- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… 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 determines and coordinates mitigation activities; escalates issues to DM Program Lead as needed.- Attends study team meetings and provides information on… more
- Formation Bio (New York, NY)
- …direction, and support to cross-functional teams in a matrixed environment. Partner with the Program Leader to support and/or co- lead the program Drive ... faster and more efficiently.About the PositionWe are seeking an Associate Director, Program Management to drive the execution of critical drug development programs… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe ... Quality Systems Lead role is an exempt level position with responsibilities...quality systems processes.Key Responsibilities Provide oversight to the CAPA program for the CAR-T manufacturing site.Oversee metrics, trending, and… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our tech strategy through 0-to-1 ... with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management, and Clinical Operations teams to help identify solutions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role is responsible for developing and implementing effective congress and speaker program strategies and plans to elevate our engagement, corporate presence and ... Functions Strategy, Planning, Performance and Tracking Elevate Portfolio congress, speaker program and market development strategy, plans and execution aligning with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …more patients than ever before. The Position The Rare Disease Marketing Operations Lead is responsible for assisting the Rare Disease Commercial Strategy & Marketing ... will develop and implement a comprehensive strategy for agency management, lead portfolio promotional materials management and drive cycle planning and operations.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance ... of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality Reviews of respective product profile to ensure appropriate… more
- Merck & Co. (Rahway, NJ)
- …Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS ... innovate, iterate, and problem-solve.Cross-Functional Collaboration:-Unite diverse teams to achieve program goals as One Team. Champion compliance and safety;… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Leads, coaches and delivers a holistic, effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation, ... for new hiresOptimizes the effectiveness and efficiency of training program in delivery of qualified personnelSupports investigations and evaluates improvement… more
- Merck & Co. (Rahway, NJ)
- …you will be part of the HHDDA Commercial Data Solutions team and lead Digital Product Management capabilities role, driving shaping and delivery of impactful ... teams to enable use cases across the HHDDA portfolio. In addition, you will also lead a team of highly talented individuals working on multiple data products and use… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical ... development staff.Consults with KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) at the site level to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Finance, Market Access, Legal, and Compliance to establish and monitor the program operations and related forecasts for affordability programs. Works with key ... Trade, Patient Safety and Compliance. External relationships include affordability program vendors. Essential Functions Partners with vendors and oversees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check ... Initiates contact w/KOL and prepares material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due… more
- Merck & Co. (Rahway, NJ)
- …trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff assigned to a development ... and provides biostatistical support for drug projects under the supervision of management.- Lead a team of staff assigned to the project as needed.-This includes… 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 for ... optimization of calibration frequencies through a calibration interval management program including minimally invasive instrumentation tasks which support calibration… more
- Merck & Co. (Rahway, NJ)
- …effective, efficient, and seamless cross-functional collaboration to deliver novel strategic program and study design, analysis strategy, and analysis results with ... statistical techniques and methodologiesMentors team statisticians in developing adaptive program -level statistical strategies, ensuring alignment with rapidly evolving field,… more
- Merck & Co. (Rahway, NJ)
- …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 ... team of approximately 5-10 pharmacometricians to achieve results on major program drivers by identifying and implementing quantitative approaches (for eg,… more
- Merck & Co. (Rahway, NJ)
- …proven talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, ... program risks and mitigation strategies. In-depth knowledge in upstream...ensure the team alignment with functional objectives.Ability to communicate program progress, issues, and mitigation plans to the senior… more
