- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and...to ensure data standardization across programs. Identifies needs for process improvements as related to external data acquisition, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provides support to the portfolio or operating budget and/or resource prioritization process and serve as global coordinator with activities with Japan (forecast ... and is accountable for the development and control of Clinical Project Budget in support of Phase I-III ...and new pipeline studies in support of the annual process of extracting the optimal value out of our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... protocols.This position independently manages relationships with internal (CSPV, Regulatory, Clinical , Medical Affairs, HEOR and other stakeholders to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and PPQ as needed. Conduct data review and analysis, data-driven decision-making process , and support data transfer to the appropriate data repository - liaison ... gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position ... projects/studies and/or initiatives.Lead and manage the standardized Data Management Process and Procedures for consistency across programs and organizationProactively… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds… 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 ... ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and...This includes leading processes and technology improvements to link Clinical trial site needs, Finance and Supply forecasts that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …CMR functions within the role-based training processes (ie automation, technology, process optimization). Relationships Reports to Director or above within ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include ... and implementation plans for patient support programs Support the annual brand planning process with data driven insights Lead and execute ongoing analyses of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts frequently in ... scenarios and strategy for all pipeline products starting in Phase II clinical trials. Generates insights to support G3 decision-making for the NASH franchise… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/ Associate Director , External Manufacture as part of the Global Manufacturing ... will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external...production plan at the CMO's. Leads the management review process with CMO's based on agreed KPI's Drives and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... Practice (GCP), ICH Guidelines, federal and local regulations, and clinical research process Strong solution-oriented customer focus Good communication,… 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 ... and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit....be looking for efficiencies and improvements to the budget process and resource strategies, especially in the areas of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affiliate, and/or in collaboration with global colleagues. Relationships Reports to the Associate Director Product Quality. Regularly interfaces with multiple NN ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...by sales force Develops and maintains reporting and evaluation process for sales representative refrigerator thermometers including replacement and… more
- Bristol Myers Squibb (Trenton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Clinical Nurse Consultant** _The Clinical ... 50% of the time For position offered in California, the starting compensation for Regional Associate Director , Clinical Nurse Consultants job is a range from… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Clinical Pharmacology and Pharmacometrics - 2306103445W **Description** Janssen Research & Development, LLC is recruiting for an ... Associate Director , Clinical Pharmacology and...knowledge to projects. + Introduce new approaches to problem-solving, process enhancements, and improvement of efficiencies. + Keep up-to-date… more
- Novo Nordisk (Plainsboro, NJ)
- …and management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...the NACD portfolio + Lead and manage structured monthly process to improve planning and forecasting of resourcing across… more
- Merck (Trenton, NJ)
- **Job Description** Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and… more
