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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Broad experience in US and Global Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Collaborate with regulatory affairs to support regulatory submissions and inspections.
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Knowledge of FINRA's regulatory operations, including the disciplinary process, examination programs, and overall functions and mission. With respect to the CWP Rules, collaborates with the Office of General Counsel to coordinate regulatory policy and develop rules and guidance including the preparation of regulatory notices, SEC filings, briefing materials for committees, and items for the FINRA Board.
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MedPro is one of the largest recruiters of therapists and nurses from outside the U.S. MedPro currently has contracts with numerous organizations to service a multitude of facilities in the U.S. The company counts among its clients prominent healthcare facilities and organizations such as the Department of Veterans Affairs,HCA, University of Miami Hospital, and Tenet Healthcare.
$3,006.98 a weekFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In-depth knowledge of value-based care models, healthcare reimbursement methodologies, and regulatory requirements (e.g., MACRA, MIPS, ACOs). Monitor and analyze actuarial data to ensure alignment with population health objectives and regulatory requirements.
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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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InteractionLeads engagement with internal key stakeholders (e.g. Global Medical Affairs, MCE, Region/LOCs, MPD, Global Outcomes Research and Epidemiology [GEO], and Publications) as needed. Description Objectives: The Associate Director, Global Scientific Communications, Mature Brands, is a dynamic, strategic role within Global Medical Affairs that collaborates with cross-functional partners to own one or more disease areas / assets on a Global level.
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Is knowledgeable regarding requirements for documentation, data submission, quality assurance and other reporting of UNOS, NEOB, CMS and other regulatory bodies and ensures compliance with Policy and Procedure for Data Submission to the OPTN. - Participate on committees and task forces that relate to organ transplantation.
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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package ( briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions ( with FDA CDRH, EU notified bodies.
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Collaborate with key stakeholders across the organization, including clinical operations, regulatory affairs, data management, and IT, to assess user needs, gather requirements, and develop tailored solutions to address business challenges.
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The Learning Systems Designer ensures that the Mission, Vision, and Core Values of Dana-Farber Cancer Institute (DFCI) and Nursing and Patient Care Services, as well as regulatory standards, are met.
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Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data-extraction, and IRB/regulatory requirements.
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Founded in 1906, the University is comprised of four esteemed schools-the College of Arts and Sciences, Suffolk University Law School, School of Public Affairs and Global Engagement and the Sawyer Business School.
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regulatory affairs jobs Title: principal consultant Company: Parexel in Waltham, MA
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