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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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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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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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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.
$90,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Strong business acumen and ability to see the business drivers outside of Regulatory Affairs. At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
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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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Following the Ph. D., 2+ years of mathematical modeling & computer simulation experience in the pharmaceutical industry for the Sr. Research Investigator level or 5+ years for the Associate Director level.
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The Director, Corporate Counsel – Rare Disease will serve as the legal advisor to the US Commercial, Patient Advocacy, Public Affairs, Regulatory, and Medical Affairs teams supporting our Rare Disease Franchise, and will coordinate legal services with the attorney responsible for Canadian support for the Rare Disease Franchise.
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affairs job Title: sr affairs associate Company: Thermo Fisher Scientific in Princeton, NJ
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