- Novo Nordisk Inc. (Plainsboro, NJ)
- …multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve as a member ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also interacts with other therapeutic area leaders and joint Alliance partners.Responsibilities: Lead a multidisciplinary Global Regulatory Team (GRT) ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Merck & Co. (Rahway, NJ)
- …Description of Position- This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). ... Switzerland, Canada, Japan, Australia and BrazilStay abreast of evolving global regulatory landscapes for medical device and...analysis of data for management review. Reports to - Director Regulatory Compliance, Device Quality and … more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you.The Director , Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the ... , IT Security, Compliance, & Architecture, s/he is the Global IT department's trusted leader and manager...regulatory change review and change management process.Team Leadership: Lead the global teams in the execution… more
- Merck & Co. (Rahway, NJ)
- …keeping up with the latest regulatory guidelines and trends.Collaborate with global regulatory teams to align strategies and ensure submission readiness in ... Job DescriptionThe Executive Director , Device Quality & Regulatory will...regulatory Chemistry, Manufacturing, and Controls (CMC) content for global submissions, ensuring adherence to international regulatory … more
- Merck & Co. (Rahway, NJ)
- …(GPO) is a team dedicated to addressing privacy and data protection on a global scale.-The Associate Director , Global Privacy Operations, Data Subject ... experience in operational excellence, process design, program management for a large global company.Demonstrated record and proven ability to lead complex,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... medicines to help people. 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)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the marketplace through a focus on DEI&B and highlights Novo Nordisk as a market leader in the DEI&B space. Relationships The Director , DEI&B reports to the VP, ... for remote/in office dedicated time. EST time-zone hours. The Position The Director , Diversity, Equity, Inclusion & Belonging (DEI&B) plays a pivotal role in… more
- Merck & Co. (Rahway, NJ)
- …Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us ... technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate...while developing and expanding your career.-- As GxP Strategic Lead , you will be part of a team that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders. Director , Diagnostic Sciences Global Companion Diagnostics Job Summary The ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...of Dx devices under design control process. They will lead identification and selection of Dx assays and partners… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA Training and Documentation management team. This position will take direction from global strategy and operational QA leader , however is also accountable to ... to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA… 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. (Bernards, NJ)
- …as the CMC working group leader of GPT. He/she will supervise the PJ Lead ADC/Bio#2 member and is the accountable for the ADC/Bio#2 and an integral member of the ... and/or analytical development activities and oncology project development.Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA… more
- Merck & Co. (Rahway, NJ)
- …with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support ... Job DescriptionJob Summary: -The Director of Device Technology Transfer is a key... global and site-specific projects, facilitate technology transfer, and drive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best practices.Ensure /support ... research relevant duties under the RDPV QA functionMust have proven ability to lead and influence others within a global /matrix environment in the pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare.Our company is seeking a highly motivated candidate for the position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop… 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 ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic… more
