- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations .The Senior Director , Clinical ... systems and procedures to ensure efficient day-to-day operations meeting company and affiliates’ clinical trial...regulatory guidelines, operating systems and procedures in clinical trials and maintains Clinical Operations… more
- Eisai, Inc (NJ)
- …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 ... in MS Office Suite with a good understanding of other IT systems for contract management and clinical development.#LI-TS1Eisai Salary Transparency Language:The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Director , QA Operations as part of the Quality team based in Raritan, NJ. ... Role Overview The Director of Quality Operations , CAR-T is...harmonization and alignment with Quality Policies, Guidelines, Programs and Systems . Responsible for all aspects of incoming and final… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems , including investigation/deviation ... as needed. The Role Provides strategic direction to the QA Systems staff supporting Investigation/Deviation/ CAPA Management, Change Control, Risk Management,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) ... (eg, CRO); oncology, immunology, or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus… more
- Merck & Co. (Rahway, NJ)
- …facilitate process development, streamline clinical supply and improve efficiency of operations .- -Maintaining FLEx facility and equipment systems in a state ... complex is shared across two co-leader roles, and includes operations that support end-to-end GMP clinical supply...as well as oversight of the Enterprise Resource Planning systems (SAP, PAS-x) and the Data Analytics output of… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to identify,… more
- Catalent (Philadelphia, PA)
- …and Computer System Validation documentation review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle. ... Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function...leadership and Quality Management support within each of the Clinical development supply division. This individual will have responsibility… more
- Merck & Co. (Rahway, NJ)
- …role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the respective clinical programs.Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical ... working and new technologies.Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in support of Phase I-III clinical studies. Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always ... for the development and control of functional budget in support of global operations of RD unit. Partner with global function leaders to ensure budgets are… more
- Merck & Co. (Rahway, NJ)
- …enable efficient and seamless access to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, ... biopharma research, such as high-throughput screening devices, liquid handling systems , mass spectrometers, gene sequencing platforms, and laboratory information… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …interacts, and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations ... Agreement (CIA)) regulatory requirements (eg PDMA reporting) and the systems that support these processes (eg the transparency system)....with senior leaders from Legal, Finance, Operations and Market Access as well as others across… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, ... Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS)… more
- Merck & Co. (Rahway, NJ)
- …according to quality, compliance and timeliness requirements; expertise in SAS and clinical trial programming, systems and databases including advanced knowledge ... and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory, QP2, CSRM, Data Management and Statistical Programming to… more
- Merck & Co. (Rahway, NJ)
- …of reporting, analytics, and visualization solutions that assist local clinical operations and administrative business processes.Pharmaceutics & Regulations: ... you will play a crucial role in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - Engineering Auto Eng… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …Pharmacy Staff (Pharmacist, District Managers, etc.) as well as health systems -based Clinical Pharmacists and Local Pharmacy Societies. Essential Functions ... portfolio of approved products with local pharmacy colleges Medical Groups & Health Systems Partner with clinical pharmacists within local medical groups and… more
- Merck & Co. (Rahway, NJ)
- …The Senior Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the ... projects, and the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist -… more
- Eisai, Inc (Nutley, NJ)
- …exceed sales objectives. This will be accomplished by conveying complex clinical information to customers and key stakeholders regarding FDA-approved indications of ... and Company regulations and guidelines; apply these standards across all business operations to ensure compliance with our company and industry policies (ie… more
- Merck & Co. (Rahway, NJ)
- …The Associate Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the ... projects, and the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Associate Specialist -… more
