- Novo Nordisk Inc. (Plainsboro, NJ)
- …Act), and within defined budgeting guidance). Relationships Reports to the Executive Director OED. Accountable for managing relationships with external partners ... a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management: Build strong internal and external … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... The Position Responsible for the development and execution of data strategies for patient support program use cases and...optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …time and within budget. The position holder will partner with internal and external stakeholders as well as vendors to optimize AI/ML technology, processes and ... best practices as well as strong technical skills in working with (clinical) data . The position holder will require strong skills in continuous improvement, project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... the portfolio of compounds within Oncology/Immuno-Oncology. This position requires internal/ external cross-functional collaboration to develop and apply QSP models… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...medical information and internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders Relationships This position reports to an Associate Director overseeing the contract management function of the CMR ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...and strategic partnership contracting agreements. In collaboration with the Associate Director , the Associate Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leads and Regulatory Liasions to ensure sucessful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of ... while keeping abreast of regulatory and policy updates in the external environment and by tracking and understanding the competitive landscape Qualifications:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders ... in audits and inspections.Operational Efficiency / Continuous Improvement:Provides leadership within Data Management by partnering with internal and external … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global PV Quality teams located in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigational and commercial drugs to the sites of manufacture, both internal and external to Daiichi Sankyo, until completion of the first CPV. The candidate is ... Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects. Serve as the main interface to internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data ... appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the assets are easily accessible and properly utilized. Relationships Reports to the Associate Director of Content Management; Provides direct support to the ... teams, IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors and agencies. Essential Functions Drive metadata and taxonomy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …platform provides a seamless user experience for customers. Relationships Reports to the Associate Director of Content Management; Provides direct support to the ... IT, Regulatory and Commercial Insights & Analytic, as well as external operational vendors and agencies. Essential Functions Investigate user experience design… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part ... and implements changes/ improvements and ensures continuity amongst sites and external CMO partners Drives plans and technology integration for facility… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HEOR is a significant contributor to the development ... and communication of HEOR evidence to demonstrate the value of Insmed's product(s). The Associate Director will work closely with HEOR team members and others… more
- Amicus Therapeutics (Princeton, NJ)
- Associate Director , External Quality Lead (Small Molecule) Location Princeton, NJ Requisition ID 2258 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1303) Associate Director , External Quality Lead (Small Molecule)… more
