- Integra LifeSciences (Plainsboro, NJ)
- …set new standards of care. **SUMMARY** This position reports to the Director , Manufacturing Operations & Engineering and is responsible for manufacturing engineering ... projects to evaluate, analyze, and improve existing processes, implement statistical process controls, analyze and trend existing process parameters, improve… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the minimal guidance of the Senior Director , Business Development Execution, the incumbent manages and is responsible for the business ... process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development Execution. The primary function includes… more
- Merck & Co. (Rahway, NJ)
- …and clinical trial operations to guide tool selection and process optimization. Influences Technology and Workflow DecisionsContributes to decisions on internal ... responsible for the formulation and execution of automation strategy in Global Clinical Trial Operations and all the support activities within their functional area.… 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 Principal Scientist/ Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient- reported outcomes assessments, systematic reviews and… 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 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)
- 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)
- 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)
- …(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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- … Judgment, Communication, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance , Flow Cytometry, Gene Therapy, Genetic Engineering, Immunoassays, ... peptide/protein modalities). We collaborate closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, to… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, Biostatistics, Business, Cell-Based Assays, Chromatographic Techniques, Clinical Judgment, Cross-Functional Teamwork, Dosage Forms, Ethical ... scientific role tasked with working closely with the group Director to define group strategy and to lead a...standards of control strategy for residual HCPs and other process related impurities in biologics.A strong team player with… 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)
- … Clinical Judgment, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance , Innovation, Liquid Chromatography (LC), Management Process , Matrix ... Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving… 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
- 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
