- Organon & Co. (Jersey City, NJ)
- …relevant regulatory documents of assets in Organon portfolio. + Ensure that non- clinical studies are conducted in compliance with relevant regulations, ... **Job Description** **The** **Position** The Non- Clinical Safety Assessment Representative within the Non- Clinical...manage multiple projects and shifting priorities. + Ability to process and articulate complex ideas in a manner that… more
- Merck & Co. (Rahway, NJ)
- …medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle ... and the further study of marketed compounds. In executing these duties, the Senior Director may: Supervise the activities of Clinical Scientists in the execution… more
- 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)
- …effective, innovative medicine.Summary, Focus and Purpose:The Cardiovascular and Respiratory Clinical Research Director -has primary responsibility for planning ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage...inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here… 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
- 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)
- …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)
- 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)
- …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)
- …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
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The** **Position** The Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting in the ... phase 2a studies and will report to the Executive Director , TMED Operations. The CTM will support the TMED...vendors. The CTM will also assist to manage the clinical study team and help to coordinate meetings 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)
- …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)
- …our existing and pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ ... reporting of final clinical trial results.In addition to responsibilities associated with clinical research, the Clinical Director at this level will be… 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)
- …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
