- Ascendis Pharma (Princeton, NJ)
- …all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management. ... reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures. . Liaises with Medical… more
- Merck (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance. **Essential Duties and Responsibilities:** + Utilize extensive experience in ... in both development and lifecycle management, ensuring compliance with relevant regulatory standards. + Ensure robust technical plans, risk communication, drive… more
- Merck (Rahway, NJ)
- …in alignment with the company's business goals, and quality and regulatory compliance. **Essential Duties and Responsibilities:** _Strategic Leadership and Project ... collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality. + Provide Voice of Manufacturing input to early… 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
- 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
- Lilly (Branchburg, NJ)
- …external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and ... SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. + Ensure control… more
- J&J Family of Companies (Raritan, NJ)
- …plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today ... trends and develop mitigation plans. + Collaborate closely with R&D, Quality, Regulatory , and Manufacturing teams to identify and resolve technical challenges. +… 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...Supervises design of Clinical Pharmacology studies and manages data analysis , interpretation, and reporting + Collaborates on cross-functional drug… 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)
- …entire cycle of clinical development, including study design, placement, monitoring, analysis , regulatory reporting, and publication. Specifically, the Director ... Clinical Trial Planning, Clinical Trial Support, Cross-Functional Teamwork, Data Analysis , Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory… more