- Novo Nordisk Inc. (Plainsboro, NJ)
- …company and clinical site investigators and KOLs Interface together with VP Medical/Scientific Development with Safety Review Committees and Data Safety ... About the Department Our East Coast Global Development Hub brings together the best minds in...develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works closely across ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development . Title and salary commensurate with ... privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety actions, and communication and risk minimization plans.Authors or oversees the development of minimum core product safety requirements for inclusion in ... submission dossier, where applicable, and to ensure timelines and business objectives are met. Subject matter expert (SME) in...Consent Forms (ICFs), for assigned product(s)Authors or oversees the development of the Safety Management Plan for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) Functional ... More Years 7-10 years of relevant project management, process improvement, tools development , business analyses or consulting experiencerequired and - Prior work… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will be responsible for managing ... the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible… 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 strategic quality advice to the CSPV and key business function and collaborate with RD and Medical Affairs...with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As part of leading Regulatory Intelligence, this role will lead the development and implementation of a global approach (incl. processes, roles & responsibilities, ... information into actionable insights, as they relate to DS's portfolio of development and marketed assets, and synthesize and communicate these findings to relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development , Biostatistics and Data ... areas centered around rare diseases and immune disorders. Summary Deliver the development and implementation of Research & Development (R&D) informatics systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Area; Reviews content to be shared with KEEs; Frequent involvement in Business Development activities for late stage compounds; Involvement with in-licensing ... for Phase 3 registrational study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST)… more
- Catalent (New York, NY)
- …This will be a remote, field-based role. Travel is required to support business development activities.The Role Overall responsibility to manage the business ... Account Director , Biologics Drug Substance Catalent Biologics is a...closing of new deals. Identify, open, lead and close business development deals with new and existing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works closely across ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and operational activities as part of the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance ... support of these objectives. This position will report to the Sr. Director , Management Office & Business Excellence in CSPV.ResponsibilitiesProject Management:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …our products. The Finance and Operations team works closely with the business across the organization to guide enterprise wide resource allocations, investment ... while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works closely across ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and are equally important. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, ... is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of other organizations and internal partners to enhance the understanding of business development opportunities offered by data science organization.- Build ... specific focus on infrastructure, budget and non project initiatives. The Senior Director , Global Head of CR2 Project Management & Operational Excellence is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data governance effort by providing data stewardship guidance across the business functions including advocating for good data governance, stewardship, data ... identification, and data quality to enable business outcomes. This role will consist of these components including: Expand and lead our Data Stewardship Working… more
