- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership ... with Clinical Safety Scientist Product Lead, Product Safety Lead...Lead and PSL - May serve as a project manager for other activities involving assigned product(s) or clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, etc.) Clinical Safety , CROs and External Vendors for the data services they provide… 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 ... reporting of clinical trials. preferred- Having knowledge of all phases of drug development, including early and late phase clinical development and submission… 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, market ... processes.Providing proactively regular strategic and tactical status updates to their manager and governance on progress, risks, opportunities and challenges, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the data services they ... provide to support drug development processes and global submissions. This position provides...and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as… 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
- 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...simultaneously Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Drive continuous… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to resolve issues. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Require minimal direction to complete ... citizenship status, uniformed service member or veteran status, or any other characteristic protected by law. Legend Biotech maintains a drug -free workplace. more
- Catalent (New York, NY)
- …as assigned.The Candidate Proven, successful track record as sales executive or brand manager in a leading company operating in the cosmetic industry, minimum 3 ... rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to the manufacturing of cell therapy products for ... SOP's and WI's. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Immediately alerts supervisor/ manager … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements. Support manufacturing investigations, create/revise ... forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable regulations and ... investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring deviations and health authorities'… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or material handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for improvement or correction. ... dedicatedly driving compliance. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned,… more
- Fidelity TalentSource LLC (New York, NY)
- …be nurtured. Your innate personality makes you an ideal candidate to be a Relationship Manager . The Expertise We re Looking ForSeries 7, 63 & 65 and Life Insurance ... weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily...or state law, Fidelity will also conduct a pre-employment drug screen, which will review for the following substances:… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …closely related field and five (5) years of experience as a Senior Manager , Data Science (or related occupation) researching and building scalable AI solutions using ... and two (2) years of experience as a Senior Manager , Data Science (or related occupation) researching and building...weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:The Role The FAL CA Risk Manager is responsible for the accurate and timely reconcilement and processing of Domestic and International Corporate ... as designee for controls as necessary.Work with the department manager to ensure the timely updating of all P&Ps...weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… more
- FirstEnergy Corp (Jersey City, NJ)
- …communities stronger. FirstEnergy (NYSE: FE) is dedicated to integrity, safety , reliability, and operational excellence. Headquartered in Akron, Ohio, FirstEnergy ... & Light, a subsidiary of FirstEnergy Corp [JCPL] The NJ Reliability Program Manager possesses a sharp business mind and proven ability to strategize and implement… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …a closely related field and five (5) years of experience as a Senior Manager , Data Science (or closely related occupation) building AI/ML models in a financial ... and two (2) years of experience as a Senior Manager , Data Science (or closely related occupation) building AI/ML...weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… more
- Bering Straits Native Corporation (Newark, NJ)
- …a timely manner.Notify Operations Supervisor, Transportation Coordinator and/or Project Manager of any route variations/changes.Ensure that any required detainee ... is obtained from the transferring facility/agency prior to departure.Report any safety related transportation issues immediately and complete a vehicle repair order… more
