- J&J Family of Companies (Raritan, NJ)
- …clinical study reports and supports preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with colleagues ... treatment and supports the interpretation and reporting of results + Assists Regulatory Affairs in determining requirements for any corrective actions or health… more
- Merck (Rahway, NJ)
- …development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may ... Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects… more
- Bristol Myers Squibb (Princeton, NJ)
- …on translational data generated to support asset development and contribute to regulatory submissions. This individual will work on cross-functional project teams to ... scientists, as well as BMS members from clinical, medical, commercial, regulatory , and diagnostics. Individual will also engage with external academic… more
- Merck (Rahway, NJ)
- …in partner organization and to management and governance teams. + Support regulatory filing by authoring and reviewing regulatory submissions and interacting ... context of broader process and product development. + Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing … more
- Bristol Myers Squibb (Madison, NJ)
- …data to support development + Serving as principal functional author for Regulatory submission, study reports, and publications + Provides oversight and medical ... of the literature + Keeps abreast of development and regulatory issues related to other competitive or relevant compounds...**Degree Requirements** + Advanced degree(s) in relevant field: MD, MD/ PhD (or x-US equivalent) and clinical expertise in a… more
- Merck (Rahway, NJ)
- …development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership ... relationships with internal stakeholders, including packaging commercialization, quality, analytical, regulatory , manufacturing, Device Development and Technology, Technical Product Leaders,… more
- Merck (Rahway, NJ)
- …substance and drug product container closure systems including mold qualification and regulatory compliance. To act as master data stewards and support enterprise ... commercialization teams across the end to end supply chain, and analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership and… more
- Astrix Technology (Monmouth County, NJ)
- …and benefit-risk assessment reports + Ensure all documents are compliant with regulatory guidelines (ICH, EMA, FDA, etc.), internal SOPs, and quality standards. + ... Collaborate with cross-functional teams including drug safety, regulatory affairs, clinical development, and biostatistics. + Interpret and synthesize complex… 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...and reporting + Collaborates on cross-functional drug development teams, regulatory submissions, and departmental initiatives; serves as Clinical Pharmacology… more