- Eclaro (South Plainfield, NJ)
- …client in Piscataway, NJ. ECLARO's client is a leading consumer products company with a global presence. If you're up to the challenge, then take a chance at this ... for relevant commodities in accordance with client policies. Follow the Global Procurement governance in all projects, CRMC (Contract Risk Management Committee)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate in global ... assigned to alliance assets for operational matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory ... Lead actively engages with leadership across the Global Regulatory Affairs and Clinical Safety organization...that they own. Lead large-scale change initiatives across Global Regulatory Affairs and Clinical Safety and… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the ... 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)
- …communications for the company's worldwide manufacturing organization, which spans a global network of sites for pharmaceuticals, vaccines, biologics and animal ... stakeholder engagement communications activities in close partnership with teams across the Global Communications function. This role is based in Rahway, NJ. Scope… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle ... & Respiratory Therapeutic Area (CV&R). The incumbent will be expected to lead multiple programs including those new to the organization therefore requiring someone… 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 & ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key Ofunctions. Lead the Device… 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 ... research areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible… 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/or analytical development activities and oncology project development.Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA ... 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)
- …Experience (UDX) strategies. In this position, the Non-Regulated Implementation Services Lead will collaborate closely with cross-functional Global DX teams, ... 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
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible ... Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report...programs, target product profile, and competitive labeling precedent.Act as Global Labeling Lead , supporting development, approval and… 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 ... functions of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. Develop a strong, positive strategic business partnership with various business… 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 Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… more
- Merck & Co. (Rahway, NJ)
- …Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, has primary responsibility ... to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications...field of m elanoma . The Executive Director, PDT Lead will manage the entire cycle of clinical development,… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global Clinical Drug ... planning of operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply team. The individual will have the ability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global ... leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
