- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- 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)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and Clinical … more
- Merck & Co. (Rahway, NJ)
- …Has a deep understanding of multi-modality composition of matter manufacturing, testing, quality and supply processes from late clinical development through ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent ... online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Executive Director of Cardiovascular (Cardio-renal disease & Heart Failure) will be responsible for overseeing and facilitating research in ... at a new state-of-the-art center in South San Francisco, CA. The Executive Director will contribute to the design, prioritization, and execution of the strategic… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA ... serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Field Medical Excellence (FME) will develop field medical functional ... strategy to enable high- quality , impactful customer engagements with a consistent approach worldwide....customer engagements with a consistent approach worldwide. The FME Director will also drive operational excellence across the regions.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …change proposals and drafts stage gate proposals for formal presentation to senior management.Generates and maintains high quality risk management and ... 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
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Director of Immuno-Metabolism will be responsible for overseeing and facilitating the research in metabolic disorders & inflammation, in the ... focus on uncovering novel biology in immuno-metabolism to deliver a high- quality drug discovery pipeline.We are a research-driven biopharmaceutical company. -Our… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director ... production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of ... If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4… more
- Novo Nordisk Inc. (Milwaukee, WI)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....to make a difference? Open to hiring at the senior level commensurate with experience. The Position Builds relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to assist with overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… 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 ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Principal Scientist - Device Development Lead ( Director Equivalent) Our company's Device Development (DD) Team designs, develops, ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
