- Merck (Rahway, NJ)
- …, Exercises Judgment, Goal-Oriented, Legislative Testimony, Management Process, Regulatory Affairs Management, Regulatory Communications, Regulatory ... **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in...robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the leading… more
- Merck (Rahway, NJ)
- …design, analysis , and interpretation posed by the clinical monitors, regulatory agencies, or investigators. 10. Responsible for ensuring the accuracy of ... experience. **Preferred Experience and Skills:** Broader scientific leadership in design and analysis of clinical trials; Experience with regulatory filing for… more
- Merck (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs. The AVP provides leadership and direction through senior-level and… more
- Merck (Rahway, NJ)
- …analysis requirements, internal standard operating procedures, and external regulatory requirements. + Evaluates appropriateness of available software for planned ... design, analysis , and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. + Is responsible for planning and ensuring the… more
- SMBC (Jersey City, NJ)
- …to an applicant will be based on their individual qualifications, experiences, and an analysis of the current compensation paid in their geography and the market for ... risk models for wholesale and commercial portfolios, ensuring alignment with regulatory requirements (eg, CCAR/DFAST, CECL, Basel III/IV) and business objectives.… more
- Merck (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory environment… more
- Sumitomo Pharma (Trenton, NJ)
- …with the clinical team on the statistical design of the studies, and the analysis and data presentations for the studies. **Job Duties and Responsibilities** + Serve ... statistical design, authoring statistical sections of study protocols and Statistical Analysis Plans (SAPs), and supporting trial design, including sample size… more
- Merck (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta- analysis (MBMA), clinical trial simulations (CTS) and disease progression… more
- Bristol Myers Squibb (Princeton, NJ)
- …translational data generated to support asset development and contribute to regulatory submissions. This individual will work on cross-functional project teams to ... and disease scientists and BMS members from clinical, medical, commercial, regulatory and diagnostics as well as engage external academic collaborators/Key opinion… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …all **pharmacometrics** activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. You will conduct analysis , execution and reporting of ... **population PK, PK/PD and modeling and simulation** . + **Provide pharmacometrics analysis ** and participates in activities related to analysis and reporting… more