebate Amounts (URA.
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Conduct root cause, impact, and risk analysis for incidents in preparation for problem management review with product, legal, and compliance teams. Index products are available across multiple asset classes including equities, fixed income, FX, commodities, derivatives, and alternative investments.
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Position Summary / ObjectiveThe Senior Manager, GRS-CMC is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); &/or post-approval submissions.
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Assists the Senior Medical Director in developing agenda for and executing national advisory boards, assists with defining strategies to support medical education programs and reviews IME grant proposals, represents Medical Affairs in Promotional Review Board (PRB) activities including reviewing medical and scientific content of promotional materials, maintains KOL relationships and serves as a consultant for Marketing, FMA, SCOE, Market Access, Public Affairs, and Sales.
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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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Review of municipal subdivision and land development applications, traffic impact and circulation studies, zoning ordinances. Duties and Responsibilities include, but are not limited to: 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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GDM is responsible for clinical trial data acquisition, data management and review, and medical coding for trials across the BMS R&D portfolio. Establishing and running governance for ongoing review of portfolio health successful delivery of portfolio priorities.
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Oversee protocol development, amendments, and clinical trial data review, ensuring trials meet ethical and regulatory standards. Stay up-to-date on advancements in oncology research and emerging therapeutic modalities, incorporating novel insights into development strategies.
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Maintains trademark portfolio management databases, including data entry, docket review, and preparation of reports for attorneys and business units. Executes domestic and international trademark screening and searching online, and conducts initial review of search results, to determine availability and scope of potential rights.
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Certified Professional in Healthcare Quality (CPHQ) by the National Association for Healthcare Quality, or be Certified in Healthcare Quality and Management (HCQM) by the American Board of Quality Assurance and Utilization Review Physicians Preferred QualificationsProject management experience preferred.
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Work closely with CEO, COO and CFO to develop insightful KPI reports, dashboards, and other operational analyses for review and decision-making. Prepare monthly, quarterly and year-end reporting including detailed general ledger, balance sheet and income statement for CFO and CEO review.
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Review and ensure, proper accounting of non-routine transaction with the support of GFRT in compliance with IFRS, IND AS and Global accounting policies. Periodic review and update the SOX controls for NAG and coordinate with SOX auditors.
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Documentation and Specifications: Prepare and review specifications, Standard Test Procedures (STPs), Technical Data Sheets (TDS), validation protocols, reports, and Standard Operating Procedures (SOPs.
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Analyze Global Safety Peer Review results and develop and implement solutions to eliminate exposure to these risks and prevent injury at other FCs. Analyze WHS metrics and review incident weekly and monthly incident trends to discover trends to justify the allocation of appropriate resources to areas where the safety risk is highest.
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review job Company: Boyle Shaughnessy Campo P C in Princeton, NJ
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