- Merck & Co. (Rahway, NJ)
- …Atherosclerosis & Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire ... execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- …across the entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance and operational excellence in ... analytical GMP activities partnering across the network to enable clinical supplies. In this role, the Director ...raw material & MDCP SME during internal and external compliance auditsEnsuring operational excellence and drive process … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , Master Data Management (MDM) will lead a centralized team responsible for governance, stewardship, and continuous improvement of master ... Development: Build, lead, and develop a centralized MDM team (data stewards, process leads, data quality analysts) within OpEx responsible for master data… more
- Merck & Co. (Rahway, NJ)
- … clinical implementation and advancing digital pathology within our company's clinical therapeutic pipeline.The Principal Scientist ( Director ) will have the ... hybridization) testing procedures, and applicable laboratory testing regulations.Experience ensuring compliance of a clinical laboratory with regulatory… more
- Merck & Co. (Rahway, NJ)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians.This director will be part of a leadership team responsible for applying traditional ... continue to innovate our pharmacometrics capabilities on a continuous basis. The Director will be accountable for directing a team of pharmacometricians with diverse… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryThe Associate Director , Global Scientific & Value Content-Healthcare Professional (AD, GSVC-HCP), position resides in the Value & ... and provides an overview of the output of the meeting.- Process Improvement: Identifies gaps and leads initiatives such as...and plans with other V&I partners, such as Publications, Clinical and Outcomes Research. Aims to ensure the timely… more
- Merck & Co. (Rahway, NJ)
- …are seeking a highly skilled and motivated Associate Principal Scientist/Associate Director with expertise in conducting outcome researching using real world data. ... of generating Real-World Evidence (RWE).Expertise in cohort identification using clinical and therapeutic classification codes such as ICD-9-CM, ICD-10-CM, SNOMED,… more
- Merck & Co. (Rahway, NJ)
- …(CDSP) in Clinical Trial Central Labs. This includes sourcing of clinical services utilizing the Sourcing Management Process for strategic analysis of ... contract management. This role will report to the Associate Director , Clinical Trial Central Labs to support...management and other functional areas such as Legal, Privacy, Compliance , etc. Supplier Performance Management - to monitor, report,… more
- Merck & Co. (Rahway, NJ)
- …investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical ... execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This role ... principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF strategy, foster cross-functional collaboration, and… more
- Merck & Co. (Rahway, NJ)
- …clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development, including study ... and will interact externally with key opinion leaders. Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and translational work… more
- Merck & Co. (Rahway, NJ)
- …strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design, development, and ... knowledge in drug and device product development, such as manufacturing process development and validation, design control, risk management, material and molding,… more
- Merck & Co. (Rahway, NJ)
- …Product Leaders have direct impact on cost, quality, customer service, and compliance which ultimately affects access, continuity of supply, and commercial outcomes. ... and GPO Network Orchestration including: product enhancements, cross-product considerations, process and method technical changes, robustness/quality/ productivity projects. Manage… more
- Eisai, Inc (Nutley, NJ)
- …and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products ... 15 or more years significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …success. He/she is responsible to ensure their direct reports are properly trained, following process and SOPs. The Director will ensure the Senior Director , ... and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director , Global Clinical Operations on plans for successful… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical ... areas centered around rare diseases and immune disorders. Summary Senior clinical operational leader accountable for operational planning and execution of FIH,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision, ... disciplines and cultures. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ensuring compliance levels are met.Lead the ... ensure high data quality, proactively identifying and resolving issues throughout the clinical trial process . Customer Focus / Stakeholder:Engagement Lead the… more
- Merck & Co. (Rahway, NJ)
- …This is an onsite based role in Rahway, New Jersey and reports to the Systems Process Lead Director at the FLEx Center in the Pharmaceutical Operations and ... cGMP Guidelines, Communication, Cross-Functional Teamwork, Electronic Batch Records, GMP Compliance , Laboratory Experiments, Mammalian Cell Culture, Management Process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of continuous improvement in… more
