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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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Skilled in writing and supporting the generation of regulatory documents related to Bioanalytical package (e.g. briefing book, assay description, CTD modules for IND/MAA etc) and regulatory interactions (e.g. with FDA CDRH, EU notified bodies.
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The ideal candidate will have a solid understanding of Anti-Money Laundering (AML) and Bank Secrecy Act (BSA) laws; regulatory consent order action plans and artifact validation; risk and control matrices; and design/operational effectiveness testing.
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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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We are accountable for enabling our programs in early research to reach development candidate nomination through regulatory filing and into clinical trials. How you will Achieve More with Intellia:Intellia is look for a Director, Genotoxicity Regulatory Lead to support the advancement of genome editing products into the clinic.
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The person will work directly with stakeholders across – ESG Investments, ESG Product Strategy, ESG Data and Operations, Client, Product and Regulatory Reporting, and Enterprise Risk Management to understand their data and reporting requirements and to translate requirements into functional specifications for technology partners building/ enhancing IT solutions for ESG reporting.
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Compliance and Regulatory Oversight: In collaboration with organizational risk management and compliance leadership, ensures compliance with all federal, state, and local regulations governing FQHC operations, including HRSA, DPH, CMS, HIPAA, and NCQA PCMH requirements and standards.
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Strong knowledge of and/or experience with government programs regulatory, operational, financial, and clinical requirements for the delivery of health insurance and managed care products and services, including Medicare, Medicaid, MMP, LTSS, SNP, Duals, CHIP, and behavioral health, as well as the associated and relevant federal, state, and local regulatory entities.
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We're currently seeking a strong Regulatory Affairs Specialist, (RAS) who will work to ensure that company products and processes comply with all applicable regulations and standards. Bachelor’s or equivalent in Regulatory Affairs or related Science, along with 5+ years' experience in a related industry.
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The Scientific Editor's responsibilities will be:Collaborate with scientists on nonclinical regulatory documents such as Investigator Brochures, Nonclinical Study Reports, Annual Reports, CTAs, INDs, and NDAs. Assume lead scientific writing responsibility on projects, utilizing regulatory and publication documentation expertise.
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Under the direction of the Hospital Coding Manager or Supervisor, and exercising independent judgment within the scope of the job, the Hospital Inpatient Coder II assigns applicable ICD-10 Codes, Present on Admission (POA), Hospital Acquired Condition (HAC), and Patient Safety Indicators (PSI) using current industry standards, the Official Coding Guidelines, Coding Clinic, UHDDS and regulatory requirements.
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Demonstrates compliance with regulatory requirements i.e. MIPS, fall assessment. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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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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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 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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regulatory job Company: Bluepipes in Boston, MA
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