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The Associate Provost for Student Affairs and Dean of Students (AP/Dean) provides strategic leadership for the MGH Institute of Health Professions in the areas of student services, admissions and other enrollment services, and overall student success.
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Manage Information Technology applications within Student Affairs, including StarRez (Housing), ARMS (Police), ARMS (Athletics), Campus Groups, ISSM, iModules (with Advancement), Medicat, Advocate (CARE), RAVE, and Titanium.
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Environmental Permitting: Assist clients in navigating the regulatory permitting process, including obtaining permits for activities such as air emissions, wastewater discharge, wetland impact, and hazardous waste management.
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Reporting to the VP of Program Strategy & Management, this person will work collaboratively to manage and integrate diverse R&D activities including but not limited to, preclinical research, clinical development, CMC, regulatory affairs, new product planning, business development and finance.
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This role works closely with key stakeholders including CMC, Supply Chain, Development, R&D, Clinical, Regulatory Affairs and Project Management to define the analytical capabilities required to effectively manage Dyne's complex clinical supply chain and support eventual launch and commercialization efforts.
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The Assistant Vice Chancellor for Academic Administration and Financial Services has primary responsibility in coordination with Administration and Finance, Human Resources and other central offices for the delivery of administrative and financial services to academic affairs units that fully and effectively facilitate attainment of the university's and individual college's educational and research goals and objectives.
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This includes providing solutions-oriented feedback and working collaboratively with other cross-functional team members, such as Medical Affairs, Marketing, Legal, and Regulatory. Support content development in Concept and/or Draft phases within the Medical Affairs and Commercial and teams, including MSL Training, MSL Content, Medical Directors, Scientific Communications, Medical Information, and Medical Training; including Medical Affairs project submission in Veeva Vault as needed.
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Collaborate with cross-functional teams, including analytical development, process development, quality assurance, and regulatory affairs, to ensure seamless project progression. Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
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You will collaborate with colleagues in other functions including Study Physician, Patient Safety, Regulatory Affairs, Clinical Operations, Translational, CMC, and early development groups.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
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Liaise with the Government Affairs, Regulatory Affairs, Origination and Community Impact teams at Reactivate's JV parents Invenergy and Lafayette Square to coordinate efforts and leverage a broader understanding of market and community dynamics.
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A vocal advocate for Harvard Griffin GSAS in student affairs spaces at the University, the Dean of Students is an integral part of the student-facing work undertaken by members of the Student Affairs teams.
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The Associate Director, Public Affairs will serve as a critical Policy & Advocacy team member with responsibility for relations and collaboration with City and State legislators and regulators who make legislative, regulatory policy, and public policy decisions.
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You will work alongside a small team of ~5-7 other lawyers/paralegals supporting regulatory, corporate, transactional, and procurement matters and closely cooperate with other departments to deliver holistic and streamlined legal support to the U.S. RWE Offshore Wind business.
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In this role, you will support and partner closely with the Company’s management team to support all functional groups, including research, development, manufacturing, alliance management, licensing and collaborations, intellectual property, regulatory affairs, human resources, finance, accounting, corporate governance, SEC filings and investor relations, business development and corporate development.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Pwc in Cambridge, MA
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