Affairs and Business Franchise) Excellence in development strategy and operational implementation, highly skilled... and scientific leadership for a neuroinflammation program, including responsibility for clinical development strategy and execution...
strategy. Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials... clinical data supporting overall product scientific and business strategy. Responsibilities: Leads and demonstrates...
strategy. Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials... data supporting overall product scientific and business strategy. Responsibilities - Manages the design...
Provide financial advice and guidance to program leaders and teams Ensure the adherence to regulatory compliance procedures... and participate in groups and committees across the Program, Division and/or Organization to support strategy, special projects...
and strategy set forth by the Head of Strategic Feasibility. Advances this effort through the coordination and development of data.... Partners with key stakeholders within Global Development Operations (GDO), Medical Affairs, Medical, and/or CROs, to enable...
Market Surveillance (PMS), Pharmacovigilance (PV), Medical, Manufacturing, Regulatory Affairs, and Quality. PRINCIPAL... within the global quality management system, in compliance with global regulatory requirements. Also responsible for supporting...
data supporting overall product scientific and business strategy. Responsibilities: Manages the design... on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business...
data supporting overall product scientific and business strategy. Responsibilities: Manages the design... on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business...
management, clinical operation, clinical science, regulatory affairs and drug safety. Project management and contract...SUMMARY/JOB PURPOSE: Provides leadership within biostatistics function to develop and execute statistical strategy...
for all U.S. FDA GxP inspections, including GCP, PV, and Devices. Works closely with Regulatory Affairs leadership during inspections...About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse...
-functional program strategy and long range plans from pre-clinical development through regulatory approval and commercialization...-clinical development, clinical development and operations, regulatory affairs and commercial Experience as a PM leader...
, Quality, Regulatory Affairs, and external partners to ensure seamless technology transfers and GMP readiness. Your expertise..., Process Development, AS&T, Analytical Development, Quality, Regulatory) to establish and run the MSAT Upstream Laboratory...
departments such as Process Development, Analytical Development, Quality, Regulatory Affairs, and external partners to ensure..., Quality, Regulatory) to establish and run upstream MSAT laboratory operations Develop phase-appropriate downstream scale-down...
, and Agentic AI. Risk Experience: 10+ years in Risk Management, Technology Strategy, or Regulatory Compliance within a large... of AI. This leader will be instrumental in refining and executing the firm's Responsible AI strategy, playing a pivotal role in shaping...
Lead global market development strategy for hATTR-PN to prepare the market for nucresiran entry, including campaign... and messaging that reflects customer needs and beliefs and remains resilient to evolving market conditions Translate global strategy...
and compliance. You will also oversee regulatory affairs, departmental contracts, and vendor relations to optimize resources... that provide actionable insights, inform organizational strategy, and drive continuous performance improvement. Organizational...
across our organization including areas such as research, pre-clinical, clinical, pharmaceutical development, regulatory affairs, medical... affairs, commercial, operations, policy and government affairs, patient engagement and corporate communications, as well...
timely and cost-effective project completion. Lead cross-functional teams, including engineering, regulatory and government... affairs, and construction, to coordinate project activities and ensure alignment with project goals. Ensure the proper...
both the strategic and operational aspects of Regulatory Affairs objectives for assigned products, life cycle management... initiatives and acquisitions including NALA regulatory strategy, regulatory submissions, and interaction with regulatory...
to support a global scientific and business strategy. Extensive knowledge of clinical trial methodology, regulatory... clinical data supporting overall product scientific and business strategy. Responsibilities: Leads and demonstrates...