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The Regional Medical Scientific Director (Medical Science Liaison) is a credentialed (i.e., PhD, PharmD, DNP, MD) Director Level Medical Affairs position and therapeutic and disease expert who engages in bidirectional exchange of scientific or medical information with Scientific Leaders (SLs.
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This will be accomplished by working in close collaboration with colleagues in Commercial, Regulatory, Market Access, Clinical Development, Corporate Affairs, Patient Advocacy and other key cross functional areas.
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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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Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations. The Director, Regulatory Affairs integrates and applies knowledge of US regulatory guidelines and federal regulations governing pharmaceutical drug development to all aspects of Our Client’s ’s drug development programs, policies and procedures; ensuring a compliant state of regulatory commitment.
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Expertise in R&D functions (e.g., Clinical Operations, CMC, Regulatory, Project management, Commercial) preferred. The Associate Director, Portfolio Management Insights, Portfolio & Strategic Operations (P&SO), drives portfolio management insights development and delivery to the Global Program Teams (GPTs), Therapeutics Areas (TAs) leaders, Hematology Oncology Cell Therapy (HOCT)/Immunology Cardiovascular Neuroscience (ICN) leadership, crucial for strategic decision-making within the drug development portfolio.
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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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Minimum of 10 years of experience in regulatory affairs, with at least 5 years in advertising and promotion compliance. The Director, Regulatory Advertising & Promotion is responsible for ensuring that all promotional materials and activities comply with the applicable laws, regulations, and guidelines in the US. You will be responsible for the review of promotional materials, providing strategic guidance to the commercial teams, and interacting with FDA's OPDP on advertising and promotion matters.
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Perform and coordinate project work involving site investigation, utility location and clearance, risk assessment and remediation of soil, groundwater, and sediments with moderate to complex technical/regulatory issues with manufacturing, power, chemical, oil & gas, and technology sector clients.
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Continue to improve the overall operation of the NJ BAS including implementing new technologies, optimizing processes, timely SOP revision and addition to meet high quality bioanalytical GLP facility requirements and assure regulatory compliance.
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In compliance with legal and regulatory requirements, the MSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen products.
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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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Also, interacts routinely with colleagues across Market Access and Public Affairs, including franchise teams, and internal stakeholders from PCOR, Finance, Brands, HEOR, Government Pricing. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the people who need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes.
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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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Associate Director , Statistical Programming , provide s functional expertise and leadership to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products.
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Drives WMT executive reporting, risk routines, analytics, and proactive insights across the risk portfolio (i.e. RISE compliance deliverables, Third Party Risk Management, regulatory/audit/issue management, infrastructure vulnerabilities, non-permitted technology, Global Information Security findings, and Disaster Recovery plans and continuity testing.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Gpac in Lawrence, NJ
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