- Sanofi Group (Morristown, NJ)
- …team). + Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.). + Coordinate clinical ... manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents. + Interact effectively with managers from various disciplines;… more
- Bristol Myers Squibb (Madison, NJ)
- …clinical development plans + This leader will supervise the development, monitoring, analysis and interpretation of clinical trials and will supervise and have ... accountability for the clinical components of regulatory filings + Will contribute to overall strategy for...documents delegated as needed **Qualifications & Experience** + MD ( PhD or other high level degree optional) **Experience Requirements:**… more
- Cytel (Trenton, NJ)
- …Affairs, including contributing to post approval study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study ... Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design post approval studies. + Writes the statistical sections… 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
- J&J Family of Companies (Raritan, NJ)
- …and simulation activities related to the research, design, implementation, data analysis , interpretation, reporting, and publication of studies for products in any ... include the generation and review of pharmacometric documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or… more
- Merck (Rahway, NJ)
- …oversee analytical investigations with a strong focus on quality and regulatory compliance. + Excel in impurity isolation, unknown peak identification, ... leadership and collaboration. + Maintain a deep understanding of the regional regulatory and business environment, including: + API and Drug Product development… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …downstream process technology transfers to CDMOs, including documentation review, gap analysis , and risk assessment. + Provide expert technical oversight of ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …through commercial launch-ensuring all products meet rigorous safety, efficacy, and regulatory standards. + Clinical Risk Assessment: Collaborate with the Global ... Safety Assessments, Health Hazard Evaluations). + Coordinate study design, analysis , interpretation, and dissemination of clinical evidence that enhances business… more
- Bristol Myers Squibb (Princeton, NJ)
- …Diseases. + Manage relationships with key internal stakeholders including regulatory , clinical and commercial and scientific communications and external ... collaborators to develop translational analysis plans and timelines, communicate analysis results....scientific, technical or medical journals. + **Qualifications** : + PhD degree in a neuroscience-related field + Minimum of… more
- Holtec International (Camden, NJ)
- …or other regulatory authorities + Experience in seismic and stress analysis of pressure vessels and rotating equipment + Experience in modular design development ... and communication skills DESIRED SKILLS + Industrial experience in the latest stress analysis codes such as ANSYS, LS-DYNA and STAAD.Pro + Prior nuclear industry… more