- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Applications (MAAs), and local country submissions. Collaborates with PSL/ Clinical Safety Physician(s) and cross-functional team to develop safety strategy, key ... Applications (MAAs), and local country submissions. Collaborates with PSL/ Clinical Safety Physician(s) and cross-functional team to develop safety strategy, key… more
- Insmed Incorporated (San Diego, CA)
- …issues with investigational sites and CROs.Job Requirements:Bachelor's degree required. Advanced degree preferred.Minimum of 10 years managing clinical ... lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project deadlines and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that support the clinical development and regulatory requirements of a clinical program. The Director will provide high level strategic input into ... submissions, including investigational medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA),… 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 ... study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met...and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs:… more
- Catalent (Harman, WV)
- Associate Director , Continuous ImprovementSummary:The Associate Director , Continuous Improvement will work collaboratively with the Sr Director of CI and the ... simplification, and rapid adoption of best practices.Reporting to the CI Sr Director , this person is a dedicated resource responsible for operational transformation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …franchise products, in alignment with key global and regional functions. The Global Director of HEOR & RWE Oncology will lead the HEOR and RWE implementation ... key and visible expert leader, he/she will engage the clinical , Medical Affairs and commercial organization and drive the...an effective use of HEOR and RWE methods. The Director will provide HEOR and RWE strategic direction to… more
- Catalent (Harman, WV)
- Director , Supply Chain PlanningPosition Summary: Catalent Cell & Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our ... advanced technologies and collaboration with innovative pharmaceutical, biotech and...use of MRP for work and purchase orders. The Director , Supply Chain Planning role drives the setup and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Advocate with other Enterprise Insights Data & Analytics team members to broaden application of advanced data sciences, exploration of new methodologies, and ... to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the...drive organizational action, guide the Business units and the Clinical , Medical, and Regulatory Affairs (CMR) teams on strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the Quantitative ... Clinical Pharmacology (QCP) group to develop and apply QSP...(MDT), a formal cross-functional framework for collaborative development and application of QSP within Oncology/Immuno-Oncology. ResponsibilitiesDevelop and apply Quantitative… more
- Merck & Co. (Rahway, NJ)
- …decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of ... pharmacometricians.The Director -Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating advanced pharmacometrics… more
- Merck & Co. (North Wales, PA)
- …& Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development ... & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional… 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 ... time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs. Has direct supervisory responsibility… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …and manufacturing, to drive the successful translation of preclinical findings into clinical applications . Your expertise will be critical in advancing our ... life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management. Collaborates… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of… more
- Merck & Co. (Rahway, NJ)
- …risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead ... ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key company functions.Represent Device… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for diagnostics and devices.Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and ... dossier documents for submissions globally. Ensure high quality collaboration with Clinical Biomarker and Companion Diagnostics team for development of biomarker,… more
- Merck & Co. (Rahway, NJ)
- …ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the ... on clinical trial execution.Escalates site performance issues to CRM and Clinical Research Director CRD.People and Resource Management:Manage CRA - career… more
- UT Health Tyler (Tyler, TX)
- …healthcare, together. POSITION SUMMARY The position of Quality and Patient Safety Director at UTHET is accountable for assisting the organization to improve quality, ... accreditation requirements. They will assist in the implementation of UTHET's Quality/ Clinical effectiveness function. This position supports a culture of high… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … evaluation reports (CER) Pediatric investigational plans (PIP) Orphan Drug applications Breakthrough Therapy Designation requests Clinical summary and overview ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The Senior Medical Writer is… more
