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The Army public affairs specialist participates in and assists with the supervision and administration of Army public affairs programs primarily through news releases, newspaper articles, Web-based material and photographs for use in military and civilian news media.
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Communicates with involved campus entities, such as the Deans of Student Affairs, the AVP of Academic Affairs and BETA and CARE Team. Ensures continuity of care for students is also being managed through these entities in accordance with Maryland Mental Health Code and professional ethical standards.
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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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The Program Leader will lead a cross-functional team across clinical operations, regulatory affairs, clinical pharmacology, biomarkers, CMC, non-clinical, and medical to deliver against the program strategy.
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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. You’ve acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K’s, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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Supports the Director, Regulatory Law, Government Affairs and Trade Compliance in managing risk within the defined scope of responsibility. Reports to: Director, Regulatory Law, Government Affairs and Trade Compliance.
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Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Provide CMC regulatory review for clinical protocols and investigator brochures, etc.
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POSITION SUMMARY Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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The Deputy Chief of Staff advises, collaborates, and works closely with senior UW leadership on behalf of the President and Provost to advance the University's mission and ensure strategic alignment within Academic Affairs functions.
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In this role you will lead global public affairs campaigns around key regulatory and public policy topics that impact the video game and entertainment industry. Lead strategy and execution of public affairs campaigns globally in partnership with the public policy team.
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AURORA UNIVERSITY PROVOST AND EXECUTIVE VICE PRESIDENT FOR ACADEMIC AFFAIRS Aurora University (AU), a private university located in Aurora, Illinois, invites nominations and applications for the position of Provost and Executive Vice President for Academic Affairs (Provost.
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Interns will work closely with MCRA experts and mentors to gain critical hands-on knowledge in Regulatory Affairs, Biocompatibility, and Toxicology. MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization.
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Minimum of 10 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
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Two years post-masters experiences working in fraternity & sorority affairs, housing or residence life. Knowledge of and a working understanding of current best practices in Fraternity and Sorority Affairs, health and safety practices and the structure of NIC, NPHC, MGC and NPC organizations.
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In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs, GCTO and others to implement the regulatory strategy for the DHT/SaMD in global clinical trials.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Amgen
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