- Merck & Co. (Rahway, NJ)
- …Development, Stakeholder Engagement, Stakeholder Relationship Management, Strategic Planning, System Designs, Systems Development Lifecycle (SDLC)Preferred ... more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... activities that encompasses the internal systems and processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support,… more
- Eisai, Inc (Nutley, NJ)
- …team in terms of application design, development, validationGood understanding in Clinical Data Management Systems & standards, eg, InForm, relational ... Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation.Strong organizational skills with ability to effectively manage and… more
- Merck & Co. (San Francisco, CA)
- …Director, DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will ... robustness across organizational deliverables.- In this role, the DSCS Digital Project Manager will provide tactical direction and partner with the DSCS Digital… more
- Merck & Co. (North Wales, PA)
- …DescriptionThis position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have ... management, communication, and collaboration skills in support of our clinical trials.Job Responsibilities: Responsible for the operational planning, feasibility,… 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 ... and leverages relationships with HQ SMEs, process management, and system management to influence process and system ...and system management to influence process and system development in a manner consistent with global affiliate… 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 ... and upholding processes anchored in the NN Quality Management System (QMS) across NAO thereby ensuring highest quality to...and leverages relationships with HQ SMEs, process management, and system management to influence process and system … more
- Lundbeck (Fort Wayne, IN)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... by providing comprehensive clinical knowledge, executing sales and marketing strategies in the...with high influence customers in physician clinics, integrated health systems , infusion centers and alternative sites of care Product… 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 ... and leverages relationships with HQ SMEs, process management, and system management to influence process and system ...and system management to influence process and system development in a manner consistent with global affiliate… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings with ... and inspection readiness activities. Provide input for re mediating PV system deficiencies cited in audit/inspections. Manage the implementation of effective… more
- Daiichi Sankyo, Inc. (Winston-Salem, NC)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product, and its approved indications,...hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence… more
- Daiichi Sankyo, Inc. (New York, NY)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product, and its approved indications,...hospitals, and community practices).Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to...include new ways of working with existing or new systems (eg, Vault RIM)Work with GRA stakeholders to define… more
- Merck & Co. (Rahway, NJ)
- …review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance in support of ... our company's clinical supply programs. This person will also independently review...audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard… more
- Merck & Co. (Rahway, NJ)
- …Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility supports the formulation and filling ... of clinical and developmental supplies for sterile products, including critical...and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.-… more
- Novo Nordisk Inc. (Orlando, FL)
- …The EDCS must achieve sales goals by utilizing a patient-centric and clinical approach to engaging their customers and promoting Novo Nordisks portfolio of ... assess, create and maintain advocacy of customers aligned to company, brand and clinical goals; the EDCS develops local strategies and executes local tactical plans… more
- Novo Nordisk Inc. (Walnut Creek, CA)
- …ability Ability to navigate PA's in rapidly developing market Health Systems and/or Institutional Account experience is preferred Clinical approach ... in health care settings and major academic and large community health systems . The Specialty Field Sales Representative also assists their target physicians with… more
- Novo Nordisk Inc. (Boston, MA)
- …Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders. ... Internally, the Ecosystem Portfolio Specialist reports to the Ecosystem Business Manager . The Ecosystem Portfolio Specialist also must work collaboratively work with… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
