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The SSO Study Start-Up Team Lead is supporting the country/OPC SSU strategy and prioritization in close collaboration with SSU/OPC Head and Country/OPC LT to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). We assist companies and non-profit organizations in delivering benefits to their employees.
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Draft, review and negotiate agreements for the quality, regulatory and medical affairs departments, including but not limited to, quality agreements, clinical trial agreements, services agreements, material transfer agreements and research agreements.
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Fosters staff compliance with all regulatory requirements (OSHA, HIPAA, TJC, DOH, ADA, etc.) Collaborates with the unit leadership team to ensure competent staff performance to promote quality patient outcomes and meeting of regulatory guidelines.
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License to practice Speech Language Pathology issued by PA Bureau of Professional and Occupational Affairs is preferred. Will consider strong Clinical Fellowship Year (CFY) candidate for Long Term Substitute (LTS) positions in the Related Services program.
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Series 07 - FINRA, Series 63 - FINRA, Series 66 - FINRA. FINRA Series 7 & 63 licensed; Series 65 or 66 licensed and appropriate state registrations OR ability to acquire series 65/66 upon hire. We welcome those with experience in jobs such as Senior Accountant, Residential Real Estate Agent, and Billing, Cost, and Rate Clerk and others in the Accounting and Finance to apply.
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Frequent contact with client auditors and regulatory representatives (e.g. FDA, DEA) for inspections, questions related to validation matters as required by the Validation Manager. Provide support for customer audits and external regulatory audits specific to validation activity at all Sharp facilities at the direction of the Validation Manager.
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Certificate of Clinical Competence in Speech-Language Pathology (CCC-SLP) is required. The Speech-Language Pathologist (SLP) will access needs, plan strategies and deliver evidence based supports to students with communicative disabilities across a variety of educational settings to include general and special education classrooms, specialized schools and community settings.
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Job DescriptionThe Clinical Evaluation Manager reports directly to the Regional Lead, Clinical Evaluation Reporting, MSA. The individual creates CERs in support of EU-MDR regulatory approval strategies across the Endoscopic Solutions Division (ESD)/Therapeutic Solutions Division (TSD) and business unit portfolio and meet timelines acc.
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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide.
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The incumbent will also design, implement, and maintain data-driven analysis routines, metrics, and reporting activities, as directed, for the Governance, Risk, and Compliance’s (GRC) internal investigation’s function.
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Perform general maintenance and comply with regulatory and company policies and procedures. ABARTA Coca-Cola Beverages, LLC is an Equal Opportunity Employer. Operate industrial power equipment and a manual/powered pallet jack or lift product.
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We are searching for a Sr. Performance Analyst to join the team. You must be familiar with value-based care principles, particularly the intricacies of the Medicare Advantage (MA) Stars & HEDIS quality measures and the Medicare Shared Savings Program (MSSP), thrive in a quickly changing environment by bringing order to ambiguous situations, and deftly synthesize and connect different perspectives to drive critical projects forward.
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One or more years of experience with hospital admissions procedures and regulatory guidelines for admissions preferred. Helping patients regain hope and independence, Encompass Health is a national leader in post-acute care.
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The Executive Director of Advertising & Promotion- Regulatory Affairs prescription drug products manages and, if required participates in, the reviews and approvals of advertising and promotional labeling pieces for prescription drugs.
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regulatory affairs jobs Title: sr director Company: Merck in Center Valley, PA
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