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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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The Director will chair the respective neurology TA Global Publications Team as well as engage with cross-functional partners including but not limited to research, clinical development, marketing, market access, medical affairs, regulatory affairs and biostats.
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Under the direction of the Senior Director, Accreditation & Regulatory and working collaboratively, the Accreditation and Regulatory Specialist (Nurse) leads efforts to ensure continual organizational compliance and ongoing readiness with clinical quality and patient safety standards and regulations required by The Joint Commission, Massachusetts Department of Public Health and Center for Medicare and Medicaid Services.
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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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Initiates and/or completes regulatory and other forms, such as MassHealth Long-Term Care and DMH/DDS PASSR forms and processes the completed forms with the appropriate agencies. Assesses, via electronic systems, patient’s insurance plans and benefits, such as MassHealth eligibility and Medicare benefits and facilitates coordination with Patient Financial ServicesPrepares, explains to patients, and documents delivery of the Medicare Important Message and Medicare Outpatient Observation Notice.
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Supervise and support reporting units, including Communications, Legislative Affairs, Constituent Services, Hiring and Staffing (Human Resources Liaison office), Federal Policy, Member Engagement, Housing and Homelessness Policy, and MassHealth’s Project Management Office.
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Leads nonclinical submission working groups to liaise effectively with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory, Regulatory Operations, Drug Discovery Units, DMPK&M, and Drug Safety Research and Evaluation) to recognize aims, align on strategy, define executable timelines, and agree upon content for nonclinical regulatory submissions.
$234,300 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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7 NorthThe Clinical Leader participates in planning, organizing, implementing and evaluating patient care and developing programs to support clinical care consistent with the mission and goals of Brigham & Women’s Faulkner Hospital as well as the requirements of JCAHO and other applicable federal, state and local regulatory and/or accrediting agencies.
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Primary Responsibilities:Provide support to Director in all aspects of EHS regulatory responsibilities for the University in compliance with Suffolk University policy, and Federal, State and Local applicable laws, regulations, and legal precedence as mandated by Federal, State, and other governing agencies including but not limited to EPA, OSHA, DEP, MWRA, DPH, NFPA, and DOT.Participates in the development and management of environmental, health and safety policies and procedures.
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Willingness to participate in professional associations involving hospital and school security and safety, including the American Society for Industrial Security (ASIS), the International Association for Healthcare Security and Safety (IAHSS) and International Association of College Law Enforcement Administrators (IACLEA.
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Manages the DFCI Biosafety Communications Program by identifying topics relevant to investigators with biosafety protocols such as upcoming modifications to IRIS for human gene therapy clinical trials and iRIS-IBC for laboratory registrations and any regulatory and DFCI policy updates, training requirements, resources and guidance, and those requested by the Director of Biosafety.
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Preferred Qualifications:CPR/First Aid /AED certification, along with other licenses and certifications prescribed by the Director of Public Safety/Chief of Police or his/her designee;Campus Public Safety experience and APCO Emergency Medical Dispatcher (EMD) and Public Safety Telecommunicator (PST) or other Public Safety/Law Enforcement dispatch training is desirable.
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Knowledge of CFTC & NFA swap regulations is preferred to enhance the compliance program and assist the swap dealer to satisfy its regulatory obligations. Assisting in responding to regulatory inquiries, audits, examinations and investigations, and liaising with regulators (CFTC & NFA.
$132,500 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
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This position is also responsible for verifying patient insurance, confirming benefits eligibility, performing pre-authorization, pre-certification, and/or notification as required by third party providers.
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regulatory affairs patient safety jobs in Boston, AL, Nebraska
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