- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune 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...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis position 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 Regulatory Leads (GRLs) and Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working...in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDLContributes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... to Health Authority)- Participant and voting member in the labeling development process in the Labeling Working...in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDL-… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization ... acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains product information and labeling … more
- AbbVie (Newark, NJ)
- …LinkedIn. Job Description *Position can sit remotely anywhere in the US The Director , Patient Centered Outcomes Research, is responsible for the design and execution ... functions (eg, Clinical Development & Operations, Regulatory, Commercial). The Director , Patient-Centered Outcomes Research, will support a therapeutic area and… more
- Organon & Co. (Jersey City, NJ)
- …of development through registration and mature products. The Executive Director could also support business development due diligence activities. ... such as press releases for accuracy and consistency of message. + Review labeling ; manage label negotiations with agencies worldwide as appropriate to obtain and… more
- Merck (Rahway, NJ)
- …portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The ... supply needs per protocol and providing the signal for sourcing, labeling , packaging, and distribution for development products and non-company marketed products.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory guidance to ... biologics/vaccines, and in the rare disease space. In this role, the Director defines and implements regulatory strategies; works with cross-functional project teams… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC, you will be responsible for providing operational ... to GMP regulations and guidelines in relation to manufacturing, packaging/ labeling /serialization and distribution of small molecule and combination drug device… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Pipeline Head for Neuroscience, Global Health Economics, Value, and Outcomes Date: Jun 20, 2024 Location: Parsippany, United States, New Jersey, ... observational and real world data studies, surveys, and economic models. The **Senior Director , Pipeline Head for Neuroscience** , will develop the TA strategies for… more
- Compass Group, North America (New York, NY)
- …Ambulatory EVS. Learn more at www.Crothall.com. Job Summary Working as an Assistant Director , you will be responsible for directing and leading all aspects of the ... the cleanliness of work areas + Supervises the requisitioning, sorting, labeling , and issuance of professional equipment + Coordinates sterilization, assembly, and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As a Director , Global Regulatory Affairs, Precision Medicine you will develop and execute ... INDs, CTAs, IDEs, SRDs, PMAs, device clinical performance study applications and labeling for drug and diagnostic products. + Manage internal and external… more
- Bristol Myers Squibb (Madison, NJ)
- …Align regulatory plans with commercial and development plans + Develop target labeling and co-lead the cross-functional labeling team. + Ensure consistent ... positions are presented in responses to global health authority (HA) queries. + Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. + In collaboration with the… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related ... RA Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and… more
- Bristol Myers Squibb (Madison, NJ)
- …or GRL as needed + Provide strategic direction (and content input) on US Labeling + Anticipate and interpret key trends and changes in the global/US regulatory ... environment and provide strategic guidance regarding development plans as a result. + Foster positive relationships with FDA. + Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion &… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …schedules and coordinates daily priorities for incoming raw materials and labeling components, in-process testing, finished product sampling, in-process labeling ... incoming raw material, in-process material, finished product and in-process packaging/ labeling operations sampling and inspection activities. + Trains, supervises… more
- Union County College (Cranford, NJ)
- …and esthetically pleasant, physical environment. Under the direction of the Associate Director of Maintenance and Facilities, the Custodial Site assists in the ... personnel. * Identifies staff opportunities and keeps the Associate Director informed. * Prepares requests for purchases of materials,...records of equipment and supplies to ensure compliance with labeling and the requirements of the Right to Know… more
- WellLife Network (Great Neck, NY)
- …and sanitation guidelines and regulations to ensure quality food service. + Wrapping, date- labeling , and storing food items. + Menu planning and food ordering; may ... and example. + Performs other related duties as assigned by Director /Supervisor. + Participate in regularly scheduled interdisciplinary team meetings, as needed.… more
- Robert Half Finance & Accounting (South Hackensack, NJ)
- …solution. Position Overview The Associate Project Manager reports to the Associate Director of Project Management. The Associate Project Manager supports the project ... of materials, making copies, delivering materials to a job site, shipping samples, labeling locations on site + Performs site surveys at project sites: taking… more
