- Eisai, Inc (Philadelphia, PA)
- …difference. If this is your profile, we want to hear from you. The Associate Director of Global Submission Management (GSM) is responsible for leading, ... processes to ensure submission timelines are met regardless of the region.The Associate Director , Global Submission Management (GSM, is responsible for the… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Global Associate Director , will lead projects and contribute to the payer evidence strategy ... to complete analyses while proactively providing updates to the project team and according to timelines and requirements. The...Transparency Language:The annual base salary range for the Associate Director , Global Value & Access is from… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , Technical Operations within Global Clinical Supply (GCS) is responsible for technical leadership in support of GCS global ... equipment-based challenges when required.- The technical lead may also manage global infrastructure projects to establish, upgrade, and improve the GCS packaging,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needs of the overall development plan agreed to by the Global Project Team (GPT). People and Resource Management :Develops talent through providing focused ... their management to share lessons learned and best practices across the Study Management Organization. The Director can serve as an SDL at early stages… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership ... and strategic direction for the clinical project management functions in a technology-driven, AI-focused biotech environment. This individual will be responsible… more
- Eisai, Inc (Bethesda, OH)
- …to apply regulatory guidelines pertaining to product labeling and ICH guidelines.Strong project management , people management , problem solving, strategic ... your profile, we want to hear from you. The Director , Global Labeling is responsible for the...labeling of pharmaceutical products globally, and serves as the global regulatory labeling representative on relevant project … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management Process for the respective business areas.Responsibilities:Leadership and Project Management :Lead the end-to-end quality execution across Medical ... Director , Medical Affairs QA as needed. Cross-functional and Global Team Participation:Drive quality excellence through effective business partnerships with… more
- Eisai, Inc (Nutley, NJ)
- …of the Drug Development process and working with cross functional international/ global project teams.Position has both direct and indirect reports ... your profile, we want to hear from you. The Director , Global Regulatory, Growth Markets will be...Director will manage regulatory submissions, registrations, and lifecycle management activities for new and existing products in these… more
- Merck & Co. (Rahway, NJ)
- …and other teams and the ability to successfully work across geographic boundaries. Project management , including the ability to adapt to changing priorities ... Cross-Functional Teamwork, Detail-Oriented, Name Development, Process Improvements, Professional Presentation, Project Management , Regulatory Compliance, Strategic PlanningPreferred Skills:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for pharma and/or biotech companies preferred4 or More Years Experience managing project delivery in global and/or multicultural collaboration preferred4 or More ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Canada, United States and Japan and may include other regions/ management units as needed to reflect changes to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other departments to ... , Clinical Safety, will lead the development and implementation of integrated project /product risk management strategies aimed at achieving the optimum… more
- Insmed Incorporated (NJ)
- …and/or leadership experience in R&D and commercial in a biotech/bio-pharmaceutical environment. Project Management Professional (PMP) certification a plus but not ... objectivesAs the strategy evolves, prepare alternative development and risk management scenarios, project updates and options and...teams to meet or exceed goals by providing superior global cross-functional leadership and management in a… more
- Insmed Incorporated (NJ)
- …development for assigned programs. This role will provide regulatory input to global cross-functional project teams throughout product development and submission ... global regulatory strategies for clinical, pre-clinical, and lifecycle management activities for assigned programsIdentify and assess regulatory risks associated… more
- Merck & Co. (North Wales, PA)
- …years pharmaceutical business experience, including marketing, sales, and/or operations Excellent project planning & management skills; strong analytical and ... Job Description Director , US Oncology Marketing, INT Treatment Site Strategy...intismeran autogene treatment process, including but not limited to global orchestration lead, manufacturing, supply chain, IT, legal/compliance, market… more
- Texas Childrens Hospital (Houston, TX)
- We're searching for a Director of Nursing - Emergency Center & Clinical Support Services, someone who works well in a fast-paced setting. In this position, you'll ... System Lead operational team in the Emergency Center during a multi-phase construction project to grow the physical footprint of the EC Collaboration with leaders… more
- Eisai, Inc (WA)
- …projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. ... trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Job Description Summary We are seeking a… more
- Eisai, Inc (Nutley, NJ)
- …Senior Director of Clinical Outsourcing provides strategic leadership for global outsourcing and vendor management activities within clinical development. ... performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance frameworks, and compliance with ICH/GCP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contracts add value to the organization (cost, quality, timelines). Take ownership and project manage vendor contracts, change orders and work with the Vendor and… more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Director of Clinical Outsourcing is responsible for leading the development and execution of ... as a key liaison across internal teams and external partners, the Director drives operational excellence, risk mitigation, and inspection readiness while fostering… more
- Merck & Co. (Rahway, NJ)
- …and international environments.- Excellent communication, stakeholder engagement, and project management skills. Preferred: Experience with other ... Job Description Associate Director , Regulatory Submissions Archive Operations - Location: Rahway,...week required) - Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs &… more
