- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary The Director , Head of Global Dossier Planning , Regulatory Operations is responsible for leading the dossier planning ... major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions...in all regions. The Director of Dossier Planning will report to Head of Global Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures regulatory strategies adhere to ... external direct/indirect reports. This position pro-actively reviews and interprets regulatory guidelines with respect to impact development programs. Additionally,… 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
- 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)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key… 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
- 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)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will ... The CS group lead will also contribute to the program study strategy, planning , execution, and reporting outputs in collaboration with the CS Asset Leads. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include ... patient support programs data strategy aligns with organizational goals and regulatory requirements, working closely with key stakeholders to drive impactful change… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicable.Study Planning and Execution: As CSL ... Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Executive Management and Board of Directors. Relationships Reports to the Sr Director Omnichannel Engagement. Responsible for the management of a media team that ... with Procurement, Commercial Insights and Analytics (CI&A), Market Access, Regulatory , Sales and Legal personnel, and international colleagues. External… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include ... commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs, Government Affairs &… 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)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …testing new/future opportunities. Relationships This position reports into the Sr. Director , Omnichannel Engagement and is responsible for managing the Consumer ... best practices and technology Champions the Omnichannel Strategy and digital marketing planning process, its outcome and ongoing results on behalf of brand… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has leadership and ... teams reporting into this role must ensure robust strategic and operational planning has been incorporated throughout the governance process, to oversee delivery of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning , regulatory guidance, and in-licensing and has managerial experience. ... to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures efficient… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts ... in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the compound will be… more
