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Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director. Reporting directly to the Senior Director CMC of Regulatory Affairs, the (Associate) Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions.
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Faculty contributions span various fields, including international law, foreign policy, security, economic relations, environmental policy, and gender analysis in international affairs. The Dean will play a key role in ensuring that the Fletcher School remains a prominent presence in international affairs education, research, and discourse.
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Previous experience or exposure to regulatory, government, or external affairs. And our Water Quality companies-Aquatic Informatics, ChemTreat, Hach, McCrometer, OTT HydroMet, Sea-Bird Scientific, Trojan Technologies, and XOS-help customers manage, treat, purify, and protect the global water supply, from municipal and wastewater treatment facilities to lakes, rivers, watersheds, and oceans.
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The applicant is expected to develop highly effective collaborations with relevant stakeholders including those in Patient Health & Impact, the Patient-Centered Outcomes Assessment Group, Statistics, Clinical Pharmacology, Clinical Development, Medical Affairs, Epidemiology, Programming, and other groups contributing to HEOR analysis and strategy.
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The impact you will make:Agios Pharmaceuticals is searching for a dynamic MSL/Sr. MSL (Medical Science Liaison) to join our growing Medical Affairs team. The MSL will conduct scientific exchange with KOLs in supporting Global Medical Affairs goals and objectives.
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In addition to the Master's in Law & Diplomacy (MALD) and Master's in Global Affairs (MGA), the Fletcher School also offers a Master's in International Law (LLM), a Master's in International Business (MIB), a Master's in Global Business Administration (GBA), a Global Master of Arts (GMAP), and a PhD.
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Serve as cross-functional strategic leader on all Medical and Clinical work streams in the oncology portfolio, including clinical pharmacology, statistics, clinical operations, regulatory affairs, and preclinical science and translational medicine.
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Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and GCP. Collaborate with Pharmacovigilance, Medical Affairs, CMC and applicable functional specialists to identify, evaluate and manage safety signals including input in Health Hazard Assessments.
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You’ll collaborate closely with product marketing, global digital, demand generation and scientific affairs to ensure our content strategy rolls up to overall marketing goals and supports cross-functional initiatives.
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Must maintain an excellent working relationship with SI's Office of International Affairs, U.S. Citizenship and Immigration Service, Department of Labor, Department of State, and the United States Information Agency (USIA.
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The Associate Director will work collaboratively with the Pre-Award Services office within the ORA, the Sponsored Programs Accounting office in Financial Affairs, the Deans of the academic units, Department Chairs, Directors of Centers and Institutes, the Division of Science Pre- and Post- Award teams, and other departmental liaisons with involvement in managing sponsored research at Brandeis to support Brandeis' core mission as a research institution.
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This role demands a collaborative leadership style, partnering with cross-functional teams across Medical Affairs, Global Market Access, Corporate Communications, R&D, Finance, and others to influence and execute a cohesive and impactful global strategy.
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Data Management and ReportingMaintains accuracy of ER event data and Leadership Society donor information in Harvard’s Alumni Affairs & Development database (Advance); reviews monthly data related to fundraising and engagement goals for Leadership Society and maintains donor lists and documentation in Advance.
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Initiate and lead the development of a cross-portfolio external engagement strategy and related tactics for prioritized external organizations and HCPs, aligned across Global Medical Affairs Oncology, Commercial, Patient Value, Policy & Access, R&D, Corporate Communications & Advocacy, Health Equity and Patient Affairs, and with other key cross-functional/ex-Oncology partners as needed to ensure a one company approach to external engagement strategy, objectives, and execution.
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We are seeking a (Sr.) IT Support Specialist / IT Administrator.to provide the following services. Deskside SupportDesktop hardware, OS, application management, Windows Defender ATP.Network troubleshooting, MDF/IDF Patch cabling, Cisco Meraki, coordinating with ISP for diagnosis and resolution.
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affairs job Title: sr regulatory affairs associate in Lexington, MA
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