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Monitors and ensures compliance with worldwide regulations, safety reporting to RAs, Investigator/ECs, and Business Partners adhering to regulatory reporting timelines, workflow deliverables, and KPIs for DSPV (including generation of Compliance Reports for the respective activities.
$210,000 - $239,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Office of the General Counsel (OGC) for the Massachusetts Department of Public Health (DPH) is seeking a Chief Deputy General Counsel to lead the policy, programmatic, and litigation efforts within the OGC. As the Chief Deputy General Counsel, you will play a key role in managing, advising, and shaping legal strategies for multiple programs and regulatory matters, particularly focusing on the Bureau of Substance Addiction Services (BSAS.
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The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products. Provides CMC regulatory guidance to cross-functional teams and key stakeholders.
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8+ years of legal experience in a corporate environment or a law firm handling international commercial transactions, including experience with international business development, contracting and regulatory compliance matters, including ITAR, EAR, FCPA, and trade compliance regulations.
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At least 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity including at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
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Strong knowledge of pharmacokinetics and pharmacodynamics principles, immunogenicity, modelling and simulation, Model-Informed Drug Development, ADME Concepts, and regulatory clinical pharmacology requirements to support clinical development and regulatory submission.
$150Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Prior Authorization Specialist (PAS) is an essential role responsible for facilitating exceptional patient experience, by securing authorizations for all scheduled services related to medical and surgical admissions across entities, including BWH OR procedures, BWFH OR procedures, FXB OR procedures and BWH/BWFH Endoscopy Suite procedures in accordance with standards established by the Department, Hospital, Medical Staff, and outside regulatory and accreditation agencies.
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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.
$18.75 - $19.35 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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Oversee all regulatory (SEC/Finra, CFTC/NFA, FERC), ISO-specific and general business filing and reporting requirements, and have or obtain NFA Series 3 certification. The COO is also responsible for all trade support operations, trading risk management, regulatory and business compliance, and office operations.
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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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Demonstrated understanding of current global safety regulatory reporting requirements for investigational and marketed products. Provide strategic oversight for safety sections of all regulatory documents, including BLA/MAA/NDA, EU Risk Management Plans/REMS, PSUR/PBRERs, DSURs, ICFs, public presentations and key scientific articles and abstracts.
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Experience in engaging regulatory professionals for navigating the product development process through FDA regulatory submission, scaling manufacturing, and post market surveillance. This is an opportunity to join a dynamic team as an Engineer I, Medical Device at a venture backed Medical Device organization, reporting directly to the CTO. The successful candidate will drive key activities throughout the development phases of the combination product as well as transitioning the design to large-volume manufacturing, and facilitate the deliverables to support regulatory filing, product launch, and post market surveillance.
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Under the direction of the Director of Appeals and Grievances, this clinician will ensure clinical/pharmacy appeal cases reviews meet contractual, regulatory and business goals. Maintain compliance with all regulatory and NCQA requirements with regards to this important work.
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Counsel key stakeholders on legal, regulatory and policy developments such as Inflation Reduction Act, fraud and abuse, privacy, government price reporting and antitrust. Assist with a broad range of other healthcare regulatory matters including funding requests and client and vendor training.
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regulatory job Title: principal consultant Company: Parexel in Cambridge, MA
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