- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide high ... input into development plans, study designs, and regulatory submissions. The Director will provide direction...measurements that are consistent with the priorities of the business , and that interim reviews are held so that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulatory activities Lead the ... advanced degree is strongly preferred Minimum of 10 years drug development /FDA/ regulatory related industry experience required Demonstrated knowledge of global… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements Work with the VP Medical/Scientific Development , Clinical ... develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support...regulatory authorities, as appropriate, in support of the development objectives for DCR-PHXC and assist Regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and China, and indirect accountability for JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and implementation ... these findings to relevant cross-functional stakeholders, to help inform future DS regulatory / development strategies, activities and ways of working. This role… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within ... of clinical trials is required Demonstrates technical expertise within Clinical Development , Medical Affairs, and Regulatory Affairs (CMR), staying up-to-date… 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 ... maintaining our facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will have the opportunity to build… more
- Tris Pharma (Monmouth Junction, NJ)
- …planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development , Regulatory Affairs, Manufacturing, Quality, etc. to identify, ... potential risks mitigation, etc. Collaborates with appropriate clinical, medical, quality and regulatory counterparts and others across business to provide input… 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 ... multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS)...transition of rising star early assets to late phase development , based on the vision for the functionAs the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulators/ industry experts and align develop the CSPV road map to meet changing regulatory and business needs.Assure a closed loop of PV risks identified ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...and strategic quality advice to the CSPV and key business function and collaborate with RD and Medical Affairs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sites. These business functions include: Clinical Operations, Clinical Development , Biostatistics and Data Management, Regulatory Affairs, Quantitative ... around rare diseases and immune disorders. Summary Deliver the development and implementation of Research & Development ... (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS) in the US,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and ... Operations and ensure an organized approach- Onboarding support: Coordinate QA on boarding business training with New Hire and ensure New Hire has a sufficient… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …will manage, with limited direction, end-to-end delivery of AI/ML projects (from business understanding, over hands-on development to dissemination), to ensure ... - 7 or more years of professional experience in data science / business intelligence / statistics role supporting drug development and/or post marketing… 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 ... creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards, (v) encouraging innovation.Build strong relationships with clinical development , clinical sciences, regulatory , biostats, data management, ... required- Proven global line management expertise; experience of performance management and development of Director + level staff required- Proven experience in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direction and future investments- Contributes to portfolio, in-licensing and relevant business development Qualifications: Successful candidates will be able to ... purpose of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices),… more
