- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... internal stakeholders through the integration of primary market research and secondary data analytics. Incumbent must have the knowledge and technical skills to do… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position The Associate Director of Enterprise Functions Insights & Analytics will provide holistic, ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for ... Data Collection methods, Codelist / Dictionary Managements including Non-CRF Data Mappings (ex: External Data ) for data submissions and relative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Surveys, distill insights and Socialize Outputs. Seek opportunities to secure new external data drive partnership with vendors in this spaceCollaboration Partner ... Catalog along with strategy for End User Education and Dashboards adoption. External Benchmarking Competitive Intelligence. Leverage public source data (Citeline… 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)
- …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)
- …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)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... of submissions and identify deficiencies against regulatory guidance's or internal data bases.- Facilitate and support liaison activities with functional groups… 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 ... disorders. Summary Position manages the end-to-end delivery of medical coding data for assigned projects/studies collaborating with clinical and medical teams, CROs… 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
- 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)
- …minutes, and communicate materials, in support of the PSL. Independently evaluates safety data of any source to identify potential safety signals and performs safety ... development of the Safety Management Plan for assigned product(s)Independently evaluates safety data of any source to identify potential safety signals and performs… 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)
- …content as required. Send periodic alerts to teams to ensure that shared point data is current and accurate- In collaboration with Head, Global QA Strategy and ... and a wide array of audiences- Edits and produces advanced internal and external communications; acts on behalf of an executive for certain decisions or activities… 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)
- …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
- 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
- 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)
- …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
