- Merck & Co. (Rahway, NJ)
- …Material(s):n/aRequired Skills:Adaptability, Adaptability, Business, Business Risks, Change Management, Clinical Development, Clinical Research , ... Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's Research & Development… more
- Merck & Co. (Rahway, NJ)
- …managing the 'end-to-end' integrated clinical supply chain across the full c ompany's Research & Development Division portfolio of clinical trial s .- GCS is ... within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM).... - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible...Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to… more
- Merck & Co. (North Wales, PA)
- …and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability ... (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection...Adaptability, Clinical Data, Clinical Operations, Clinical Outcomes, Clinical Research , … more
- Merck & Co. (Rahway, NJ)
- …tactical/scientific mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP ... . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data... Clinical Data, Clinical Data Interpretation, Clinical Operations, Clinical Research , … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary: This position manages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety, pharmacovigilance Must have proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials. Ability to ... is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The … more
- Merck & Co. (North Wales, PA)
- …for managing any study specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to ... Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Adaptability, Clinical Data, Clinical Operations, Clinical Research , Clinical… more
- Merck & Co. (North Wales, PA)
- …collaborations, and key strategic engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) ... the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relationships with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical … more
- Merck & Co. (North Wales, PA)
- …Vice President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and ... Job DescriptionIn Biostatistics and Research Decision Sciences (BARDS), a distinguished department within our renowned Research and Development division,… more
- BioAgilytix (Durham, NC)
- …is seeking a Scientist III to serve as Bioanalytical Project Manager (BPM)/Principal Investigator (PI), overseeing all aspects of bioanalytical studies-including ... we tackle challenges across the spectrum of drug discovery to clinical diagnostics, driving advancements that shape the future of healthcare.Essential… 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: The Senior ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… 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, ... speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …knowledge of current regulations, regulatory guidance and or local policies + Assists Clinical research Manager with regulatory based training and ... direction of the Principal Investigator(s), Regulatory Operations Manager and / or directly for the Clinical...the regulatory requirements of the GYN Oncology clinical research project. The RC coordinates aspects… more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager , the Regulatory Affairs ... and wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B (Abramson Cancer Center) Job Profile Title… more
- University of Miami (Miami, FL)
- …Clinical Research Services (CRS) department and is hiring for multiple clinical research and regulatory professional positions. CRS is Sylvester's ... within six (6) months of hire. 4 years of Clinical Research experience is required Regulatory...Regulatory Affairs or related field 3 Years of Regulatory experience is required Manager , Research… more
- Queen's Health System (Honolulu, HI)
- …responsible for organizing, implementing and coordinating multiple clinical research protocols/activities in accordance with all regulatory requirements. II. ... years recent nursing experience in an acute care facility. * Previous clinical research experience preferred. * Experience to demonstrated strong communication… more
- Boston University (Boston, MA)
- **HUMAN RESEARCH QUALITY MANAGER , School of Medicine, Clinical Research ** **Job Description** **HUMAN RESEARCH QUALITY MANAGER , School of ... will provide assistance to clinical researchers regarding regulatory aspects to the conduct of research ...will work with the CRRO Regulatory Education Manager and others within the Human Research … more
