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Utilizes software systems, including Medicat, PeopleSoft, a BASICS Feedback Survey tool, and Microsoft Outlook and Excel, to manage referrals to and from BASICS as well as scheduling and the online assessment students complete as part of BASICSCollaborates closely with colleagues across University Health Services and from across campus, including the Office of the Dean of Undergraduate Students and Graduate Student Affairs, to receive referrals and educate campus partners about BASICS.
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The CMC Regulatory Associate Director, Biologics is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support biologics products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
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Associate Director, Global Regulatory Affairs Operations, Authoring Support page is loaded. The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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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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The Associate Director, Regulatory Affairs – Advertising & Promotion will provide strategic regulatory advice on advertising and promotion for assigned products in accordance with business goals and objectives, FDA regulations and guidances, and company policies.
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This is done in alignment with the Global Medical Affairs and corporate strategy. The Senior Director of Medical Affairs in Oncology provides exceptional medical leadership for creating and implementing medical affairs strategies, plans, and tactics for the current products and pipeline portfolio in Oncology for the North American region.
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Interacts internally with team representatives from PCOR, Finance, Brands, Medical Affairs, HEOR, Commercial Pipeline, Field Sales, Account Management, Analytics, Investor Relations, Value Communication and Contracting Strategy colleagues across all franchises, and all others, including global colleagues/counterparts, on a routine basis.
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Must be able to effective articulate and negotiate complex project related matters to FDA. Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
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Support project teams, regulatory affairs, product management, marketing, and product stewardship in topics related to toxicology and kinetics. The position is located in Princeton, NJ and is part of the global Regulatory Affairs Toxicology Group.
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5-7 years of pharmaceutical and or life sciences marketing experience; additional pharmaceutical experience in sales, medical affairs, and market access a plus Experience with marketing and/or selling biologics within at least two of the following disease areas is REQUIRED : dermatology, immunology, rheumatology.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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Key Responsibilities: Collaborate with the head of NA HEOR and cross-functional teams, including members of medical affairs, clinical development, regulatory, market access, and commercial. SUN Pharma, Princeton, New Jersey (ONSITE: Hybrid 3 days in office; 2 days remote)Director, Health Economics & Outcomes Research Summary: Sun Pharmaceuticals, one renowned global specialty generic pharmaceutical manufacturer, is looking for a dynamic, experienced, and motivated professional to support the planning, design, and execution of HEOR and RWE generation programs.
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Background in community engagement, advocacy, public policy/affairs, and/or health and social equity. Master’s degree in public health, nutrition, exercise science, public policy, or public administration preferred.
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License to practice Speech Language Pathology issued by PA Bureau of Professional and Occupational Affairs is preferred. Will consider strong Clinical Fellowship Year (CFY) candidate for Long Term Substitute (LTS) positions in the Related Services program.
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Certificate of Clinical Competence in Speech-Language Pathology (CCC-SLP) is required* The Speech-Language Pathologist (SLP) will access needs, plan strategies and deliver evidence based supports to students with communicative disabilities across a variety of educational settings to include general and special education classrooms, specialized schools and community settings.
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affairs job Title: sr affairs associate in Lawrence, NJ
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