- Merck & Co. (Rahway, NJ)
- …Document Control Systems, Electronic Common Technical Document (eCTD), Ethical Compliance, Global Health, Global Program Development, High Performance ... Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research… more
- Merck & Co. (Rahway, NJ)
- …global medical communications processes, and demonstrated ability to lead and implement large-scale transformation initiatives1.Prior experience working across ... Job DescriptionThe Director, Global Scientific and Value Content-Healthcare Professional (Dir GSVC-HCP)...role reports directly to the Therapeutic Area (TA) Team Lead , GSVC. The role has several key responsibilities with… more
- Merck & Co. (Rahway, NJ)
- …and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide ... Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our company's Research...reports to the Clinical Supply Q uality Systems Strategy Lead , within CQMS . This role supports the… more
- Merck & Co. (Rahway, NJ)
- …for pediatric vaccines in the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of development therefore ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for ... GCTO country operations.Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is… more
- Eisai, Inc (Nutley, NJ)
- …reports, education, and needs.Essential Functions Advance Medical and Scientific Knowledge of the Global Medical Team (45%) Lead Global MSL continuing ... statistics, etc.) to supplement MSL development.Collaborate with Digital Strategy & Innovation lead on global MSL insights sharing forums. Collate, prepare, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …enterprise IT strategy.ResponsibilitiesStrategic Leadership, Platform management and Governance:Implement and lead the global strategy for process automation, ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …directly and indirectly internal and external associates dedicated to our programs . Lead special projects and assignments as needed.Create thriving and ... its customers, and shareholders. The scope of this group includes strategic program management, enterprise strategic planning, risk management, as well as strategic… more
- Merck & Co. (Rahway, NJ)
- …assets and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs , early clinical development plans for Preclinical ... global clinical trials operations)Provide clinical pharmacology support for programs through the worldwide marketing application filing including supportive… more
- Merck & Co. (Rahway, NJ)
- …Product Line. Come and join our journey to innovate and connect with our global partners to enable end to end visibility of our products ensuring our Company ... compliant supply to our patients. In this pivotal role, you will lead the charge in enhancing our External Manufacturing Digital Capabilities, collaborating closely… more
- Merck & Co. (Rahway, NJ)
- …injectables; pre-filled syringes and/or autoinjectors. -- The successful candidate will lead the development and the implementation of regulatory strategies for ... but are not limited to: - Serve as a Combination Product Regulatory Lead and provide leadership within Regulatory and cross-functional teams for assigned products… more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management, enterprise strategic planning, risk management, as well as strategic ... venture investments in healthcare as part of our Global Health Innovation fund. Together, we identify business critical opportunities, evaluate options, and ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …interactions with Japan and Europe as required.Responsibilities- Lead the Global Finance and Procurement Capability Building Program - Design a comprehensive ... training program for Global Functional Skills Finance, Procurement, and other functions of...within US Finance and Procurement teams, as well as Global GCPM teams, CFO Leadership team- Lead … more
- Eisai, Inc (Nutley, NJ)
- …& resource management.Demonstrated track record as Study Director (or equivalent role) with Global Clinical Lead or Clinical Program Director accountability. ... we want to hear from you. The Executive Director, Global Clinical Development resides within the Oncology at Eisai....within the Oncology at Eisai. This Executive Director will lead franchise programs , and will be the… more
- Eisai, Inc (Nutley, NJ)
- …timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and committees. Qualifications ... guidance, and management of GRS teams responsible for large, late stage development program or for multiple early stage development programs . Using a hands… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the development of document and record management principles for Global GxP activitiesResponsibilitiesTraining Function Team Lead development of strategies ... development of role based curriculum approach and resources for training administration. Lead establishment and enhancement of common Global infrastructure for… more
- Formation Bio (New York, NY)
- …clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a ... of biologics manufacturing processes, formulation development, analytical methods, and global regulatory requirements. Proven ability to lead cross-functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cost savings, and deliver measurable value through sourcing excellence.Key Responsibilities Lead and support implementation of a Global Sourcing organization ... and as part of a cross-functional team.Excellent communication skills with global suppliers regarding materials and external sourcing programs .Comfortable in… 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 ... study sites on the Dose Preparation Instructions. Seek input from other global functions as needed; proactively identify and resolve any technical, communication,… more
- Eisai, Inc (Nutley, NJ)
- …operations staff while strategically planning and managing multiple clinical development programs across different phases.The VP of Global Clinical Operations ... is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects… more
