- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide ... high level strategic input into development plans, study designs, and regulatory submissions. The Director will provide direction and mentoring to other members… 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)
- …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)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... programsThe CS group lead will also contribute to the program study strategy, planning , execution, and reporting outputs in collaboration with the CS Asset LeadsThe… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …presentation, meeting agenda and meeting minutes.- May be delegated for logistic planning and coordinating the QA Meeting which including the QA leadership meeting, ... projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and… 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
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate with ... clinical study conduct; Collaborates closely with internal stakeholders, (ie Regulatory Affairs, Product Development, Research and Development (R&D), Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this workPossesses in-depth ... knowledge of regulatory authority's requirementsTypically has administrative responsibility for recruiting, retaining,...support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as… 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)
- …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
- 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)
- …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)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining,...support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and ... planning , review Case Report Form (CRF) annotation and SDTM...quality and integrity.- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial, clinical… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning , directing, coordinating and prioritizing ... periodic safety reports, signal detection activities and risk management planning . The incumbent works cross-functionally with counterparts/teams in Clinical… 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
