- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Merck & Co. (Rahway, NJ)
- …team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of ... will:Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.Manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... producing scientifically accurate, high- quality clinical regulatory documents while adhering to...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality ... Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity ... activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer.Drug Development Strategy:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust publication plans for the Therapeutic Area and respective products. Mentor Associate Director Publication leads on publication planning and execution ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Merck & Co. (North Wales, PA)
- Job DescriptionLead and develops the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to ... of safety database.Provide expert guidance on policies and procedures related to quality and compliance of expedited and periodic reports.Interpret FDA and EU… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non- clinical , Medical Affairs, Marketing, Legal, Quality , and other ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... primary accountability for operational study level time, cost and quality deliverables.Lead the development of the clinical ...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory, Operations, Non- clinical , Clinical , and other ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Global RWE & Data Science sought by a pharmaceutical company in Nutley, NJ. Assess ... programs in support of global market access initiatives. Lead clinical meaningfulness initiatives that address issues such as payer...that address issues such as payer challenges, impairments in quality of life and patient well-being, and gaps in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for operational improvements and seek agreement through consensus management.RelationshipsReports to an Associate Director / Director within the NNI ... and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring… more
- The George Washington University (Washington, DC)
- …Summary: The Director , Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP-RIC) and is responsible for leading ... and carries out annual reporting requirements; In collaboration with the Executive Director for Research Integrity and Compliance, oversees quality assurance and… more
- Concorde Career Colleges, Inc. (Aurora, CO)
- Overview Diagnostic Medical Sonography - Director of Clinical EducationOur Mission:At Concorde Healthcare Career College, we are dedicated to making a difference ... and community development. We are seeking a passionate and dedicated Diagnostic Medical Sonography Director of Clinical Education (DCE) to join our team and play… more
- The Armes Family Cancer Care Center (Findlay, OH)
- PURPOSE OF THIS POSITION The Clinical Support Associate is responsible for the smooth and effective operations of the clerical, billing, admission/registration ... of revenues. Collaborates with the Department RNs, Supervisor, Physician and Director . JOB DUTIES/RESPONSIBILITIES Duty 1: Enters all patient demographics, charges… more
- Senior Living Communities (Myrtle Beach, SC)
- …state licensure as a RN in good standing, must be able to work the clinical floor, and focused on providing excellent clinical care. Skilled Nursing and ... regularly transfer information to necessary parties to improve the quality of work and to provide the supervisor with...is delivered on time and is of the highest quality . Assumes responsibility for mistakes. Presents themselves in a… more
