- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team ... methods and processes in industry setting. required Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis is an ... oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence...Import/export requirements to the extent that there is overall recognition of global differences exist and understanding of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is required:PhD in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years of relevant experience. ... an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position supports ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees typically ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The ... Associate Director Global Oncology Value Access & Pricing will...assigned oncology asset(s). This person will report to the Sr Director, Global Oncology Value Pricing & Access, and… 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 ... business development goals through the successful negotiation and execution of research and strategic partnership contracting agreements. In collaboration with the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... or regional project or be partnered with a more senior project manager in support of a larger, more...accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The ... Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Senior ... Global Head RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research , ICH GCP Principles and the application of those ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo... Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire...percent of the time to manage future or ongoing clinical research projects. Qualifications Education MD, DO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThe Associate ... procedures, and regulations, for their assigned TA. The AD partners with senior colleagues in developing and implementing improvements in medical review processes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/Lead Regulatory Scientist/ Sr . Manager Regulatory Affairs. ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Position Manage and oversee all assigned projects/products/processes. Assist the Director/ Associate Director in assuring Novo Nordisk compliance with internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts frequently in ... collaboration with internal management and senior level global stakeholders Interacts internally with Strategic Pricing & Contracting, Finance, Brands, Medical… more
- Insmed Incorporated (Bridgewater, NJ)
- …our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, Commercial Learning & Development, will be a key member of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A minimum of 5 years' experience required (Pharmaceutical industry, laboratory, or clinical research experience) An intermediate to advanced proficiency in ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director. Works… more
- Merck & Co. (Rahway, NJ)
- …& Respiratory Therapeutic Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic ... Job DescriptionThe Associate Vice President (AVP) will be responsible for...and tactical role in overseeing the scientific direction of clinical programs involving translational research and early… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Senior Director or Director, Business Development Execution, the primary function includes coordinating various GRACS ... regulatory compliance.Work closely with the Corporate Business Development, our Research & Development Division Global Alliance Management, Integration Management… more
