- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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. **Summary** This 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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 Team (LWT), in collaboration with the CDL +… 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
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …possible. This job cannot be based in Basking Ridge, NJ._ The Senior Director , Global Marketing will be responsible for global strategic and tactical planning ... commercial meetings, pricing committee discussions, Joint Review Committee meetings and labeling working groups as needed. + Lead indication relevant strategy and… 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)
- …with HA deadlines. + Contribute in the developing of target labeling . **Degree / Experience Requirements** + Bachelor's degree required; advanced scientific ... degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ability to broadly represent the… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director of Comparator Strategy and Operations is responsible for managing clinical comparator & ancillary supply and sourcing strategies at the asset, ... and study levels for Regeneron clinical trials. The associate director will be part of a team that drive...Sourcing from low-cost markets + Pooled supplies + JIT labeling + On-demand procurement + Knowledge of regulatory guidelines… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …working within established timelines of investigational product manufacturing, labeling , release, distribution and return/destruction, and/or helping to establish ... of RFP, assumptions and SOW for CROs and IP services vendors ( labeling , packaging, distribution; IVRS/IWRS) + Provides input, reviews, and approves vendor study… 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
- The Estee Lauder Companies (New York, NY)
- …the day-to-day maintenance of new and existing development (reestablishment of standards, labeling submissions, etc.). + Collaborate with PD Director to evaluate ... OBJECTIVE: This Product Development Associate will work in tandem with the Director to help drive calendarized and non-calendarized initiatives for Skincare and… more