- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Manager , Operations and Reference Data Management, Global Clinical Data Standards Working closely with the Global ... Clinical Data Standards (GCDS) Sr. Director of Operations and Reference Data Management within the Global Data Management & Standards (GDMS) organization, the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs, as well as cross-functional stakeholders (eg, RA CMC, R&D Excellence, Clinical Operations , IT).Responsibilities Operate within and in support of the ... other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disciplines and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This ... vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs,… more
- Merck & Co. (Rahway, NJ)
- …as needed.Works in partnership with GCTO (Global Clinical Trial Operations ) country operations , finance, regulatory affairs, pharmacovigilance, legal ... Job DescriptionWith support of Sr CRA/CRA Clinical Research Associate) and/or CRA Manager ,...clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC… more
- Merck & Co. (Rahway, NJ)
- …as needed.-Works in partnership with GCTO (Global Clinical Trial Operations ) country operations , finance, regulatory affairs,-pharmacovigilance, legal ... Job DescriptionWith support of Sr CRA ( Clinical Research Associate) and/or CRA Manager ,...Related CR ( Clinical Research) experience may include Clinical Trial-Assistant, Study Coordinator, Regulatory CTC (… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study,-taking overall ... and CRD as needed.Works in partnership internally with GCTO country operations , finance, regulatory affairs,-pharmacovigilance, legal and regional operations… more
- Novo Nordisk Inc. (Los Angeles, CA)
- 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
- 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 ... trials, some of more recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical, biotechnology, CRO, and/or healthcare… more
- Aequor (NJ)
- …and labelling configurations and create packaging specifications in collaboration with Clinical Operations partners. Collaborating with Global Clinical ... during phases 1-4. The individual must partner closely with clinical , regulatory , quality and production associates to...CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure… more
- Integrated Resources, Inc (Foster City, CA)
- …W2. Job Description: Client is currently seeking an industry leader for Sr. Manager , R&D Outsourcing within our Development Business Operations department. The ... clinical outsourcing of global Phase 1b-Phase 3 clinical trials. The Sr. Manager will lead...or high value contracts * Demonstrates strong understanding of regulatory and legal issues pertinent to clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of External Vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing ... diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), ... including experience in one or more key functions (eg, clinical research, clinical operations , data...and metrics dashboarding preferred- Understanding of industry trends (eg, regulatory , technology) with ability to apply them to process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol, Good ... Value process in evaluating study budgets.Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …is required to frequently apply a set of management principles to ensure smooth operations of the department. The Nurse Manager must be capable of independent ... from Charge Nurses, educators, and other nursing support personnel, the Nurse Manager directly supervises the clinical nursing and ancillary personnel assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, 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… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Option Care Health (Bozeman, MT)
- …of the Option Care, current pharmacy practice professional standards, and other regulatory entities. The Pharmacy Manager is responsible for the coordination ... and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health...of all drug products and medical supplies. The Pharmacy Manager is responsible for assisting the Operations … 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
- Northeast Georgia Health System, Inc (Braselton, GA)
- …as they occur. With support from Charge Nurses and Educators, the Nurse Manager directly supervises the clinical nursing and ancillary nursing personnel assigned ... and must exercise sound, independent judgment in adapting and applying leadership and clinical principles to specific situations. The Nurse Manager relies on… more
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