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With funding for the next 2 years, they are now seeking an exceptional physician leader to serve as Chief Medical Officer and build out their full R&D function including clinical development, clinical operations, regulatory affairs, biometrics, medical affairs and drug safety.
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This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs. Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred.
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company. Importantly, the chosen candidate will manage and mentor a group of Regulatory Affairs strategists.
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In this role, you will lead the legal support, including directly advising, educating BMS colleagues, staying current on evolving global regulatory, legal and policy environment for BMS’ work with digital solutions, including regulated patient and physician-facing digital health solutions (e.g., digital medicine and digital therapeutics) such as mobile applications, diagnostic algorithms, digital biomarkers, use of artificial intelligence and clinical decision support solutions.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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The sections are: Community Affairs, State & Elections, Consumer Affairs Counseling, Education and Higher Education, Employment Counseling and Labor, Health and Human Services, and Law & Public Safety.
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The *Internal Audit Control Manager *– Compliance Subject Matter expert is primarily accountable for ensuring adequate and appropriate audit coverage of federal/state/GSE requirements applicable to the organization by maintaining the compliance matrix and providing input to the audit plan and advice to audit teams regarding consumer compliance regulatory applicability.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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10+ years of past relevant experience in the power and/or industrial sector as a project manager. Project teams in our Energy & Industrial Group (EIG) support industry-leading projects in power generation, plant design, environmental compliance, mid/downstream oil & gas, and multi-disciplined industrial projects.
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VEOLIA is immediately hiring an experienced Sr. Project Manager-Wastewater to join our Haworth, NJ team! As a Senior Project Manager (or Engineer) of Wastewater with Veolia, you will play a key role in the planning and execution of projects for Water and Wastewater Utilities, including sources of supply, treatment plants, pumping stations and transmission mains and collection systems.
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The senior manager is responsible for the development of external integrated communication and public affairs (C&PA) strategies to support our Pulmonary Hypertension portfolio of products, primarily UPTRAVI, OPSUMIT, and OPSYNVI, as well as developing relevant content about diagnostics and treatment persistency to help bring awareness to this rare disease.
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Job SummaryThe Food, Safety, Quality, and Regulatory Manager is responsible for managing all FSQR activities and programs at the site level. In the U.S. or Canadian sites shipping to the U.S., act as Preventive Controls Qualified Individual (PCQI) and ensure all requirements are met for PCs/CCPs/oPRPs for FSMA and/or SFCR.Ensure compliance with specifications, customer, and regulatory requirements at the site.
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Assist the Clinical Program Director, Program Supervisor and Lead Housing Specialist in communicating with the Department of Community Affairs and HUD with Project Managers for COC vouchers for chronically homeless individuals in Mercer County.
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Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA, HIPAA, HCFA, DPW, LCGME, SCGME, etc) CCA CSAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD results, under the direction of the provider/orders and documents in EMR.
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regulatory affairs jobs Title: regulatory project manager in Trenton, NJ
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