- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Biomarkers, etc.) Clinical Safety , CROs and External Vendors for the data services they provide to support drug development processes and global ... developing optimal approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and… more
- Merck & Co. (Rahway, NJ)
- …and scientific decision making and authority, eg generating and evaluating data ). Conduct residue chemistry and metabolism studies to support domestic and ... on electronic recordsKnowledge of US-FDA and EU-CVMP guidelines on veterinary drug development for food producing animalsProficient in written communications and in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lifecycle - Collaborates with Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data of any source to identify ... veterans and people with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership… more
- Eisai, Inc (Nutley, NJ)
- …authorities.Interface with other Eisai Departments and affiliates for dissemination of Drug Safety information, including training and orientation programs for ... for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as a ... and pharmacovigilance, CROs and External Vendors for the data services they provide to support drug ...team as an extended part of committee. Advise Study Data Manager on complex vendor management issues… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... data innovation, insights and analytics, delivering patient support solutions,... analytics and market research with customers. The CI&A manager will work and collaborate with multiple levels of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... ready to make a difference? The Position Analyzes and summarizes available data and creates / authors responses to unsolicited inquiries from healthcare… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of ... Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset… more
- BioAgilytix (Durham, NC)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... life-changing, life-saving therapeutics to the patients who need them.The Archive Manager is responsible for the management, operation, and procedures related to… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager of Supply Chain and Logistics plays a crucial role in supporting ... The role also requires contributing to build and maintain Insmed's master data management practices, as well as implementing and monitoring DSCSA compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... data innovation, insights and analytics, delivering patient support solutions,...Relationships This individual contributor role reports to the Sr. Manager of Business Assurance and works closely with various… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient safety , data , CMC, IP, patient selection, ... processes.Providing proactively regular strategic and tactical status updates to their manager and governance on progress, risks, opportunities and challenges, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …not limited to: Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, ... Clinical Research Organizations (CROs) and vendors across all phases of drug development; Ensures compliance with established clinical and regulatory guidelines,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …ensuring consistent quality standards are maintained. Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are ... as requested. Identify and implement process improvements related to safety , environmental, quality, compliance, productivity, yield, and cost. Implement process… more
- Catalent (Manassas, VA)
- …Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards.Shift: 2nd Monday-Friday 1PM-9PM. ... organization of all related documents: MMRs, specifications, BPRs, Food Safety and Quality Plans, and any other documents as...completed. Utilize the computer to enter and track result data ; Report any deviations to the Quality Systems and… more
- Novo Nordisk Inc. (Boulder, CO)
- …Relationships The Technical Team Lead, API Manufacturing reports to the Senior Manager , API Manufacturing. The Technical Team Lead works with Chemical Development, ... Team Lead, API Manufacturing acts as a delegate for the Senior Manager API Manufacturing. Essential Functions Responsible for the manufacture of oligonucleotide API… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE final BR - / hour Regulatory Writing Manager In this vital role you will prepare and coordinate the preparation of regulatory submission documents that ... sections including the Summary of Clinical Efficacy, Summary of Clinical Safety , Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …diseases, researching on real-world evidence, and creating hope for all facing illness. Manages Drug Safety Data Systems to ensure the timely creation, ... Safety projects. Analyzes study protocol and project requirement(s), identifies drug safety data quality rules, and design and program reports based on… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … safety topics for products working closely with Drug Safety Global Safety Team (GST) Chair (Medical Director). The Manager , Drug Safety will ... products ( drug and device) including signal tracking, safety data analysis, and presenting in the...author safety aggregate reports as needed. The Manager , Drug performs medical analyses for risk… more
