- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust… more
- Merck & Co. (Rahway, NJ)
- …ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions. Lead the Device ... with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Merck & Co. (Rahway, NJ)
- …technical solutions with the highest value, that improves the way we run our clinical trials for our patients, our partners, and our employees.Candidate will have a ... Office (PMO) for one of our Company's Enterprise-wide Accelerate multiyear program , that focuses on technology and process transformation, simplification and… more
- Merck & Co. (Rahway, NJ)
- …hypothesis-based assessment employing a rigorous integrated approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical ... and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build... with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong… more
- Merck & Co. (Rahway, NJ)
- …a distinguished department within our Company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter ... state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing, and marketing of medical drugs and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and recruitment process, relationship management, training activities, and management metrics Lead development of commercial readiness strategy and oversees ... programs, and overseeing the management of speaker and HCP program operations and technology systems. This position will also... operations and technology systems. This position will also lead the development of operational business plans… 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 ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... with the Global Team leader as the Project Management lead on drug development projects. This position... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …up-to-date on changes and related needs for patient support Develops recommendations and lead team to implements program changes to ensure ongoing compliance, ... reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional Medical Safety collaborations within and across line functions, eg Clinical Development , Medical Affairs, Regulatory Affairs, Clinical ... external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Medical, Clinical Development , Clinical Scientists, Clinical Safety and Pharmacovigilance and Biostatistics program teams to meet needs of ... for delivery of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and contribute to improved patient outcomes and experiences. Essential Functions Educational Program Strategy : Lead the development of comprehensive ... and therapeutic area strategies. Collaborate with KOLs and other clinical stakeholders as well as sales and marketing leadership...for educator team. Education Content Development : Lead the development of educational program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of technical training across all CMR functions, and compliance across clinical development , medical, and regulatory roles/processes/SOPs Develop and implement ... development , effective execution of CMR role-specific/technical training (eg clinical trial-related, patient safety, therapeutic area leads, MSLs etc.) across… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …record in executing effective project management in cross-functional drug development teams or clinical , regulatory, pharmaceutical sciences/technical operations ... for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… 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 ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...ready to make a difference? The Position Serve as lead for CRM (customer relationship management) system supporting NNI… more
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Title:** Clinical Development Program Lead , Hematology **Position ... Description:** The Clinical Development Program Leader (CDPL), Hematology sits within Clinical ...overall portfolio view + Provide strategic insights into the clinical development plans + Lead … more
- Novo Nordisk (Plainsboro, NJ)
- …KOLs and Principal Investigators. Essential Functions + Support the ALD clinical development program as medical lead and expert drug developer, providing ... the Senior International Medical Director will be the medical lead for clinical development of...Disease department. Work with the Clinical Operations, Non- Clinical Research, Medical Writing, Program Management, CMC… more
