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Reporting to the Vice President of Clinical Operations, the Trial Master File (TMF) Associate Director / Director serves a key role, working across the organization for the execution of TMF Operations processes and strategy.
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Provide timely and quality service to Tax Department stakeholders including Accounting, Finance, Legal, Sales, Procurement and HR (Human Resources). About the Role: If you are looking for a challenging role at a high growth technology company as a Global Income Tax Director, then this role is for you.
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This role is overseen by both the GIM population Health Manager as well as SCO Medical Director and SCO Clinical Director of Care Management. The Population Health Specialist for GIM-SCO Primary Care is responsible for providing prospective panel management for patients with Wellsense SCO (Senior Care Options) insurance and primary care based at GIM. The Population Health Specialist will provide direct patient outreach to promote patient engagement, care coordination and quality metric fulfillment.
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The Director, CMC QA will report to the Executive Director of CMC QA and be responsible for maintaining strategic responsibility over QA Operations, developing and implementing Ultragenyx CMC Quality approach for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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Fidelity's Asset Management Technology Division is seeking a Director of Quant Development to join their Fixed Income Embedded Quant Development Team. This is a core software engineering role in our dynamic and fast-paced quantitative development team.
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Scope of ResponsibilityWill serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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Supervise, orient, train, evaluate, and counsel department employees to improve their job performance and to maintain high standards of performance and patient quality care, in conjunction with the Regional Director of Operations and Human Resources.
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Minimum of 15 years professional working experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience with at least 5 years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections.
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Reporting to the Director of Corporate and Foundation Relations, the Assistant Director will lead high-level stewardship to current donors through quality written reports and related communications; identify and evaluate potential new funding prospects; support faculty with drafting LOIs, concept papers, and other solicitation materials; and lead administrative work for the CFR office, including special projects such as website design.
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Collaborate with development team in building innovative, event driven, API-first cloud native solutions using AWS platform, Snowflake, Snaplogic, Tableau, Python and Rest APIs iteratively deliver high quality products to enable our investment business, operations, analytics, and Client reporting.
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The Director, Assay Development, leads the development of new NGS- and protein-based assays in collaboration with a cross-functional team. Partner collaboratively with the Regulatory Affairs, Computational Biology, and Quality Assurance Teams across the enterprise to ensure that all procedural and submission documentation meets audit, compliance, and accreditation standards.
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Experience in accreditation process and maintenance, such as APA, AAAHC, JCAHO, or IACS. Supervision Received:The Clinical Social Worker works under the general clinical and administrative supervision of the University Health Services Director of Counseling Center and practices within departmental policies, individual privileging and credentialing and licensing procedures.
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Role Overview: As the Apheresis Quality Specialist, you'll collaborate closely with our Medical Director and enterprise Pathology Quality leadership to develop, revise, and maintain our unit's quality management plan.
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Under the general supervision of the Anesthesia Tech Supervisors (day and/or evening/night) and oversight from the Medical Director at Brigham and Women’s Hospital (BWH), and following established procedures, assures the quality of service and monitoring patients undergoing anesthesia in all anesthetizing locations throughout the hospital.
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