- Merck (Rahway, NJ)
- …and routes of administration, including inhalation, implantation, and injection. The Associate Principal Scientist will lead the definition and execution of design ... performed by external partners. + Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, design… more
- Bristol Myers Squibb (Princeton, NJ)
- …activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives ... Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and regulatory interactions as needed **Skills/Knowledge… more
- Bristol Myers Squibb (Summit, NJ)
- …strategies, process risk assessments, etc), inspection readiness, and technical regulatory submissions. The Sr. Principal Engineer will support commercial product ... verification. The role collaborates across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of… more
- Bristol Myers Squibb (Princeton, NJ)
- …matrixed environment + Ability to successfully navigate internal MLR (medical, legal, regulatory ) review processes + Demonstrated project management experience + ... P2P marketing initiatives to inform and shape brand strategy + Through strong project management, work closely with internal stakeholders and key agency partners to… more
- Merck (Rahway, NJ)
- …and Technical Units, including external suppliers. + As required, participate in Regulatory Agency inspection activities. + As required, participate as CSV Subject ... understanding of recently published health authority guidance(s). + Knowledge of regulatory trends and initiatives such as computer software assurance. + Knowledge… more
- AbbVie (Branchburg, NJ)
- …area of responsibility. + Applies advanced technical writing skills to prepare project protocol, and final reports to support product registration and/or business ... + Related knowledge in Product Quality, Quality Control Lab Operation and Regulatory requirements is required. + Ability to work independently to meet operational… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …the timely execution of statistical and research methodological components to meet project objectives and has a thorough understanding of current requirements for ... statistical expertise and delivery of analyses. + Actively participate in project /study team meetings. Develop statistical sections of protocols; participate in… more
- Merck (Rahway, NJ)
- …in medical/legal/ compliance (CRT) reviews + Understanding of the US and Global regulatory stages and requirements + Job Owner - Fully responsible for asset ... solving problems and making decisions. + Planning: Tactical, Strategic: Advanced project planning and management experience, including the ability to contribute to… more
- Humana (Trenton, NJ)
- …a part of our caring community and help us put health first** The Medical Director relies on medical background and reviews health claims. The Medical Director ... requires an in-depth evaluation of variable factors. **Job Profile** The Medical Director actively uses their medical background, experience, and judgement to make… more
- Merck (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director ... and manufacturing to manage clinical development projects; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate… more
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