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Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
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This position is hybrid, based in Santa Monica, CA, and reports to the Executive Director, CMC Regulatory Affairs. The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies.
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Work closely with internal stakeholders, including sales, marketing, product development, regulatory affairs, and legal teams, to ensure alignment and execution of partnership initiatives.
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Work closely with the Data Governance Lead to develop and maintain a right size data catalog of and data lineage for commercial and medical affairs applications. For the expansion of our Business Information Systems (BIS) team, company is looking for a Data Architecture Lead with focus on the Commercial and Medical Affairs functions.
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This includes providing interventions specific to consumer IAP for medical/health and wellness goal areas. Review all medical documentation for each consumer at respite and as assigned and provide medical care consultation and coordination as needed Provide assistance coordinating overall medical care for consumers and ensuring medical follow up is done as needed Provide interventions to consumers that focus on education and skills training in relation to health and wellness issues.
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Philippines Quaker Promotional Calendar: Work with PH Quaker Category & Trade Marketing Manager to develop a consumer promotion calendar, driving profit accretive, incremental growth for PEP. Leverage our scale to drive time and spend efficiency across markets while at the same time ensuring on-time and in-full execution.
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The Senior Manager/Associate Director of Regulatory Affairs reports to the Executive Director, Regulatory Affairs and will be responsible for contributing and delivering global regulatory strategies for product development and approval in alignment with the corporate strategy for Stoke’s portfolio.
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Reporting to the Chief Medical Officer, the Senior Manager of Regulatory Affairs will be responsible for the development and execution of Sails regulatory operations and the planning, managing and tracking of regulatory submissions.
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Alumni Affairs and Development is a dedicated team supporting Harvard’s advancement activity through front-line fundraising, alumni and volunteer engagement, technology, prospect management and research, business process, events, communications, and many other areas.
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As part of the Consulting leadership team, the Managing Director - Medical Affairs will contribute to setting business direction, strategy, and priorities and take ownership for driving the overall growth and scalability of the Medical Affairs consulting business.
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To protect people, property and the environment from technology-related risks; we drive consumer protection, digital transformation, sustainable development, and urbanization. To protect people, property and the environment from technology-related risks; we drive consumer protection, digital transformation, sustainable development, and urbanization.
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Sigma, Inc is looking for an Administrative Assistant to work onsite within Clinical Trial office - Research & Academic Affairs at Beth Israel Deaconess Medical Center in Boston, MA. Sigma, Inc is looking for an Administrative Assistant to work onsite within Clinical Trial office - Research & Academic Affairs at Beth Israel Deaconess Medical Center in Boston, MA.
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With guidance from the Head, Global Medical Affairs Rhinology and Gastroenterology the new leader will be an integral part of building the global medical affairs strategy in line with the brand strategy supporting development and preparation for the launch of Dupilumab for Rhinology and Gastroenterology indications in partnership with Regeneron.
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Provides specialist medical and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and Payers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities.
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Coordinate communication and collaboration between North American Operations and Head of Departments (PM, Clinical Operations, Regulatory and Start-up, Trial Support, DM, Biostatistical Services, Medical Affairs and Quality Assurance) and clients to ensure that project deliverables and requirements related to ethics, regulatory, patient safety and data integrity are met.
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consumer affairs jobs Title: regulatory affairs in Cambridge, Anoka, Minnesota
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