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Establish regulatory reporting metrics and tracking mechanisms to maintain regulatory compliance. As the Senior Program Manager of Global Regulatory Reporting, you will manage and execute our global regulatory reporting program.
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Including but not limited to: Client Retention and Satisfaction, Financial Performance and Requirements, Regulatory Compliance, Purchasing Requirements, Culinary Programs and Standards, Human Resources Management, Retail and Marketing Programs.
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Pharmacy Technicians take important steps to ensure all medication needs and regulatory compliance standards are met for our patients and they demonstrate ethical conduct and maintain patient confidentiality at all times.
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Position Title: Senior Regulatory Affairs Specialist – RA/QA - Position location/Corporate Office in Malvern, PA. The Senior Regulatory Affairs Specialist is primarily responsible for leading and assisting with various regulatory submissions, authoring, and editing regulatory documentation and procedures, and participating in compliance activities.
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Proven expertise in integrating MES, Manufacturing Systems, PLM, LIMS, and SAP with a strong understanding of regulatory requirements (e.g., FDA, ISO). Collaborate with Computer Systems and Software Validation Engineer to ensure regulatory compliance and assess/identify risks.
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Organizes and prepares with Director of Education monthly All Staff meetings with the Vanguard School workforce to provide a platform for an exchange of ideas, expression of concerns and a review of relevant regulatory compliance and VFES policies and procedures as needed and deemed appropriate.
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The Regulatory Affairs Specialist (RA Specialist) is responsible for supporting registration of West’s Administration and Safety System devices, with primary responsibility for obtaining device regulatory approvals/clearances in the APAC regions.
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Coordinate all distribution needs including material ordering and removal requests; ensure Food and Drug Administration Office of Prescription Drug Promotion (OPDP) compliance submission to Incyte Regulatory Affairs.
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Oversee, manage and provide technical expertise on site investigation and remediation projects for a variety of clients with complex technical/regulatory issues in the chemical, manufacturing, oil and gas and other industrial sectors.
$174,795 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Drives the study start-up process in conjunction with the CRO ensuring timely submission of regulatory documents and completion of clinical trial agreements and budgets. Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical studies.
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The responsibilities for this role will consist of maintaining daily financial affairs, cash management, overseeing the monthly and quarterly close process, business development, preparing journal entries, assisting with sales and use tax activities, maintaining the general ledger, driving the accounting and finance team, monitoring internal controls, ensuring accurate financial reporting, and assisting with treasury and FP& A transactions as needed.
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The Corporate Sales Analyst II is accountable for serving as a sales specialist for all Chemical products, regarding long-term commercial and government contracts, involving a high level of complexity in customer specifications and regulatory requirements.
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Direct and provide on-going education support at the hospital level Compliance/Regulatory. Provide oversight of the audit process(s) to ensure regulatory compliance and consistency in approach.
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Adhere to standards set by government agencies and regulatory bodies (e.g., CLIA). ASCP Histotech Cert. 2 + years directly managing Laboratory Histology and /or Cytology operations. Are you a Pathology Lab Manager looking to join an established company where they actually want you to succeed and grow.
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Ensuring compliance with all federal, state, local, legal, regulatory and clinical standards and requirements including but not limited to HIPAA, OSHA, JCAHO, DOH, and CLIA. Provide leadership support and facilitate communication with representatives from the following broad areas: Nursing, clinical and physician hospital leadership specifically in the Department of Pediatrics, EPICcare, PARC and CHOPLink, PBRN and research investigators, additional hospital wide initiatives to the extent that they intersect with Primary Care (i.e.: Global Health, Homeless Health, Community and Government Relations, etc.
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regulatory affairs jobs Company: Vector Marketing in West Chester, PA
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