- Merck & Co. (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... performance against metric targets.Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own.Lead… more
- Merck & Co. (Rahway, NJ)
- …(Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. ... study reports, or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds,… more
- Merck & Co. (Rahway, NJ)
- …(Principal Scientist) has primary responsibility for planning and directing clinical research activities involving investigational compounds in Immunology. ... clinical study reports, or publication;Participation in internal and joint internal/external research project teams relevant to the development of new… more
- Merck & Co. (North Wales, PA)
- …(Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... study reports, or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds,… more
- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research… more
- Novo Nordisk Inc. (Irvine, CA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriateness throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... corporate goals, and regional regulatory requirements/precedence.Represent Daiichi Sankyo's regulatory group in internal and external development project … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, ... and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary...governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good ... clinical trial management, with firsthand experience managing collaborative research studies being highly desirable. Responsibilities:Lifecycle Management: Oversee and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and Pop ... PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological...all phases of studies and participates in KOL and regulatory interactions at a project level, and… more
- Merck & Co. (North Wales, PA)
- …Vice President (AVP) has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs for oncology ... clinical study reports, or publicationParticipation in internal and joint internal/external research project teams relevant to the development of new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical … more
- Merck & Co. (Rahway, NJ)
- …and key strategic engagements. This includes the ability to:Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage ... the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of ... key submission documents; Point of contact for interactions with regulatory -agency clinical reviewing divisions on clinical... reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of ... key submission documents; Point of contact for interactions with regulatory -agency clinical reviewing divisions on clinical... reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Merck & Co. (North Wales, PA)
- …Experience and Skills:Minimum of 8+ years' experience in Ophthalmology clinical research . Prior industry experience strongly preferred.Substantial experience ... input into research and business development priorities and prioritization of clinical assets.-May serve as the senior liaison for relevant stakeholders in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study Strategy: Provides… more
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