- 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 ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oversight of outsourced or contracted activities utilizing both performance and quality measurements.The Associate Director , SCBM Financial Reporting ... management and liaises with internal/external stakeholders on cross-functional initiatives.The Associate Director , SCBM Financial Reporting & Strategy's… 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)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... This position may propose strategies for external data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Clinical Operations (GCO) Functional Excellence ... training. Support the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate. Support and/or lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The CRA Oversight Associate Director plays an integral role in the strategic development, ... a fast paced and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to risk-based monitoring (RBM) and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, development ... of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables on time and within budget to support drug development ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the… 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 ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… 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 ... 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)
- …overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other ... 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)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...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 Development, 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....and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …organization, domain, function and role perspective. This person will report to the Associate Director , Training and Communication of the Center for Data ... outcomes.- Support the creation and us of policies, processes, data standards, data quality and enabling IT and digital technologies needed to establish and maintain… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Wednesday, May 8, 2024 Looking for a chance to make a meaningful ... and manages multiple complex global studies to support the Clinical Development Plan. The Associate Director...clinical studies are delivered within timelines, budget, and quality . A critical component of the position is leading,… more
- Sumitomo Pharma (Trenton, NJ)
- ** Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of ... highly motivated, and experienced individual for the position of Associate Director of GMP Quality ...investigational clinical trials and/or commercial phases. The Associate Director ensures compliance with GMPs, SMPA… more
- CenterWell (Trenton, NJ)
- …part of our caring community and help us put health first** The National Director , Clinical Pharmacy is a strategic pharmacy leader responsible for developing, ... and other crucial areas; as well as development of other pharmacy-related clinical initiatives to improve medication quality , cost, and appropriate use… more
