- Merck & Co. (Rahway, NJ)
- …execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre- ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist)...has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …A minimum of 5 years' experience required (Pharmaceutical industry, laboratory, or clinical research experience) An intermediate to advanced proficiency in ... About the Department The Clinical , Medical and Regulatory (CMR) department...other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director. Works with personnel… more
- Merck & Co. (North Wales, PA)
- …for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer: ... Job DescriptionPosition Description: Senior Medical Writer The Senior Medical...Demonstrates independence in preparing clinical regulatory documents (eg, protocols, clinical study reports,… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis is an ... oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence...and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items… 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
- 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
