- Merck & Co. (Rahway, NJ)
- … clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be ... commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in… more
- Merck & Co. (Rahway, NJ)
- …commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ... (Principal Scientist)has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines.… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for ... Key responsibilities include: Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic ... creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections… more
- Merck & Co. (Rahway, NJ)
- …, Regulatory , Statistical Programming, Data Management, and our company's Research Laboratories Scientists in designing and analyzing clinical trials, and ... in coordinating the statistical activities for clinical drug/vaccine projects.Interacts with Academic Research Organization (ARO), Contract Research … more
- Merck & Co. (North Wales, PA)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory , Statistical Programming, Data Management and other ... of our company's Research Laboratories Scientists in designing and analyzing ...oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory… more
- Tris Pharma (Monmouth Junction, NJ)
- …resolution, risk mitigation and continuous improvement through strategic partnerships with Clinical Research Organizations (CROs) and vendors across all phases ... opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.The Senior ...Clinical Trial Management experience in a pharmaceutical, biotechnology, clinical research or related industry in positions… more
- Insmed Incorporated (Bridgewater, NJ)
- …purchase orders, payment tracking and process for external parties.Strong knowledge of clinical research process, including working knowledge of all functional ... experience in a Clinical Operations Experience considered relevant includes clinical and/or basic research in a bio/pharmaceutical company, Academic … more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... we want to hear from you. Job Summary The Senior Manager, Translational Science Biostatistics will be expected to...across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development,… more
- Merck & Co. (North Wales, PA)
- …creation of the SDTM deliverables for analysis and reporting and world-wide regulatory application submissions of drug and vaccine clinical development projects. ... Job DescriptionThe Senior Statistical Programmer, Study Data Tabulation Model (SDTM),...with internal and external stakeholders including Statistical Programming, Statistics, Regulatory , Data Management, Clinical and other project… more
- Eisai, Inc (NJ)
- …to obtain all applicable source materialCollaborate with cross functional teams like Clinical Research , Biostatistics, Statistical programming, Clin Ops. etc. to ... related industry OR equivalent combination of education and experienceExperience writing/reviewing clinical regulatory documents and submissions for own area of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of… more
- Eisai, Inc (Nutley, NJ)
- …of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Merck & Co. (Rahway, NJ)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory , Statistical Programming, Data Management, and ... planning, providing guidance to others in the statistical support for clinical drug/vaccine projects.-Interacts with Academic Research Organization (ARO),… more
- Eisai, Inc (NJ)
- …will oversee and lead and support activities related to the outsourcing of clinical services to Clinical Research Organizations (CROs) and functional ... is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines,… more
- Insmed Incorporated (Bridgewater, NJ)
- …contract research organizations.Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on Program ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we...and Clinical / Regulatory strategy.Author nonclinical sections in … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and ... specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and...in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... make a difference. If this is your profile, we want to hear from you. Senior Manager, US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Merck & Co. (North Wales, PA)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial, and other ... Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development organization at our company. Position Description/Summary The … more
