- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... meetings globally. Responsible for representing GRA in the GPT ( Global Project Team) as well representing the...into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT… more
- Insmed Incorporated (Bridgewater, NJ)
- …and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy for Insmed marketed and to-be-marketed ... productsResponsibilitiesIn close collaboration with Regulatory project leads in the US, EU,...in the pharmaceutical industry, 7+ years of experience in global regulatory labeling Full understanding of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... medicines. You will lead a global regulatory team to...Denmark. Essential Functions Serve as a member of the Global Project Team (GPT) utilizing precedent and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... 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
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. JOB SUMMARYThe Director , Clinical Project Management will manage assigned project (s), including ... to effectively prioritize work and engage in creative problem solving to manage global projects. Pro-actively identify, analyze and resolve project issues to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, ... partner side) CDx RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents, breakthrough therapy designation requests, orphan drug applications.Participate in global project team meetings (development and/or marketed ... and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... who are likely to benefit from our therapeutics.ResponsibilitiesLeads CDx project teams for the diagnostic, in full alignment with... teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …early/late stage drug development experience ideally including time in role such as a Global Project Leader at Sr. Director level or equivalent preferred- ... research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has… more
- Merck & Co. (Durham, NC)
- … management experience Risk Management experience Experience supporting regulatory inspections- Change Execution Management / Strategy Realization Framework ... We work in the local plant connected to our global manufacturing network to ensure the highest quality of...substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for...or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and execution on local, regional, and national level with measurable outcomes required, global project success desired We commit to an inclusive recruitment ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... regulatory , and compliance standards. Collaborating with business and EIT...Privacy standards through continual risk and security assessment.Collaborates with global stakeholders from EIT and leaders across regions in… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 ... excellence in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex… more
- Merck & Co. (Millsboro, DE)
- …11, Good Manufacturing Practices, Computer Systems Assurance, track and trace, and other global regulatory requirements that impact IT and OT systems in ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site...The Site Digital Technology Lead is the representative for Global Animal Health Manufacturing IT (GAHM IT) on the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … project activities Understands high level import/export requirements for global distribution of clinical ancillary materials and ensures the appropriate ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Merck & Co. (Rahway, NJ)
- …endpoints including proportional hazards models.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics ... Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global...in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs),… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and maintaining awareness of best practices for reproducible data science, global regulatory requirements, internal guidelines and Standard Operating Procedures ... 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. (Basking Ridge, 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...position may serve as an ad hoc member of Global Project Team (GPT) to address labeling… more
