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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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Act as a liaison between cross-functional teams, including clinical operations, regulatory affairs, finance, and business development, fostering strong communication and collaboration throughout the contract lifecycle.
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Within SBS, the DA will work directly with the Department Chair, Associate Chair, Associate Director of Finance, Assistant Director of Operations and Finance and the Assistant Director of Academic Affairs.
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The Program Manager, Clinical Regulatory Compliance & Accreditation works directly with staff, management, and senior leadership to coordinate and perform day-to-day activities related to regulatory compliance across all Dana-Farber sites.
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Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs.
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Under the general direction of the MassHealth Chief Medical Officer, or designee, the Program Manager for MassHealth Health Equity Programs works directly with MassHealth Program and Office of Clinical Affairs leadership to manage health equity measurement and value-based care initiatives for MassHealth programs.
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Preferred Qualifications Experience working with legal counsel on regulatory and legislative affairs. The Virtual Power Plant Policy Director will lead SUN’s policy, regulatory, and advocacy efforts to implement solar + batteries Virtual Power Plant (VPP) policy across the country and in targeted states.
$80,000 - $90,000RemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Preferred Qualifications: Knowledge of: Support services network, including programs and services offered by the Executive Office of Elder Affairs, Massachusetts Rehabilitation Commission, Department of Mental Health, Department of Developmental Services, MassHealth, Home and Community Based Waiver programs, and other Health and Human Service organizations.
$73,566.74 - $107,580.72 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems. Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems.
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The Director will report to PPLM’s Chief External Affairs Officer and will work closely with the Vice President of Research and Clinical Training; the Vice President of Education, Learning & Engagement; and the Director of Social Science Research.
$90,000 - $110,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Collaborate closely with other departments such as clinical operations, technical operations/CMC, translational research and regulatory affairs to ensure alignment on program objectives. Contribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents, ensuring they are conducted in compliance with regulatory standards and ethical guidelines.
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Requirements: 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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Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements. Open to Medical Lab Technician [2 year MLT degree ] or Medical Lab Scientist / MedicalTechnologist [4 year BS.
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Collaborate with the regulatory team to prepare and submit regulatory documents to health authorities, including INDs, NDAs, and BLAs. Collaborate with study team to prepare and complete clinical study reports, investigator's brochures.
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Certified Anti-Money Laundering Specialist (CAMS), Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Regulatory Compliance Manager (CRCM), or Certified Fraud Examiner (CFE.
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regulatory affairs jobs Title: principal consultant in Waltham, MA
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