- 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
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… more
- Eisai, Inc (Nutley, NJ)
- …communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning , implementation and ... If this is your profile, we want to hear from you.The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director , Omnichannel Marketing and Media position reports to the Senior Director , Omnichannel ... deliver omnichannel and media specific marketing input and activities.The Associate Director of Omnichannel Marketing and Media is responsible for managing,… more
- Eisai, Inc (Nutley, NJ)
- …Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This role is ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning , implementation, and… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you.Accountable for the strategy, prioritization and planning for IT systems and projects. Partner with business leaders, SMEs to ... security and/or corporate systems' roadmaps. Collaborate with global finance for the planning , approval and reporting of budgets and forecasts. Lead the definition… more
- Merck & Co. (Rahway, NJ)
- …the company as needed (including Senior Executives) and working closely with Regulatory , Legal, Manufacturing, Technical Transfer, Supply Planning and Global ... Job DescriptionCompanion Animal Global Marketing - Director , Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development and… more
- Merck & Co. (Rahway, NJ)
- …innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI) ... the identification and prioritization of intelligence efforts critical to strategic planning and execution for key stakeholders and will provide direction for… more
- Merck & Co. (Rahway, NJ)
- …on alliance global brand team, joint product development team, and joint regulatory / labeling discussionsSupport alliance forecasting and scenario planning by ... Job DescriptionWe have an exciting Director opportunity to join our global oncology marketing team focusing on co-commercialization of an Antibody Drug Conjugate a… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of… more
- Merck & Co. (Rahway, NJ)
- …cancer patients globally.We are currently seeking an Oncology Competitive Intelligence Director specializing in Women's Cancers. This role is responsible for ... comprehensive understanding of relevant healthcare environment matters, including policy, regulatory , and health technology.Developing a global internal network of… 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)
- …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
- 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)
- …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 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)
- …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)
- …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
- 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
