Serve as head for all regulatory activities for US products and to lead, manage and submit regulatory submissions to FDA to include supplements and post-approval reporting of marketed products
This role requires deep expertise in regulatory compliance related to private equity, real estate ... Develop and maintain reporting systems to track compliance metrics and provide regular updates to ...
Author, edit, and maintain a wide range of documents, including Standard Operating Procedures (SOPs), batch records, validation protocols, technical reports, change control documents, and regulatory ...
... reports * Coordinating mock audits and performing other related tasks as needed * File maintenance in accordance with federal regulations Responsibilities will include m anaging the daily ...
... and other regulatory agencies. Participates in patient teaching and discharge planning ... The Registered Nurse is responsible for reporting identified safety issues such as hazardous ...
... regulations/guidance related to ICD-10 coding and quality documentation and reporting • Interface with operations and clinical leadership to assist in identification of coding & documentation ...
Prior experience managing direct reports * Demonstrated knowledge of ICH GCP * Regulatory inspection experience a plus * Strong understanding/experience in rare disease patient recruitment and site ...
AML & Financial Crimes Compliance : Assist in the monitoring and reporting of potential financial crimes, ensuring adherence to regulatory compliance requirements. * Sanctions Monitoring : Evaluate ...
... and regulatory standards. An outstanding payroll specialist should also have excellent people ... Preparing financial reports for accounting and auditing purposes. * Preparing periodic payroll ...
... and report patient status, changes, and treatment outcomes in accordance with organizational and regulatory guidelines Benefits: Healthcare coverage: Medical, Dental, Vision 401K Paid Time Off ...
Prepare statistical reports, extract data for analysis, and support global safety reviews. * Ensure compliance with company policies and regulatory standards. Qualifications: * Bachelor's or Master ...
Document and report patient progress in compliance with healthcare regulations (e.g., HIPAA ). * Complete necessary reports and update care teams on patient progress, challenges, and success
... regulations. * Customs Coordination: Collaborate with customs authorities to facilitate timely ... Performance Reporting: Prepare and analyze reports to assess shipment performance and identify ...
This position reports to the Director of Law (General Counsel) and is responsible for assisting in ... Monitor NJTA staff compliance with all applicable laws and regulations and remain current on ...
Responsible for the quality programs and the adherence to all regulatory standards. The successful ... reporting of test results. Provides direct supervision when high complex testing is performed by ...
... quality and regulatory guidelines and policies are followed to develop safe and effective ... Create formal Verification test protocols, run tests, and write Verification test reports
... reports, clinical sample analysis reports and publications summarizing data, and writing/updating ... regulatory affairs on the implementation of these assays in clinical trials. Qualifications
... regulations. * Safeguard confidential and sensitive information. General Office Duties * Order office supplies and handle administrative tasks, such as invoicing and expense reporting for the legal ...
Is knowledgeable about EMTALA regulations and reporting of child/adult abuse to appropriate agencies and Hospital Social Worker. Maintains patient privacy and confidentiality. Qualifications ...
Acts as the OMIG Compliance Officer for Medicaid, overseeing regulatory compliance and audit ... Prepares comprehensive reports on revenue cycle performance, trends, and forecasts to support ...
The Supply Chain Manager reports directly to the Director of Operations of the site and works ... Training of specific country regulations a plus. 8+ years' experience with Medical Devices in ...
... regulatory changes * Managing the day-to-day Fixed Income Ops workflow, primarily covering ... report transactions * Researching and reconciling breaks, fails, open items, unencumbered ...
Coordinate with direct reports and communicate with management to establish action plans to drive ... Knowledge of regulatory and safety requirements related to distribution center operations
Perform daily task in accordance with all Safety regulations and protocols. Completes all safety ... Proactively report and follow up on potential unsafe conditions and suggest effective solutions
