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Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Medical and Scientific Affairs serves a critical internal leadership and customer-facing support role, including pre- and post-market partnership to functions such as product management, sales and marketing, R&D, Clinical Affairs, Regulatory Affairs, Quality Assurance, Innovation, Strategy, Pharmaceutical Partnerships (Companion Diagnostics), and Technical Support.
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This position requires excellent interpersonal and matrix leadership skills to support effective partnerships with key internal and external stakeholders including global/regional/local HEOR leaders, Department Heads, TA Heads, CMT Leads, Development, Regulatory Affairs, and Market Access.
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The Medical Director, Global Pathology Solutions will support the development and execution of the Medical and Scientific Affairs functional strategy. Experience in the development of in vitro diagnostic products including interactions with regulatory agencies.
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Experience with product development and/or business development and strategy in medical device or biopharmaceutical industry. Provide strategic insight and tactical direction to support new product development and innovation opportunities, actively participating in prioritization of opportunities based on clinical value and strong medical understanding of physician and patient needs.
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Engage regularly with colleagues within Corporate Communications (Social Media & Corporate Brand Storytelling); across External Affairs (Patient Engagement & Advocacy and Government Affairs); and cross-functionally in Employee Communications, Market Access, Medical Affairs, HEOR, Legal, Regulatory and Investor Relations to understand each functions objectives and drive an aligned approach to product communications and stakeholder message harmonization.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements.
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Familiarity with other HSE aspects (i.e., occupational safety, plant/process safety, distribution safety, product safety/regulatory affairs, management systems, crisis and incident management) of benefit.
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Previous experience or exposure to regulatory, government, or external affairs. Veralto's Product Quality and Innovation companies-Esko, Linx, Pantone, Videojet, and X-Rite-help protect the world's food, medicine, and essentials by enabling customers to track and authenticate the billions of goods that travel the global supply chain every day.
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Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.
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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
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This role requires close collaboration with specialists in various areas including veterinary science, bacterial process development, vaccine formulation, manufacturing, bioinformatics, intellectual property, assay development, immunology, animal experimentation, pathology, regulatory affairs, and marketing.
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Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical and immunogenicity assay development.
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Minimum of 10-12 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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Prepares clinical study documents and coordinates with additional collaborators including product management, statistician, regulatory affairs, clinical research management, and contract research organizations (CROs.
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