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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) 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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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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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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The primary function of the Associate Director/Director of Biologics CMC Regulatory Affairs is leading the development and implementation of biologics CMC global regulatory strategies for FDA, USDA and other agency regulated programs in development and registration preparation for biologics animal health pipeline programs.
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Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements. Responsibilities are interchangeable within job titles of medical laboratory scientist (MLS), medical technologist or clinical laboratory scientist.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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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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The Financial Planning & Analysis Consultant is a member of the Treasury organization which is a dynamic team of individuals with diverse backgrounds that are focused on maintaining a balance between high and sustainable returns for policyholders, and a strong capital position, while enabling MassMutual to take advantage of growth opportunities; within internal, regulatory, and rating agency constraints.
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Preferred knowledge in thermal analysis, X-ray powder diffraction, contributions to synthetic chemistry, and regulatory documentation. Proficient in organic chemistry tools (HPLC, LCMS, GC, NMR) and software (ChemDraw, Excel.
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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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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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Responsible for psychosocial assessment s and intervention s in crisis situations that often involve issues of suicide, homicide, family violence, elder or child abuse. Licensed Clinical Social Worker (LCSW.
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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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In this collaborative role, you will be responsible for the research and development of AML procedures, regulatory engagement, and issue management related to our AML/KYC program, making a significant impact as our business continues to grow.
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Maintain a safe work environment and wear appropriate personal protective equipment Requirements: Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements.
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regulatory job Company: Abbvie in Watertown, MA
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