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10+ years' experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We work on a wide variety of technologies including AWS, Oracle, Snowflake, Angular, Java, Spring Boot, Python, REST/API, Kafka, and Tableau.
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Significant in-house experience advising on data privacy, data protection and the legal and regulatory aspects of product development in the technology space (experience at a consumer-facing, Internet company preferred.
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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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We assist companies and non-profit organizations in delivering benefits to their employees. The Role : The Finance Internship is for candidates interested in analytical and back end of finance. Finance Internship Program.
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Understanding of regulatory requirements and frameworks such as HIPAA, PCI-DSS, and NIST. Security and Compliance: Ensure CyberArk implementations comply with internal security policies, standards, and regulatory requirements.
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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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The Employment Attorney will manage employment litigation and investigations related to whistleblower allegations arising under the Sarbanes-Oxley Act and Dodd-Frank Act, and other applicable federal/state laws, including claims of retaliation, fraud, and regulatory/compliance violations.
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A thorough understanding of global drug development functional areas including preclinical, clinical, regulatory affairs and manufacturing. Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS.
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The Finance Vice President will be responsible for managing all fiscal affairs of Tech Opportunities, including reporting activities, cash management, financing activities, risk management (including interest rate and currency hedging), budgeting and forecasting, and managing the day-to-day operations of the Finance team.
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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 are looking for a Sr. Regulatory Affairs (RA) Specialist who wants to grow your skills and take the lead on U.S. and international medical device submissions. Formal qualifications include B.Sc. or higher degree in science, medical/clinical, regulatory affairs, engineering or other relevant field and at least 5 years’ relevant experience from Regulatory Affairs with medical devices.
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The Medical Science Liaison (MSL) is a member of a field-based team of scientists who function as an extension of the US Medical Affairs organization. MSLs provide medical information through scientific exchange, and clinical/scientific support for Jazz Pharmaceuticals and the Medical Affairs department.
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As a pivotal leader within the Division of Student Affairs, the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large and multifaceted residential program.
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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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regulatory affairs jobs Title: assistant Company: Citi in Watertown, MA
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