- Bayer (NJ)
- …of new and revised labeling in accordance with FDA requirements and provides regulatory expertise and guidance for labeling operations and strategy to deliver high ... especially as they apply to compliance, to support labeling-related regulatory activities. Scientific and technical expertise is an advantage....this unique opportunity, and want to impact our mission Science for a better life, we encourage you to… more
- Bristol Myers Squibb (Madison, NJ)
- …. The **Clinical Scientist Program Lead** reports through the Clinical Science function which provides scientific expertise necessary to design and deliver ... of innovative protocols and data packages for CSRs and Regulatory Filings. The Program Lead oversees all clinical studies...program(s). * Serves as a member of the Clinical Science Leadership Team and Global Program Team * Drives… more
- Sanofi Group (Morristown, NJ)
- …Global Medical Affairs, NA Corporate Integrity Agreement Monitors, Legal, Regulatory , Finance, Ethics & Business Integrity, Purchasing, Field Medical, ... publications), etc.). Effectively collaborate with Medical Leads & Medical Science Liaisons on investigator communications. Conduct routine critical analyses of… more
- Bristol Myers Squibb (Princeton, NJ)
- …functional partners + Supports strategy for dose selection, dose justification and regulatory filings + Reviews and approves relevant scientific data and reports for ... regulatory filings + Develops technical/leadership skills of clinical and...collaborative, supportive learning environment. Requirements: + Ph.D. in pharmacokinetics/pharmaceutical science or relevant field; OR + PharmD with post-doctoral… more
- Bristol Myers Squibb (Princeton, NJ)
- …fate/effects studies and environmental risk assessments according to appropriate international regulatory guidelines. This role will lead and participate on diverse ... risk assessments and environmental fate/effects studies focused on global regulatory frameworks, technical knowledge and emerging scientific trends; Lead matrix… more
- Bristol Myers Squibb (Princeton, NJ)
- …we are inspired by a single vision - transforming patients' lives through science . In oncology, hematology, cell therapy, immunology and cardiovascular disease - and ... institutes best practices with regards to planning, execution, interpretation and regulatory submission of clinical projects and studies. Provides guidance and… more
- Bristol Myers Squibb (Princeton, NJ)
- …expertise in disease biology, neuroinflammation and patient segments to assist science driven strategies for the development of the neuroscience pipeline. **Position ... Diseases. + Manage relationships with key internal stakeholders including regulatory , clinical and commercial and scientific communications and external… more
- J&J Family of Companies (Raritan, NJ)
- …impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job ... Innovative Medicine is informed and inspired by patients, whose insights fuel our science -based advancements. Visionaries like you work on teams that save lives by… more
- Merck (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... and interpretation of data. + Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and… more
- Merck (Rahway, NJ)
- …Mentorship, Process Characterization, Process Control, Process Design, Process Optimization, Regulatory Submissions, Risk Consulting, Risk Management, Science {+ ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more