- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will be responsible for ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA… more
- Merck & Co. (Rahway, NJ)
- …to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their ... with more than one indication, formulation or have an external business partner.Coordinates the preparation, submission and follow-up contact with regulatory… 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
- Merck & Co. (North Wales, PA)
- …an Asset team. Our Company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the ... commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Executive Director /Associate Vice… 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)
- …for KOL interactions on a program-based need; Peripheral involvement in Business Development activities for late-stage compounds Involvement with in-licensing ... regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.Responsibilities:Medical… more
- Tris Pharma (Monmouth Junction, NJ)
- …for all safety and PV issues Provides input and expertise to aggregate safety reports (ie, development safety update reports, periodic benefit risk ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director ,...limited to: medical analysis and decision making for the development of ad hoc aggregate safety reports,… more
- Eisai, Inc (Nutley, NJ)
- …Safety processes, such as Case in-take, Case processing, Risk management and Safety reporting; Business Intelligence technologies such as Tableau, Spotfire, ... and oncology, with a strong emphasis on research and development . Our history includes the development of...and planning for IT systems and projects. Partner with business leaders, SMEs to understand how the functions operate… more
- Merck & Co. (Rockville, MD)
- …address regulatory policy issues.- Assignments will evolve over time to meet business objectives and programmatic needs, and Director 's areas of ... team advocates for regulatory policy that supports our company's business goals, developing wider support for our causes and...and most directly with Global Regulatory Affairs and Clinical Safety (GRACS) to define and implement a prioritized plan… more
- Catalent (Harman, WV)
- …customer satisfaction, while optimizing cost effectiveness.Liaise with operations, project managers, business development and clients in all aspects of ... Senior Director , Supply Chain Position Summary: The Senior ...and working capital and concurrently links with finance and business development to ensure a process of… more
- Eisai, Inc (NJ)
- …communication/publication components of overall medical operating plan. The Medical Director provides strategic development , planning, implementation and ... and oncology, with a strong emphasis on research and development . Our history includes the development of...profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand strategy and tactical process with financial analysis as well as liaise with business development and other strategic business cases Reviews and ... information. Serve as an internal consultant for Marketing, Sales, Finance, Supply Chain, Business Development , and Investor Relations on forecasting issues on a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the data services they… 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)
- …Area; Reviews content to be shared with KOLs; Frequent involvement in Business Development activities for late-stage compounds; Involvement with in-licensing and ... for Phase 3 registrational study; Consults with KOLS for advice on complex development or safety issues.Scientific, Program Related: Integrated Study Team (IST)… more
