- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary information to author the ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development or technical writing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality and/or timelines at the study level and escalates issues to the DM program lead .- Will manage DM resources of assigned studies; provides FSP/Vendor ... and issues and determines and coordinates mitigation activities; escalates issues to DM Program Lead as needed.- Attends study team meetings and provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …incumbent will contribute to creation and improvement of Clinical Development processes. Job Description:Execute an overarching safety program tailored for ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA… more
- Formation Bio (New York, NY)
- …and collaborate with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management, and Clinical Operations teams to ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our… more
- Merck & Co. (Rahway, NJ)
- …is expected to be experienced in mammalian cell culture or purification process development , tech transfer of clinical or/and commercial processes, and pertinent ... talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …partner cross-functionally with multiple functions and groups throughout the US organization, Clinical development , Research & Early Development , other ... Functions Strategy, Planning, Performance and Tracking Elevate Portfolio congress, speaker program and market development strategy, plans and execution aligning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the highest quality standards. This position reports to the Head, Global Development and Medical Affairs QA RDPVQA, and oversees multiple levels of direct reports ... work in close collaboration with Japan. This individual is a member of the Development and Medical Affairs QA leadership team and maybe extended member of the global… more
- Merck & Co. (Rahway, NJ)
- …the project as needed.-This includes the following activities:1. Is involved in late clinical development planning (LDP) to ensure that study designs are ... clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a...software for planned analyses and ascertains needs for potential program development of novel statistical methodology.7. Analyzes… more
- Formation Bio (New York, NY)
- … program manager who can oversee at least one drug development program , managing multiple workstreams while ensuring seamless cross-functional coordination ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...cross-functional teams in a matrixed environment. Partner with the Program Leader to support and/or co- lead the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …partner cross-functionally with multiple functions and groups throughout the US organization, Clinical development , Research & Early Development , other ... more patients than ever before. The Position The Rare Disease Marketing Operations Lead is responsible for assisting the Rare Disease Commercial Strategy & Marketing… more
- Merck & Co. (Rahway, NJ)
- …regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ... and/or out-of-specification approval, change management approval, etc.Support the Quality Program Lead on inter-departmental and cross-functional teams, ensuring… more
- Merck & Co. (Rahway, NJ)
- …Vice President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and ... collaboration with senior cross-functional leadership to optimize efficiencies in the clinical development space. Preferred skills include experience in the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Provides technical expertise in support of an effective calibration program that supports daily clinical production and strategically prepares ... Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with… more
- Merck & Co. (Rahway, NJ)
- …The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or ... and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development … more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development ... offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be… more
- Merck & Co. (Rahway, NJ)
- …and address drug delivery challenges Demonstrated understanding of connectivity between clinical development , chemistry, manufacturing and control (CMC) and ... Material(s):Required Skills:Adjuvants, Adjuvants, Animal Vaccination, Chemical Biology, Chemical Engineering, Clinical Chemistry, Data Analysis, Development Projects, Drug… more
- Merck & Co. (Rahway, NJ)
- …Electronic Common Technical Document (eCTD), Ethical Compliance, Global Health, Global Program Development , High Performance Team Building, Human Resource ... contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories (Research & … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …risk, drive action plan development and ultimately improve commercial and clinical planning Design, execute and lead all capability benchmarking projects in ... developing relevant skills and techniques in spirit of best-in-class CI leadership Lead development business development analytical due-diligence in… 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 ... AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI...delivery speed and efficiency through automation and GenAI application development . To help drive the AI CoE's mission, this… more
