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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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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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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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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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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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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.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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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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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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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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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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Capital One is hiring a technical Cyber Security professional to join the Data Loss Prevention (DLP) team and work with the line of business stakeholders building DLP system policies/ruleset based on ongoing regulatory requirements and analysis of user business processes and workflows.
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Must have the ability to communicate positively to all LOL, customer, regulatory or vendor representatives as needed. Lead will work closely with the Maintenance Supervisor/Manager, Maintenance Planner/Scheduler, Mechanics and key production personnel.
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Maintain required documentation according to DDS, DMH, MassHealth, HUD, DPH, CARF, and all applicable regulatory standards as well as Bridgewell policies and procedures. Provide services to individuals according to DDS, DMH, MassHealth, HUD, DPH, CARF, and all applicable regulatory standards, as well as Bridgewell policies and procedures.
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The Cyber Information Assurance Specialist will define requirements for business continuity, operations security, cryptography, forensics, regulatory compliance, internal counterespionage (insider threat detection and mitigation), and physical security analysis (including facilities analysis and security management) to best protect company assets.
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regulatory job Title: sr regulatory affairs associate in Lexington, MA
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