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Prepare/review technical documents including development/tech transfer reports and CMC regulatory submissions - Participate on cross-functional teams to progress both early and late stage drug candidates.
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This role will be responsible for implementing and managing the site Quality Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to global regulations and BMS policies and procedures.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO’s, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
$107,659 - $207,763 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Knowledge of FINRA, SEC and other regulatory rules and regulations. Assist with regulatory inquires and exams, including document and data retrieval. Compliance Ops Associate - FINRA Series 24.
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On-Board Scientific is hiring a Nonclinical Regulatory Document and Scientific Writer based out of either New Brunswick, Lawrenceville or Summit, NJ! Qualifications: At minimum, a Bachelor’s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs. + years of Regulatory drug development experience Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
$57.78 - $62.5Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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Conducts independent examinations, reviews, and related financial investigations of the most sensitive, complex or high profile cases encompassing all types of financial institutions (FIs) and non-financial trades or businesses (NFTBs) to assure their compliance with statutory and regulatory requirements of Title 31 Bank Secrecy Act (BSA), and Form 8300 filing.
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The Vendor Risk Management Specialist is responsible for supporting Vendor Management's First Line of Defense and Contract Owners / Relationship Managers during vendor due diligence and ongoing monitoring to ensure policy requirements are complete and meet company standards and applicable regulatory requirements.
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Collaborate with clinical and non-clinical departments to enhance patient-centered care and improve patient satisfaction value-based care goals, regulatory compliance ratings, and recognitions.
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The Senior Principal Scientist will collaborate across BMS sites with functional Analytical Leads, Drug Substance and Drug Product Leads, Quality Lead, and Regulatory Lead to generate and execute analytical strategies for the product quality.
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The Director, Model Validation for auto origination and pricing, will be responsible for conducting independent validation of models used for auto origination and pricing, with regulatory guidance on model risk SR11-07 and other regulatory requirements.
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They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions.
$32 - $99 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Study Strategy: Clinical study leader (CSL) or major scientific/medical contributor; For large or complex Phase 2 studies: Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, develops biomarker strategy in collaboration with TMCP, collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicable.
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Maintains knowledge of Federal, State, and other regulatory agency rules and regulations including The Joint Commission, CMS, Medicare, including but not limited to, knowledge of CMS rules regarding Observation status, the 2 Midnight Rule, and Medicare Inpatient Only Procedures.
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regulatory job in Morristown, NJ
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