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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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Join Our Crew Senior Manager, Technical Writer, Regulatory Affairs (Remote) Philadelphia, PA. About the Position Reporting to the Associate Director, Medical and Regulatory Writing, the Senior Manager, Regulatory Technical Writer will be a key member of the Clinical Development organization and interface with cell therapy clinical, nonclinical, and manufacturing research personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators.
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In coordination with the commercial strategy team, serving as day-to-day lead and strategic legal business partner to the commercial, medical and regulatory affairs teams, as well as patient advocacy/support teams, in connection with the Company's efforts to commercialize products.
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Provision of legal services will include: In coordination with the commercial strategy team, serving as day-to-day lead and strategic legal business partner to the commercial, medical and regulatory affairs teams, as well as patient advocacy/support teams, in connection with the Company’s efforts to commercialize products.
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Legislative Initiatives: Oversee the department’s efforts to understand and provide guidance on matters coming before City Council that have an impact on the Streets Department’s operations; supervises the Department’s Legislative and Regulatory Affairs Manager who coordinates such matters on a day-to-day basis.
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Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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Collaborates with study team members (including Clinical Operations, Drug Safety, Regulatory Affairs, Precision Medicine, Project Management) to ensure that key milestones are met on time and with high quality.
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Collaborates with Student Affairs and Global Centers to support and improve student and exchange visitor services/initiatives. Reporting to the Senior Associate Provost for Academic Enterprise Initiatives, the Executive Director for International Services will successfully lead employee visa programs and export compliance and will, as needed, provide support to student and exchange visitor services.
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As a High Experienced First Officer, you will impact PSA Airlines' business growth by aiding in safe and efficient flight operations and regulatory requirements of all activities related to flight.
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This position interfaces with multiple Exelon departments, including Governmental and Regulatory Affairs, Legal, Rates, Engineering, and Operations, and works with all levels of Exelon leadership.
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As Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC) Manager, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
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OR working experience with implementation of HIPAA and other healthcare-related regulatory frameworks as applied to data management; OR working experience with electronic data management systems in the field of healthcare and/or biomedical research.
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The Associate gains independence by: performing experiments, analyzing resultant data, publishing original findings, applying for funding, communicating results in presentations at the Center and at conferences, mentoring students, and through participation in leadership and administrative activities offered through Academic Affairs.
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The Senior Compliance Manger will be part of the Core Compliance team and will work under the general direction of the Chief Compliance Officer to lead, develop, and execute the policy governance, compliance monitoring and testing, compliance education, and regulatory change management programs.
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This role will have a particular focus on litigation management and strategy, program excellence, data integrity, process improvement, risk mitigation and regulatory compliance. Provide guidance on interpretation and application of existing and new regulatory and employment law requirements.
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regulatory affairs jobs Title: sr regulatory affairs associate Company: Cardinal Health in Philadelphia, PA
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