- 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
- 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
- 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
- Lilly (Indianapolis, IN)
- …areas which will inform decisions and strategies for scientists, project teams, and management, ultimately enabling organizational and corporate initiatives. ... areas which will inform decisions and strategies for scientists, project teams, and management, ultimately enabling organizational and corporate initiatives… 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
- Lilly (Indianapolis, IN)
- …and adoption of best practices. + Compliance: Ensure adherence to regulatory requirements, data privacy, and security standards. **What You Should Bring:** ... for innovation and continuous learning. + Compliance Awareness: Knowledge of regulatory , privacy, and security standards relevant to the pharmaceutical industry.… more
- Lilly (Indianapolis, IN)
- …and execution that enable efficient delivery of these data + Contribute to project decisions related to global clinical data execution options + Ensure strong ... organization at appropriate internal and external venues. + Maintain awareness of regulatory requirements, particularly those related to the US, EU, Japan, and China… more
- Takeda Pharmaceuticals (Boston, MA)
- …clinical + Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors ... industry standards applicable to the design, analysis of clinical trials and regulatory submissions. + Strong statistical programming skills + Excellent oral and… more
- Otsuka America Pharmaceutical Inc. (Boise, ID)
- …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
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …campus, while tracking and reporting progress toward sustainability goals + Partner with Project Engineering and Project Managers to ensure the smooth transition ... to safety guidelines and policies and enforcing compliance with California state, regulatory , and federal EPA regulations + Oversee the repair, maintenance, and… more