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May develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director.
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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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Help Sr Specialist manage IRB/EC and regulatory submission and approvals, including amendments and continuing reviews. The Clinical Trial Associate, SSU will aid in study start up activities for Fractyl's global clinical program, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals.
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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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Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents.
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The Prior Authorization Specialist (PAS) is an essential role responsible for facilitating exceptional patient experience, by securing authorizations for all scheduled services related to medical and surgical admissions across entities, including BWH OR procedures, BWFH OR procedures, FXB OR procedures and BWH/BWFH Endoscopy Suite procedures in accordance with standards established by the Department, Hospital, Medical Staff, and outside regulatory and accreditation agencies.
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Familiarity with regulatory requirements and compliance in equity capital markets. This is a brand-new role for the firm, reporting to our CO-Chief Investment Officer and will offer an exciting opportunity to become a pivotal partner in shaping our equity capital markets strategy.
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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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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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ImmunoGen is currently looking for a highly motivated team-player to join our Regulatory Affairs department. Execute CMC regulatory strategy for submissions (e.g. IND/CTA/BLA/MAA.
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Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions. We are recruiting a Scientist II/Sr. Scientist I with experience in phase-appropriate analytical method development, optimization, and qualification of physicochemical assays for lot release, stability, and characterization of cell and gene therapy products to support Beam's in vivo programs using lipid nanoparticle (LNP) delivery.
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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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Expertise in biochemical and bioassay techniques Proficient with lab software (LIMS, Empower, Bio-Rad Image Lab) Working knowledge of regulatory standards as they. Executes routine procedures based on biochemistry methodologies, such as HPLC, UPLC, SoloVPE.Execute routine procedures based on bioassay methodologies, such as plate-based assays (ELISA, ddPCR, ribogreen), gel electrophoresis, western blot and cell based assays.
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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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Moderna Infectious Disease Development is seeking a motivated and energetic Program Leader with a broad scientific skill base and deep expertise in infectious disease research and development to lead the Cytomegalovirus Vaccine Program Team. The Program Leader will lead a cross-functional team to develop and align stakeholders on the development and regulatory strategy and drive progression of the vaccine candidate through late-phase development, filing, approval, and lifecycle management.
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regulatory affairs jobs Title: sr regulatory affairs in Lexington, MA
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