- Eisai, Inc (NJ)
- …the development of service provider strategy and outsourcing requirements for Phase I-IV clinical trials (65%): Manages the entire clinical outsourcing ... Suite#LI-TS1Eisai Salary Transparency Language:The base salary range for the Manager , Clinical Outsourcing is from :102,100-134,000Under current guidelines,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Rakuten Medical Inc. - US (San Diego, CA)
- …of global clinical development programs, from initiation through completion of clinical trials , with inspection readiness in mind throughout. The ideal ... planning and executing of GCP Quality activities to support companywide and clinical development/ clinical trial Quality activities. Successfully lead global… more
- Novo Nordisk Inc. (WA)
- …the application of those principles to trial planning and conduct of clinical trials Demonstrates proficiency with computer skills (MS Office, MS Project, MS ... Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... clinical trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical product support activities,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trial outsourcing, health sciences or related field ( clinical trials ) required.Advanced WORD and Excel skills preferred.Excellent time management ... the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional...skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling the on-time delivery of ... clinical supplies across the DSI portfolio. This role as...to CSO Supply Planning as requested.Responsible for updating relevant Trial Master Files (TMF) with CSO-related documentsSupports the CSO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight of the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to ... knowledge of CLIA/CAP regulations and GLP guidelines preferredBasic knowledge of clinical trial design; understanding of the overall drug development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement initiatives. ... and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials , Managed Access programs and Collaborative Research to the highest ... to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials , Managed Access programs and Collaborative Research to the highest… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials , and regulatory requirements. TravelAbility to travel up to 5% ... areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and ... of cell therapy reimbursement. Shape the payer value story, supported by credible clinical , health economics and quality of life messages as the market and the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …scenarios and strategy for all pipeline products starting in Phase II clinical trials . Generates insights to support G3 decision-making Assesses investments ... in payer contracts and develops patient copay program strategy in collaboration with marketing colleagues. Provides strategic guidance on how to balance these investments across the franchise Supports contracting strategy and roadmap development for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal relationships may include MA management, MA project management, Medical Communications, Clinical Trial Management, Clinical Development and Outcomes ... interests on cross-functional teams including, Field Medical Affairs, Medical Operations, Clinical Trial Management, HEOR, Market Access, Marketing and other… more
- Merck & Co. (GA)
- …the impact of those options on patients.-Understand the significance and use of clinical trials in multiple tumor types/therapies, both in impact on promoted ... with the in-scope customer team: Customer Team Leader, Key Account Manager , Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and more.… more
- Merck & Co. (Minneapolis, MN)
- …the impact of those options on the patient. Must understand impact and use of clinical trials in multiple tumor types/ therapies, both in impact on promoted ... divisions and functional areas; ensure integration with the Key Account Manager , Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may include Medical Affairs, Regulatory Affairs, Marketing, Learning & Development, Clinical Trial Management, and Clinical Development. Essential ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations.… more
- Merck & Co. (St. Louis, MO)
- …the impact of those options on patients.- Understand the significance and use of clinical trials in multiple tumor types/therapies, both in impact on promoted ... with the in-scope customer team: Customer Team Leader, Key Account Manager , Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and more.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP ... handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for...of 2 years of experience with quality support in clinical manufacture or NPI is preferred.Experience in clinical… more
