- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …portal is current.Lead/co-lead global process development and procedural document drafting , as appropriate.If necessary, substitutes for the Director at trial ... disclosure related meetings. Drafting agendas and minutes, leading actions as appropriate and ensuring deliverables are completed on time and within budget.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …types of agreements) in the pharmaceutical and companion diagnostic fields, including drafting , negotiating and reviewing such agreements for US, global and ex-U.S. ... matters.- Provides IP legal support, as needed in negotiating, drafting and reviewing licensing, co-promotion, co-development, co-marketing, clinical trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position, the incumbent will take on organizational responsibilities relevant to drafting global communications for QA, QA projects as assigned, ensuring onboarding ... of N-3 leaders directly reporting to the VP of Quality, and in close collaboration with the QA Training and Documentation management team. This position will take direction from global strategy and operational QA leader, however is also accountable to the VP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functional teams to support the design and execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this ... high visibility position, the candidate will be interfacing with both internal and external stakeholders including KOLs and Principal Investigators. Relationships Reports to: Vice President, Medical & Science. Work with the VP Medical/Scientific Development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Interactions with Healthcare Providers Participating in product lifecycle planning Drafting , reviewing, and negotiating contracts Performing other duties as assigned ... Physical Requirements 0-10% overnight travel required. Qualifications A JD is required. A state bar admission is required 4+ years of legal experience preferred Experience within the healthcare/pharmaceutical industry (including experience with FDA,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …invention disclosure tracking, review, and evaluation- Drafts and/or assists in the drafting of IP-related documents for filing with the US Patent and Trademark ... Office (USPTO)- Monitors status and needs throughout all phases of the patent prosecution process- Maintains internal and external IP reporting sites, including patent marking and trademark lists- Prepares IP docket reports and other IP portfolio reports.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …monitoring findings are discussed with Compliance leadership, assist in drafting email reminders, training bulletins, and relevant training module creation.Work ... with the various business functions across the business to design and review business-led monitoring activities as part of their overall responsibilities and, if required, assist in developing reporting tools so that CM can receive monthly updates on the… more
- Insmed Incorporated (Bridgewater, NJ)
- …be responsible for managing key aspects of the Company's patent portfolio, drafting patent applications, providing advice on prosecution strategy, and IP due ... diligence activities. The role may include a hybrid schedule for the right candidate.ResponsibilitiesProactively work with the research and clinical teams to identify inventions and to draft invention disclosures.Attends R&D meetings and patent review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preclinical through Phase 3 and 4.- CRO / Vendor Oversight: Participates in drafting request for proposal for CRO selection. Reviews and negotiates baseline budget ... and timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results. Ensures timely delivery of high… more
- BioAgilytix (Durham, NC)
- …validation and implementation, including protocol/throughput analysis; instrumentation specification; drafting user requirements; validation plans, test scripts and ... validation summary reports.Lead programming of automation systemsServe as the primary point of contact and Automation Expert for all automated laboratory equipment.May interact with Business Development to create appropriate scope for automated… more
