- Merck (Rahway, NJ)
- …mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen ... challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors. Conducts options analysis and provides… more
- 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 ... regulations, especially as they apply to compliance, to support labeling-related regulatory activities. Scientific and technical expertise is an advantage. The… more
- Merck (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products. The incumbent must be able to ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions. + Lead the… more
- Sanofi Group (Morristown, NJ)
- …manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents. + Interact effectively with managers from various disciplines; ... protocol design, execution, dose escalation and safety, information for Regulatory authorities. **Key Internal/External Relationships:** + Internal contacts: Other… more
- Sanofi Group (Morristown, NJ)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more
- AbbVie (Florham Park, NJ)
- …of a team. Lead/develop statistical strategy for project development and regulatory submission. + Provide statistical leadership for design, analysis and reporting ... drive alignment with functional management. Partner with other functions (Clinical, Regulatory , Patient Safety, and GMA, etc.) to create development strategies for… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …ideation, concept development, product verification, and validation, legal and regulatory compliance, demonstration of product value, and stakeholder education. In ... and scientific exchange plans to contribute to product development, meet regulatory requirements, and support appropriate use. The Director of Medical Affairs… more
- Bristol Myers Squibb (Princeton, NJ)
- …OR Master's Degree with 12+ years of academic and / or industry experience OR PhD or equivalent advanced degree in the Life Sciences with 8+ years of academic and ... experience. Preferred Qualifications: + A highly motivated individual with PhD degree in life sciences with 8 - 10...strategies in 14C human ADME studies. + Understanding of regulatory requirements in the areas of drug metabolism, drug-drug… more
- Actalent (Princeton, NJ)
- …trials across multiple phases. This role ensures compliance with regulatory requirements, timelines, and budget constraints while driving operational excellence ... detailed project plans, timelines, and budgets. + Collaborate with regulatory teams for submissions, amendments, and compliance-related documentation. + Address… 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