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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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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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Providing guidance on FDA approval pathways and regulatory issues under relevant legislation. With a team of senior business lawyers with substantial in-house and general counsel experience, Outside GC provides private and public companies and non-profit organizations with outstanding corporate and IP legal services as needed at a fraction of the cost of either hiring a full-time general counsel or relying exclusively on law firm counsel.
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External Affairs consists of Communications, Government and Regulatory Affairs, Labor and Workforce Planning, and Community Engagement teams. Senior Regulatory Affairs Manager. Minimum of five years of public policy and regulatory or legislative experience.
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Collaborate externally with Drug Safety vendors and business partners on case management issues, processes, and timelines to meet global regulatory requirements for adverse event reporting and data exchange obligations.
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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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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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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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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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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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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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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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Is accountable for oversight of timely preparation and quality of Preclinical DMPK sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.) May be a point of contact for government regulatory agencies for their function.
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regulatory job Title: principal Company: Parexel in Boston, MA
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