- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of related experience related experience, including IT/system management in Pharmaceutical Development / Clinical research, and Project Management required- 1+ ... and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical trials requiring Clinical… more
- Merck & Co. (Rahway, NJ)
- …systems and capability strategy and to prioritize DSCS Digital efforts. Apply expert project and portfolio management skills effectively, with relatively broad ... and an inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product,… more
- Aequor (Thousand Oaks, CA)
- …authoring, reviewing and defending critical product impacting non-conformances? Experience in Project Management in support of product development ? Knowledge of ... Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The PQL has… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... profile, we want to hear from you.The Associate Director, Strategic Content Development , Global Medical Affairs - Alzheimer's Disease, in the Neurology Business… more
- Merck & Co. (Rahway, NJ)
- …publish (peer-reviewed journals) and patentRepresent BPR&D as an upstream, cell-culture expert in internal, cross-functional project teams and external ... Job DescriptionPosition Description: Principal Scientist, Upstream Bio Process Development BPR&D within our Company's Research Laboratories is on a mission to… more
- Merck & Co. (North Wales, PA)
- …study reports, or publication; andParticipating in internal and joint internal/external research project teams relevant to the development of new compounds and ... Asset team. Our Company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety Input to all activities for Risk Based Monitoring across the development project . Physical Requirements Approximately 10% overnight travel required. ... About the Department Our East Coast Global Development Hub brings together the best minds in...cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …execution in one or more key functions (eg clinical research & development , clinical science, clinical quality assurance, project management) requiredStrong ... management to ensure prevention of issues, early identification of issues, and provide expert advice on identification of root causes and support development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Compliance with Core Data Sheets/Label Changes: Develop and communicate strategic labeling development strategic plan to other project team GLLs and to ... serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an...Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …where applicable, and to ensure timelines and business objectives are met. Subject matter expert (SME) in 2 or more focus areas. May supervise a team of Clinical ... actions, and communication and risk minimization plans.Authors or oversees the development of minimum core product safety requirements for inclusion in Clinical… more
- Merck & Co. (Rahway, NJ)
- …assay validation.Troubleshoot assay and instrument-related issues.Serve as a subject matter expert in flow cytometry by collaborating with project teams, ... Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendors to ensure high quality of coding deliverables to support drug development processes and global submissions. This position provides leadership within Data ... ensures quality delivery of medical coding for clinical trials, clinical development , and regulatory submissions. Develops and proposes strategies for medical coding… more
- Merck & Co. (Boston, MA)
- …including monoclonal antibodies and engineered proteinsClose collaboration with Discovery and Early Development project teams in Boston (MA), South San Francisco ... in Boston, MA.- The ideal candidate will lead PDMB efforts as a project -team representative and PK/PD subject matter expert , regularly interacting with… more
- Merck & Co. (Rahway, NJ)
- …external vendors to define project scope and objectives, develop preliminary project plan and design.Manage and track product development work, especially ... of both internal and external resources located on and offshore; manager project in Agile (Scrum) development methodology; planning, organizing, and conducting… more
- Eisai, Inc (Nutley, NJ)
- …clinical trial setting and observational studies.Serve as the lead statistician on project teams, offer statistical insights into clinical development plans, ... through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably… more
- Merck & Co. (Rahway, NJ)
- …This role is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with International ... and link between Country Operations-and clinical trial team (CTT).Responsible for project management of the assigned studies: pro-actively plans, drives and-tracks… more
- Merck & Co. (Rahway, NJ)
- …(CCQMs) and Associate Country Clinical Quality Managers (ACCQMs) as well as talent development in collaboration with RCQM. -The role requires the ability to properly ... to support continuous improvement initiatives. Advanced skills in strategic thinking, project management, ability to lead during ambiguity, analysis and risk-based… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …minimal-to-no supervision. The Director will work closely with cross-functional project teams, including Clinical Development , Clinical Operations, Biometrics, ... About the Department Our East Coast Global Development Hub brings together the best minds in...a difference?The Position The Director, Medical Writing is an expert in medical writing and performs work independently with… more
- BioAgilytix (Durham, NC)
- …and existing business needs. This position serves as an Automation Expert , ensuring the efficient operation of automated laboratory equipment, conducting ... with cross-functional teams to identify automation opportunities and develop project plans to implement automated solutions to support (GxP) validation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …throughout development and, ideally, post marketing, providing teams with expert advice and/or access to external expertise for novel safety issues requiring ... global pharma innovator in oncology, a therapeutic area known for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and… more
