- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics, ... to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other governance level as...is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead).Where… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- **Job Summary** We are seeking a results-driven Senior Manager , Sales Training of Integrated Delivery Network, Reimbursement & Oncology to lead our learning and ... with a keen knowledge of the 5 Ds and project management. - Conduct training needs assessments to identify...and enhance their overall performance. 7. **Market Insights and Regulatory Awareness:** - Stay informed about industry trends, competitive… more
- BeOne Medicines (Pennington, NJ)
- …effective day to day operations of the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the Hopewell, NJ ... the ability to work accurately in a busy and demanding environment. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability… more
- Parexel (Trenton, NJ)
- …will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission ... presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. ** Project...level of training or performance of team members on project work. Provide line manager with input… more
- Parexel (Trenton, NJ)
- …members while tackling complex safety evaluations that directly impact patient wellbeing and regulatory compliance. **About the Role** As a ** Senior Physician in ... and discussing issues related to review process with Line Manager / Project Leader/Designee + Interacting with internal...and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities… more
- Parexel (Trenton, NJ)
- …content review. **Document Project Management** + Act in the capacity of project manager /lead for medical writing projects, which may entail serving as the ... **Job Summary:** The Senior Medical Writer will research, create, and edit...and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical… more
- Parexel (Trenton, NJ)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials ... applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational...(DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study… more
- Integra LifeSciences (Princeton, NJ)
- …to advance patient outcomes and set new standards of care. The Manager , Contracts and Vendor Management, is responsible for overseeing the Information System's ... strategy. This role ensures compliance with best practices, legal and regulatory requirements, optimizes software licensing, and manages vendor relationships to… more
- WuXi AppTec (Plainsboro, NJ)
- …the success of new and existing services. This position will report to the Senior Director of Business Development, TIDES Discovery, and will help to support TIDES ... members to complete RFQ/RFPs + Work closely with all WuXi business units, project management teams, and marketing to ensure coordination of efforts and ensure good… more
- Parexel (Trenton, NJ)
- …in assigned studies and propose /execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction Business ... in study planning with feasibility leaders, solution consultants + Participate in team project and investigator meetings + Provide training of study teams on TA… more
- Ascendis Pharma (Princeton, NJ)
- …mark. We offer a dynamic workplace for employees to grow and develop their skills. The Regulatory Project Manager will be an integral part of Global ... Affairs and 3 years of experience performing directly relevant Regulatory Project Management activities within the pharmaceutical and/or biotechnology… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. -… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …RA in project team meetings and provides expert interpretation of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory ... on global project teams (Pharmaceutical Development, Quality, Manufacturing, Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary:** The Senior Manager , Global Capital Project Delivery supports ... capital projects and lifecycle execution of these capital projects with project controls methodologies in accordance with the Capital Solutions Governance model… more
- Oracle (Trenton, NJ)
- …data center facilities at scale and at pace. This team comprises experienced project managers who work collaboratively with vendors and internal teams to ensure the ... construction and network projects. They bring a wealth of expertise in project management, technical design, and on-site construction, ensuring that our data centers… more
- Oracle (Trenton, NJ)
- …collaborating with external vendors, contractors, and suppliers to ensure alignment with project goals. + ** Regulatory Compliance** : In-depth knowledge of ... facilities at scale and at pace. This team comprises experienced project managers, commissioning experts, and construction specialists who work collaboratively to… more
- Ryder System (Trenton, NJ)
- …here (http://ryder.com/job-applicant-privacy-policy) ._ **Job Description** : **Summary** The Senior Manager Environmental Engineering is responsible for ... The position reports to the Director, Environmental Engineering and will supervise Project Engineers and Manager , Environmental Engineering staff, manage Company… more
- J&J Family of Companies (Titusville, NJ)
- …the different project organizations, vendors, sites, and partners. Daily, the Senior Manager partners with Operations, MSAT, IT, Quality, 3rd party partners, ... member of Johnson & Johnson's Family of Companies, is recruiting for a ** Senior Manager - CAR-T Execution (Automation) Systems** Learn more at… more
