- Novo Nordisk Inc. (New York, NY)
- …Nordisk's Rare Disease portfolio. The mandate of STARS is to facilitate the development and to coordinate the execution of the long-term strategy, defining a ... areas, new products in the pipeline, and products acquired through business development efforts in existing and new areas. The STARS team collaborates and… more
- Merck & Co. (Rahway, NJ)
- …should have solid understanding of integration and partnering for Pharmaceutical development / CMC with Quality, Regulatory, Operations, Non -clinical, Clinical, ... healthcare. The Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics as well as… more
- Merck & Co. (Rahway, NJ)
- …laboratory / regulatory documentation. Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and ... regulatory filings. Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small group of… more
- Merck & Co. (Rahway, NJ)
- …of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets ... a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functions. Responsible to provide enough training for the related GMP and non -GMP activities involved with QA System Management processes.- Cross-Functional Team ... diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... achieve the objectives.Support activities to drive adherence to timelines, program objectives and monitoring plans.Accountable for accuracy and timeliness of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team support to uphold the ethical conduct of interventional, non -interventional, investigator-initiated trials, Managed Access programs and Collaborative Research ... process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted business functions.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research, translational biomarkers, companion diagnostics, bioinformatics, clinical development , medical affairs, regulatory etc.).Identify and interact with ... position will define and oversee the translational strategy/plan for oncology therapeutic program /s in global R&D. The successful candidate will set goals and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... of the Novo Nordisk, Inc. (NNI) Procurement Methodology through Category Management and Strategic Sourcing activities. This position will ensure the acquisition… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … program tailored for AEs from end-to-end: understanding predisposing non -clinical and clinical factors, diagnosis, effective management during clinical ... areas centered around rare diseases and immune disorders. Summary A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(OPT) leader; Responsible before the IST for the creation and execution of development strategy for a program .Additional non -study related activities: ... representative: Creates early development plan and contributes to overall development Strategy; Develops program biomarker strategy; Achieves endorsement for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Diagnostics, Translational Sciences, Global Clinical Operations, Biostats and Data Management and Clinical Development . Responsibilities Designs and leads ... partners. Contributes to RFP process towards selection of CDx assays and co- development partners.Represents Companion Dx Dept on non -project initiatives and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …representative: Creates early development plan and contributes to overall development Strategy; Develops program biomarker strategy; Achieves endorsement for ... before the IST for the creation and execution of development strategy for a programAdditional non -study related...w/KOL and prepare material for KOL interactions on a program -based need; Peripheral involvement in Business Development … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Budget; Establishes effective communication between CRO / vendors / AROAdditional non -study related activities: Occasional senior management interactions at ... around rare diseases and immune disorders. Summary Oversees typically a single non -pivotal trial (small size, standard complexity in design and geographic scope).… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential? ... and pipeline/launch products for aligned therapeutic or franchise area(s). Manages development and performance for team of direct reports. Relationships Reports to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pricing research, scenario modeling, etc. Observe/Understand the process of customer-specific program development and execution to improve product access, ... need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential?… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management , and Non -clinical Development . Essential Functions ... to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program . Relationships The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of emerging data (internal or competitive), such as congress updates and development program highlights.Provides medical leadership in interactions with key ... team lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs projects within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …track record of leading Sales functions at a large, multinational enterprise; Project/ Program Management , Product launch is a plus Demonstrated ability to ... passion and engagement are met with opportunities for professional and personal development . Are you ready to realize your potential? The Position The Executive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for performing training and process improvement projects for the Gown Training Program . This position is responsible for quality and maintaining the highest ... and all applicable regulations.Key Responsibilities Support and lead the Gowning Training Program and be responsible for the gowning training and qualification of… more
