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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs.
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You will handle policy compliance by assisting in the formulation of processes and procedures for negotiation of contract awards, review contract and sub-agreements for government/regulatory compliance with policies and statutes, review new legislation, and coordinate with SDSU Offices of Research Affairs, Business and Financial Affairs and Environmental Health and Safety.
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Under the direction of the Director of the School of Nursing (SON) and in close collaboration with the College of Health and Human Services Assistant Dean for Student Affairs, and the designated Student Success Professional assigned to SON, the Student Success Coordinator will work to enhance the educational experience, facilitate graduation, support both career development and post-baccalaureate education for Nursing students.
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Partner with commercial and medical affairs colleagues to develop global market access strategies and plans, in assigned regions, for Avidity's rare disease pipeline products through various stages of development.
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Strategic Communications and Public Affairs (StratComm) serves as the official voice of San Diego State University and shares the President’s vision, values and priorities while articulating a unified message about the university’s unique story.
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Work closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs.
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Deputy General Counsel will be a key member of the Legal leadership team, assisting the General Counsel in all aspects of legal affairs. Provide counsel and advice to cross-functional stakeholders and senior leaders to set the company’s legal strategy on a broad range of matters related to new initiatives and products and other corporate, transactional, and regulatory matters.
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Supporting the company’s Commercial, Regulatory, Patient Advocacy, Corporate Communications, Medical Affairs and general administrative departments through late phase drug development, pre-commercialization, regulatory approval, and commercialization.
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Social Media Strategist (Public Affairs/Communications Specialist III) Knowledge of the fundamentals of public affairs and/or media relations, and/or some exposure to marketing and marketing research.
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Community organizing or leadership training a plus, such as certificates from: Institute for Cultural Affairs, Gamaliel Foundation, PICO National Network, Center for Third World Organizing, Mid-West Academy, RePower, Yo.
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The Senior Manager/Director of Policy and Regulatory Affairs will play a pivotal role in shaping and advancing our client's strategic initiatives across PJM and regulatory landscapes.
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As the senior Vice President, Chief Medical Officer (SVP/CMO), reporting to the Chief Executive Officer, you will serve as the lead medical voice for Halozyme providing leadership and guidance to the company and our partners/collaborators in the areas of Sub Cutaneous Drug Development with ENHANZE and Auto-Injectors, Regulatory Affairs, Drug Safety & Medical.
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Strategic Security Management: Improve, develop, and execute the organization's information security strategy, aligning with business objectives and regulatory needs. Ensure compliance with legal, regulatory, and policy requirements to minimize or eliminate fines and damages.
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SHEIN Global Security and Risk Management (GSRM) is a global security organization that oversees security infrastructure, risk management, data privacy, business fraud, governance, and regulatory compliance across SHEIN’s global footprint.
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regulatory affairs jobs Title: sr director Company: Thermo Fisher Scientific in San Diego, CA
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