- Merck & Co. (Rahway, NJ)
- … Clinical Research Associate - Northeast Region (Remote) With support of Senior Clinical Research Associate (SrCRA/CRA) and/or CRA Manager, acts as ... contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated... research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC… 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)
- …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
- 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
- Merck & Co. (North Wales, PA)
- … clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may ... talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of ... university)PhD in pharmacology or pharmaceutical sciences or PharmD with a clinical pharmacology research fellowship required Experience Qualifications7 or more… more
- Lundbeck (Bothell, WA)
- …to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding of ... to the position is a thorough understanding of the regulatory and industry standards that are required for potency...for all development programs (from early to late phase clinical development) Author and review SOPs, development reports, and… more
- Merck & Co. (Rahway, NJ)
- …strategies with corporate goals and providing critical therapeutic area insights.Recognized clinical research expert in areas such as atherosclerosis, ... Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be… 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
- 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 (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)
- …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
- 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
- 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. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees typically… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research , ICH GCP Principles and the application of those ... About the Department The Clinical , Medical and Regulatory (CMR) department... Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
