- Aequor (Devers, TX)
- …accordance with our client's policies, standards, procedures, and Global cGMP. Functional responsibilities include:Ensuring manufacturing compliance with applicable ... with clarity and accuracy.Able to effectively multi-task.Knowledge of US and global cGMP requirements.Must have strong authorship and ability to critically review… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and MDR and relevant vendors. Internal stakeholders: Global Safety, QPPV office, Global Development , Product Supply , Regulatory Affairs (NNI/NNCI) ... education and collecting data to support efficacy and new product development , CMR is involved. The one...cross-functional teams or committees and external environments at a global and regional level as required Timely completion of… more
- Eisai, Inc (Raleigh, NC)
- …other local and global functions, providing support to ensure ongoing uninterrupted supply , should any product supply for forecasting issues arise. ... from you.The Sr. Supply Planner will monitor supply chain activities for a global Brand....on delays to production and delivery plans.Supports any new product launches, technical transfers.Assists in cross-functional and global… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an effective manufacturing and supply organization, supporting teams for the commercial supply of a CAR-T product in the US market.Provide both technical and ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...Biotech is seeking a Vice President US Manufacturing and Supply , Cell Therapy Facility GM as part of the… more
- Merck & Co. (Rahway, NJ)
- …analysis in response to evolving global demand dynamics.Engage in resolution of global product supply disruptions where long-term strategic supply ... organization for our company's Manufacturing Division product supply chain strategy in alignment with Global ...the Product Development Team (PDT), Development and Commercialization Team (DCT), and Global … more
- Merck & Co. (North Wales, PA)
- …of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, ... product in-license/due diligence review, product divestment and product withdrawal.Support new technology development .Demonstrate an understanding of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Project Team (GPT) for these plans, ensuring appropriateness throughout the product 's lifecycle and across different indications. Represent Global Regulatory ... articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). ... global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...launched brands. The role will be responsible for the development and maintenance of Short to Long Term Forecasts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... 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)
- …scientist with an outstanding scientific track-record and passion for pharmaceutical product development . -This individual will use innovative approaches to ... early and late stage development candidates including screening, design, and development of formulations defined by robust drug product compositions and… more
- Aequor (Thousand Oaks, CA)
- …Job Responsibilities Advancing Operations strategy for optimization of the commercial product supply network (across drug-substance, drug- product , finished ... partners with the FDP manufacturing network, quality, engineering, external supply and global logistics in developing the...o Supporting product commercialization decisions that define product supply chain strategy and launch readiness… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides ... strategic and operational leadership on new product labeling in collaboration with the Global ...Daiichi Sankyo, and where applicable, partner companies for the development and approval of US, EU and global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV ... Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides ... strategic and operational leadership on new product labeling in collaboration with the Global ...Daiichi Sankyo, and where applicable, partner companies for the development and approval of US, EU and global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also require participation in supervising, training and developing entry-level business development professionals within the Global BD function (eg ... Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to meet smooth transition with other sub projects with respect to supply , product quality and stakeholder satisfactions. Responsible to communicate and ... 4 or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documentation for budget approvals. The Lead will also manage vendor relationships, Product Vendors and licenses, oversee global project budgets, and ensure ... development , implementation, and integration (API based) of non-regulated global corporate systems, including regional/ global websites, portals, and process… more
