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Support development of CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks. Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls.
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The Assistant District Attorney represents the Commonwealth in accordance with the District Attorney’s statutory authority in the various courts in Plymouth County, the Supreme Judicial Court, the Supreme Judicial Court for Suffolk County, the Appeals Court, and at times courts in other counties.
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Working closely with colleagues, office staff, victim witness advocates, law enforcement officers, court personnel, criminal justice agencies, community partners, and the public to ensure an ethical, effective, fair, and and professional approach to prosecution on behalf of victims and the communities we serve.
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The Senior Auditor will lead and/or participate on complex audits of Treasury, Accounting and Corporate Finance in areas including the Capital Adequacy Process, Liquidity Risk Management, Treasury Operations, Treasury Investment Portfolio, SEC Financial Statement Reporting, and Regulatory Reporting.
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Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs.
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Works closely and builds effective working relationships with accreditation and regulatory agencies, i.e., The Joint Commission, DPH, DMH and CMS. Responsible for all aspects of the plan to ensure continual readiness with the clinical regulatory and accreditation requirements of the TJC, DPH, DMH and CMS.
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Provides CMC regulatory guidance to. Provide guidance for regulatory CMC aspects of product development projects. collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications in alignment with the regulatory CMC strategy.
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Through your regular interactions with external stakeholders, energy efficiency contractors, engineers, and internal teammates including marketing and regulatory compliance, your will accomplish residential sector energy saving goals and help lower the state’s carbon emissions.
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Develop, review, revise and monitor policies and procedures to ensure that all work of the Appeals and Grievances Department meets all regulatory and accrediting standards. The Director is responsible for all aspects of the member appeals and grievance processes for all lines of business across the enterprise, including Commercial, Senior Products, Public Plans, joint ventures, and other state sponsored products.
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You will actively contribute to the continuous improvement of the informatics product and other software quality issues within our Point of Care portfolio by working closely with cross-functional teams in Research & Development, Supply Chain Management and Regulatory Affairs to identify and implement product improvements.
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A thorough understanding of the drug development process from pre-IND through registration and post-registration and a broad understanding of functional areas of drug development, including (preclinical, regulatory, pharmacology, translational medicine, pharmacovigilance, data sciences (data management, biostatistics, programming), and clinical operations is require.
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The QC Analyst II/III performs a wide variety of advanced activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results. Technical contributor on cross-functional projects related to all Cell Culture activities and Bioassay development.
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Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks. Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions.
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Installs repairs and maintains signs such as regulatory, historic and information signs by performing such tasks as digging holes and installing supports using a variety of hand or hand held power tools.
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Support the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports (DSURs) and periodic updates, and clinical sections of regulatory submissions to support product approvals.
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