- Merck & Co. (Rahway, NJ)
- …the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... writing, and presentation skillsEducation/ExperienceBachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical… more
- Merck & Co. (Rahway, NJ)
- …GSE Safety & Environmental Standards and Guidelines SAP Training and skills - Project Manager (PM) role, SAP Plant Maintenance Experience with ProCal as ... DescriptionThis Engineer Senior Specialist (P3) position will provide compliance project engineering-leadership for the Rahway, NJ FLEx (Formulation, Laboratory &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. Summary This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position develops ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study...with Data Management, establish the EDC strategy at the project and/or study level. Proactively identifies and manages risks… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... rare diseases and immune disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Merck & Co. (Rahway, NJ)
- …forces, testing new systems, and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower ... At our company, we're shaping the future of health. We're seeking a Clinical Database Developer who will be instrumental in creating and developing clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or related role in a biotech or pharmaceutical companyDemonstrated success as a project manager /leader in planning and executing strategies for global drug ... rare diseases and immune disorders.SummaryThis position is responsible for providing project management, drug development expertise to Global Project Teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling...updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label… more
- Merck & Co. (Rahway, NJ)
- …a new multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with ... intermediates, liquid suspension/bottle fills, and autoinjector assembly. This team produces clinical and development drug product batches in a GMP piloting facility… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: Manager , Sales Training and Development - Oncology serves as the training subject ... coaching for progressive skills development; Assessing and training product knowledge and clinical selling; Teaching and coaching managed care overview, as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… 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 ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …program. Additional key internal relationships may include MA management, MA project management, Medical Communications, Clinical Trial Management, Clinical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new… 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 ... developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity… more
- The Mount Sinai Health System (New York, NY)
- …audience + Project management of CAPC projects related to online clinical education courses and learning tools, including: + Coordinating working groups ... clinicians provide compassionate and equitable, multidisciplinary palliative care. This Project Manager position is part of a...care leaders to identify best practices in palliative care clinical practice; and the Clinical Education… more
- Hackensack Meridian Health (Hackensack, NJ)
- …to transform healthcare and serve as a leader of positive change. The ** Project Manager , Clinical Trials** develops and implements comprehensive workflows ... Research Program or Division. **Responsibilities** A day in the life of a ** Project Manager , Clinical Trials** at Hackensack Meridian _Health_ includes:… more
- The Mount Sinai Health System (New York, NY)
- …to obtain timely project and protocol approvals. + Work closely with Clinical Trials Manager and provide the project teams with regulatory ... of regulatory submissions and design and works with the Clinical Trials manager to implement improvements in...relationships with IRB staff. + Provide regulatory expertise to clinical project teams (importation of clinical… more
- The Mount Sinai Health System (New York, NY)
- …support from a program management perspective for the improvement of quality, operational or clinical effectiveness. The Project Manager III focuses on new ... **JOB DESCRIPTION** The Project Manager III (AKA Senior ...team interactions and deadlines. 8. Adheres and assists with clinical operations and project specific quality documents… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
