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CMC Regulatory Affairs, oncology, small molecule, drug development, clinical development. Director, CMC Regulatory Affairs. 15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Cross-functional collaboration/interaction with Clinical Affairs, R&D, Regulatory, Quality, OEC, Legal, Global Marketing & Commercial teams. Supporting the Director of Global Scientific Affairs, in conjunction with the Sr. Manager and Project Manager in Global Scientific Affairs, with KOL management as it relates to investigator-sponsored studies (ISS) and/or collaborative research studies (CRS.
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Collaborate with commercial, market access, and medical affairs to set the agenda for and design clinical oncology research initiatives including collaborating with external KOLs to define publication strategies.
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Under the direction of the Senior Director, this position collaborates and regularly meets with key stakeholders, including Clinical Research Disease Center Managers, CTO Associate Directors of Regulatory Operations, Regulatory Affairs, Network and Satellite Program, Project Management / Monitoring and Education and Training to promote excellence and streamlined collaboration in clinical research across all disease groups.
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The Quality Manager is also responsible for clinical privilege development and management of the TUHS Medical Staff Affairs Department, internal Credentialing Verification Organization (CVO) which oversees the credentialing of TUHS physicians and APPs working in non-licensed TUHS facilities.
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We're a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. TMAC's direct-hire service, formerly known as TMAC Direct, is an award-winning executive search firm that specializes in permanent placement services for the Pharmaceutical, Biotech, Diagnostics, Device, and Life Science Research industries.
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The Director of Federal Government Affairs represents the organization’s policy and regulatory positions to elected representatives and their staff, as well as to officials and staff in the executive branch and other agencies.
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We research, develop, and commercialize innovative digital health products and solutions by bringing together the full capabilities of our team, including product strategy and management, clinical expertise, partnerships, UI/UX design, usability research, clinical research and validation, software development, AI / Gen AI, and regulatory.
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The Associate Principal Scientist will work closely with individuals from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and correctly executed to support the product strategy.
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We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability.
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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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You'll drive work for new applications in research, clinical genomics, and Reproductive Health (RHT). As a Staff Scientist in Clinical NGS, you'll work with a passionate group motivated by science, biology, and their profound impact on human health.
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Maintain clear communication channels with key stakeholders and partners (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) to ensure team resources are focused on critical asset support and related initiatives.
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Collaborate closely with other departments such as clinical operations, technical operations/CMC, translational research and regulatory affairs to ensure alignment on program objectives.
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This position reports to the Executive Director of MSLs. The MSL will have contact with internal colleagues in compliance, regulatory, pharmacovigilance, marketing, sales, research and development, medical science, medical information, market access, training, strategy and portfolio management, and HOVA. This internal collaboration is considered a fundamental and essential part of the position.
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clinical research regulatory affairs jobs Title: medical director Company: Maplight Therapeutics Inc in TX, Us
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