- Bristol Myers Squibb (Princeton, NJ)
- …space + Manages relationships with key internal stakeholders including Regulatory , Clinical, Commercial, Medical Affairs & Communications and external collaborators ... to develop translational analysis plans and timelines, communicate analysis results...quality scientific, technical or medical journals **Qualifications** : + PhD degree in a relevant field (eg molecular biology,… more
- Burns & McDonnell (Morristown, NJ)
- …by regulatory agencies. + Develops and conducts detailed financial analysis using a variety of computer-based software. + Develops technical reports and ... consulting services to help clients make decisions backed by business and engineering analysis . This role will contribute to the execution of technical studies and… 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 ... driving pipeline impact: population pharmacokinetics (PK) and pharmacodynamics (PD) analysis , model-based meta- analysis (MBMA), clinical trial simulations (CTS),… more
- Bristol Myers Squibb (Princeton, NJ)
- …TLs to address nonclinical translational questions + Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and ... activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives… more
- AbbVie (Florham Park, NJ)
- …and regulatory submission. + Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently ... develop protocols and statistical analysis plans. + Represent function/department on project team(s) to provide statistical input to compound/drug development and… more
- Merck (Rahway, NJ)
- …of clinical development, including study design, initiation, execution, monitoring, analysis , regulatory reporting, publication, and presentation at national ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more
- AbbVie (Florham Park, NJ)
- …and innovations in drug development spanning trial design, monitoring and regulatory submissions, as well as post-marketing access. As a Senior Manager, ... to advance medicines to our patients. Role Responsibilities: + Support regulatory submission and product life-cycle management strategy planning and implementation.… more
- AbbVie (Florham Park, NJ)
- …of experience is preferred. + Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and ... therapies highly preferred. + Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and… more
- Sanofi Group (Morristown, NJ)
- …analyses + In-depth knowledge of clinical trial design, biostatistics, and data analysis . + Proficient in regulatory requirements and guidelines for clinical ... exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first… more
- 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