- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development . preferredOncology experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level.Responsible for clinical program planning and execution (from study ... leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and programmanagement,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio ... at the program level through the operational resources assigned to their program . May on occasion represent Global Clinical Operations on the Strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GDIM to drive technology-enabled process improvements. Build strong relationships with clinical development , clinical sciences, regulatory, biostats, data ... strong collaboration. Partner with other functional excellence colleagues, such as clinical development , to ensure harmonization. Responsible for maintaining… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ... expertise in the involvement of regulated activities for medical affairs, or clinical development . requiredMust possess a solid understanding of global health… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a manufacturing readiness strategy to deliver capacity ramp up to meet clinical and commercial demand.Drive capacity evaluations and lead action implementation ... information requests associated with executed capacity studies, as needed.Coordinates the development of operational models to meet clinical and commercial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication of emerging data (internal or competitive), such as congress updates and development program highlights; and budget and forecast accuracy- In a ... the direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pathology, to support design and implementation of translational pathology plans.- Lead development of the translational pathology strategic direction and ... statistical issues related to proposed business plans.- Communicate with portfolio leaders in Clinical Development , Discovery, QCP, CDx, RA, MA or other relevant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …record in executing effective project management in cross-functional drug development teams or clinical , regulatory, pharmaceutical sciences/technical operations ... for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of emerging data (internal or competitive), such as congress updates and development program highlights.- Provides medical leadership in interactions with key ... of the Senior Director/Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Commercial, Market Access and Public Affairs, Legal, Finance and Investor Relations, Clinical , Medical and Regulatory, plus other cross functional teams as needed. ... stakeholder perceptions in line with the Corporate Reputation strategy Directs development of media strategies and key message platforms, prepares/coaches senior… more
- Parexel (Trenton, NJ)
- **PXL is seeking a clinical operations lead with expertise in clinical sample logistics and proficiency in computational programming to support the ... related to clinical study samples, data, kits, and logistics. - Lead cross-functional study teams, manage vendor relationships, and oversee clinical trial… more
- WuXi AppTec (Plainsboro, NJ)
- …portfolio of services to help global customers and partners shorten the discovery and development timeline and reduce the cost of drug and medical device R&D through ... we provide world-class, globally integrated testing solutions to support drug development . We are committed to helping scientists transform innovative ideas into… more
- BeOne Medicines (Pennington, NJ)
- …BeOne's Drug Product Manufacturing site in New Jersey (Hopewell). This role will lead the site drug product MST function to support technology transfer, validation, ... role is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities. **Essential Functions:** + Serve as MST… more
- Parexel (Trenton, NJ)
- …as contracted across multiple channels and interactions such as: --Consultancy on protocol development , drug development program etc. --Medical review of ... task contracted) and according to the assigned role (Global Lead Physician GLP or Regional Lead Physician...development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …+ Lead through Internal Collaboration: Forge strong collaborations with clinical development , medical affairs, and regulatory teams to ensure seamless ... to ensure patients have access to Suns medicines. **Duties and responsibilities** + Lead the Development and Implementation of Innovative Access Strategies: … more
- Terumo Medical Corporation (Somerset, NJ)
- …**_Advancing healthcare with heart_** **Job Details/Responsibilities** 1. Strategic Planning and Execution: Lead the development and implementation of short- and ... practices and Design Control when participating in new product development and clinical activities. Fully adhere to...success of this position is the ability to successfully lead a commercialization strategy which ensures the company's ability… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …Information activities. + Knowledge of FDA and Health Canada: Drug Discovery and Development Processes; Clinical Development Tools and Processes; Medical ... unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic...create (vendor) and review ICSR (US/Foreign), PSR reports from clinical and medical standpoint, identify and respond to signal… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …Access and Preferably Buy and Bill Experience. **Key Responsibilities** 1. **Training Program Development :** - Design, develop, and deliver comprehensive 5 phase ... Manager, Sales Training of Integrated Delivery Network, Reimbursement & Oncology to lead our learning and development initiatives specifically for **HSD**… more
- Terumo Medical Corporation (Somerset, NJ)
- …products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part ... as per the Business Requirements. + Contribute with the development of the SAP Security Strategy that is well-designed,...authorizations, roles, and data access control. + Ability to lead critical issues involving SAP on GCP, Fiori with… more
