- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... advise on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in defining and executing the … 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...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Policy activities focused on the USA, alongside coordinating the global team.Responsibilities Lead and manage a global regulatory intelligence and policy ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...of leading Regulatory Intelligence, this role will lead the development and implementation of a global… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- 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 ... into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...or More Years of proven experience in a regional regulatory lead role7 or More Years of… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development. ... product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Global Oncology Communications The role of Director , Global Communications, Oncology is a unique opportunity to join our Company, a ... for this role will work under the guidance of the Executive Director , Global Oncology Communications in a fast-paced and ever-changing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the generation, integration ... and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management responsibility… more
- Merck & Co. (Rahway, NJ)
- …review and final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and ... to Executive Director or Associate Vice President, Therapeutic Area Lead .Develops worldwide product regulatory strategy to optimize label and obtain… more
- Merck & Co. (Rahway, NJ)
- …, Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will lead overall strategy development for Women's ... commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling, launch readiness reviews, organized… more
- Merck & Co. (Rahway, NJ)
- …in 2023.We are seeking a leader to take the position of the Associate Director Global Marketing, who will be responsible for maximization of the late ... organization. This role provides a unique opportunity to serve as a GBL ( global brand lead ) and gain unique and valuable experience.Specific Responsibilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary The purpose of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry ... set the outsourcing strategy for the regulated bioanalytical sciences and will lead regulatory interactions related to bioanalysis and evaluates/sets the… 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 ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … education and process development projects, as required. May serve on or lead global initiatives (eg, process improvement, Protocol review, training, SOP ... Science function. This position may be at the executive director level or senior director level, depending...Project Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global… more
- Merck & Co. (Rahway, NJ)
- …drive revenue and productivity, thereby advancing our company's contribution to global medical innovation.Enterprise IT (EIT) is an essential component of the ... SAP Platform Team is responsible for our company's SAP Global Template asset, delivering enterprise-level capabilities through harmonized business...the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all… 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 ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...quality metrics and share with study team, Operations Program Lead , and Sr. Director for the compound,… 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
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... motivated and experienced individual to join our team as the Associate Director of Patient Marketing, focusing on email and performance marketing strategies. The… 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 ... disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is...key responsibilities are within and for GCO to: 1) Lead and implement the establishment and oversight of an… more
