- Novo Nordisk Inc. (Boulder, CO)
- …in the development and/or implementation of processes and programs. Leverage direct manager for support on as-needed basis Physical Requirements 0-10% overnight ... Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Merck & Co. (Rahway, NJ)
- …individual is responsible to-manage/oversee a team of CTCs(Clinical Trial Coordinator).As line manager the role is critical to continuously develop future talent by ... providing training, support and mentoring to the CTCs, as well as...to the Clinical Operations team based on the Internship program , while-properly managing situations of low or non-performance.The role… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... Review protocols to ensure designs are implementable to efficiently achieve the objectives. Support activities to drive adherence to timelines, program objectives… more
- Novo Nordisk Inc. (Boulder, CO)
- … timelines. Act as point of accountability for delivery of phosphoramidites to support a cross functional program teams. Physical Requirements Approximately 5% ... 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works...ready to make a difference? The Position The Senior Manager of Specialty Raw Materials Manufacturing is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a critical part of the Center for Data Governance ... Governance and work collaboratively with the broader team to support their efforts in other areas such as Data...+ years of previous experience with a data governance program , data stewardship program or similar intent… 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 ... CROs and External Vendors for the data services they provide to support drug development processes and global submissions.This position provides expertise within… more
- Aequor (Raleigh, NC)
- …and find innovative solutions to drive efficiencies. Collaborating with SP&O Sr Manager to support function wide initiatives including crafting and running ... Remote Position - Flexible Hours Manager is open to seeing candidates with a...partners and Strategic Planning & Operations (SP&O) team to support and proactively respond to business needs including progress… more
- Novo Nordisk Inc. (Boulder, CO)
- …Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, ... a difference? The Position Novo Nordisk is seeking a highly motivated analytical support specialist to join the Analytical Development team in Boulder, CO. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... collaboration with internal stakeholders Review assigned grant requests within External Support System (ESS) aligned with Novo Nordisk's key educational priorities… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... documentation across all aspects of the compounds' life cycle management, with support from management as needed. The qualified candidate will have proven ability… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and the data governance processes surrounding these capabilities, and the data governance program in general. This role will help support the overall data ... as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Learning & Development role will design and develop engaging, innovative, ... learning to life in the flow of work. The Manager , Learning & Development will collaborate with stakeholders across...Collaboration and creativity are critical in this role to support a culture of learning and develop user-centric learning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for creating and assisting in the development of compliance program trainings and communications, including developing eLearning modules. This position ... Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining CommunicationsPlan, create,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Manager , Commercial Analytics, Respiratory will be a key member of the ... ongoing and ad-hoc analytics to track product performance as well as support Directors of Commercial Analytics in driving analyses for upcoming launches (eg,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... related documents in the Company's electronic document management system (EDMS).ResponsibilitiesRESPONSIBILITIES: Support regulatory submission activities associated with generating electronic submissions… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This ... compliance within quality systems processes. Key Responsibilities Lead the CAPA program for the CAR-T manufacturing site. Oversee metrics, trending, and reporting… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …accuracy and precision requirements primarily focused o pharmaceutical operations and support equipment Develop, test, and validate, automated and manual calibration ... measurement methods and test systems.Demonstrated knowledge of programming languages in support of instrument automationGreat time management skills and both the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized products. Lead the validation team ... and maintenance of validated systems. Coordinate technology transfer activities in support of commercialization. Serve as a technical resource to improve product… more
- Insmed Incorporated (Bridgewater, NJ)
- …plans. The Sr. Director of Program Management will utilize best-in-class program management support to provide end-to-end oversight of the program ... ethic and a positive, can-do attitude.Must be an experienced pharmaceutical/biotechnology program /project manager with experience in leading drugs through all… more
