- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... and Medical Access/Expanded Access (MAP)/(EAP)activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and… more
- Novo Nordisk Inc. (San Francisco, CA)
- …and academic and community thought-leaders in an assigned territory. The Rare Renal Clinical Account Manager will be principally responsible for driving disease ... leader in the rare renal marketplace. The Rare Renal Clinical Account Manager (RRCAM) will be responsible...exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications A Bachelor's degree… 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...text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …such as single event level AE causality assessment. This position requires manager review and gains industry knowledge through multiple opportunities. ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Novo Nordisk Inc. (WA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the 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 near real-time… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting process, review and approval in accordance with ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... and clinical study report (CSR): Leads statistical activities for medium...medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Aequor (Thousand Oaks, CA)
- …working hour availability at the top of the resume is seeking a Supply Chain Manager to be a part of our External Planning & Delivery Pre-Commercial Supply Chain ... group. The Manager will work from Remote US Location or in...objective is to orchestrate supply planning and delivery of pre- clinical , clinical , PPQ and commercial inventory of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject ... ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support secondary customer by… 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 OverviewThe ... QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… 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 ... Medical Guidance Train Field Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources for FMA Train Sales… 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 ... new and in-line products with resultant break-even elasticity Leads the yearly review of current pricing strategies and owns the process for developing… more
- Merck & Co. (Minneapolis, MN)
- …of care (transition of care) using approved messages and resources-Conducts appropriate business review of account performance to optimize net sales for our Company ... Clinical : Communicate to customers the clinical value...P&L (revenue and expenses); works with other stakeholders (Customer Manager , Directors, Planners) to provide input on resource allocation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... two-year program and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations. Additional key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout the… more
- Aequor (Thousand Oaks, CA)
- …and portfolio skills. This position is a key member of the GxP Management Review Governance Team within the Quality Systems and Services organization. The QA Sr ... Manager for GxP Governance, will execute required activities to...to the execution of the L0 GxP Quality Management Review . Coordinating and Facilitating material creation and preparation sessions.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight over the site Quality Control laboratories responsible for testing of pre- clinical , clinical , and commercial stage CAR-T cellular therapy products. ... providing quality oversight for site Quality Control laboratories responsible for testing pre- clinical and clinical and commercial stage CAR-T cellular therapy… more
- Merck & Co. (GA)
- …impact of those options on patients.-Understand the significance and use of clinical trials in multiple tumor types/therapies, both in impact on promoted products ... drug distribution (Oncology group purchasing organizations, wholesalers, and specialty pharmacies). Review and evaluate patterns for products purchased and prescribed… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... company goals. RelationshipsThe fellow will report to the fellowship track manager during the one-year program. Additional key internal relationships may include… more
