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Demonstrated experience supporting regulatory and commercialization teams including providing legal counsel on Medical, Legal, Regulatory review committee, development and implementation of promotional activities, market access communications, drug labeling, scientific exchange.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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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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Leads the global Clinical, Pharmacovigilance, and Medical Quality Compliance organization, providing quality oversight of the quality systems supporting Takeda’s clinical research (GCP), pharmacovigilance (GVP) and medical activities across the enterprise and ensuring that it’s robust, aligned with and compliant to applicable regulatory requirements, and governed and positioned for continual improvement.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Ensure compliance with FDA regulations and ICH guidelines to meet all regulatory drug safety and pharmacovigilance reporting requirements. This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
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Accompany Public Health Department / Regulatory Inspectors during on-site inspections and respond to regulatory non-compliance and to the best of ability - mitigate or limit any future inspection violations.
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The Senior Regulatory Affairs Manager will also serve as the LRAC subject matter expert for all project implementation work associated with the assigned portfolio of regulations. The Senior Regulatory Affairs Manager is a key member of the Legal, Regulatory Affairs & Compliance (LRAC) team.
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Oversees safety vendor for all safety and PV operational activities and provides oversight of the ARGUS Global Safety Database implementation and updates through the safety vendor. In collaboration with Regulatory Affairs, provide information to be submitted to Regulatory Authorities and ensure timely submission of expedited safety reports.
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The Technology Manager will provide ongoing implementation and review of all technological systems to meet the clinical service delivery and regulatory compliance needs of a PACE model program including the integration of telehealth into all aspects of electronic health record (EHR) software system.
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Strong experience with the contents and implementation of specific regulatory initiatives such as: Dodd-Frank, general consumer compliance, regulatory structure and organizations including the FRB, the CFPB, the OCC, the CFTC, FINRA, and the SEC.
$167,325 - $306,763 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Assist in advising clients on improving their securitization process to meet monthly and yearly securitization contractual requirements, regulatory reporting requirements and trigger compliance monitoring of their securitization programs.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Lead cGMP manufacturing of TScan cell therapy products while adhering to cGMPs, SOPs, compliance/regulatory mandates, safety procedures, and quality requirements. Utilizes manufacturing knowledge to improve process operations and assists the identification and implementation of continuous improvement opportunities.
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Interacting effectively and collaboratively with therapeutic area Medical Affairs teams, Medical Communications, Compliance, Legal, Regulatory, and other MRC stakeholders. Collaborate with therapeutic area US Medical Affairs teams, Regulatory, Legal, Compliance, and Medical Communications to ensure best practices, long-term planning, quality, and compliance with policies and standard operating procedures (SOPs.
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Monitors and disseminates pertinent new laws and regulations as they pertain to privacy compliance matters, leveraging resources to ensure implementation for privacy compliance. Minimum of eight (8) years progressive management experience in health care operations, health information management, regulatory compliance, risk management, law, or similar field required.
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Works within legal, regulatory, accreditation and ethical practice standards relevant to the position and as established by BWH/Partners; follows safe practices required for the position; complies with appropriate BWH and Partners policies and procedures; fulfills any training required by BWH and/or Partners, as appropriate; brings potential matters of non-compliance to the attention of the supervisor or other appropriate hospital staff.
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regulatory compliance implementation jobs in Boston, MA
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