- Daiichi Sankyo, Inc. (Bernards, 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
- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support… more
- Merck & Co. (Rahway, NJ)
- …ISS clinical trials (300+). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites across more ... than 60+countries, all in accordance with US and WW regulations, company policies and Standard operating procedures. - - This individual will be responsible for managing external vendor(s)/partner(s) who provide resources and services that are critical to the… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may… more
- 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
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …the organization to drive and align the development and maintenance of global labeling (eg CCDS, regional product labels, and patient labeling ) for assigned ... compounds. Makes recommendations and provides labeling advice and feedback for labeling content, processes, and timelines to ensure compliance with labeling … more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The AD, Regulatory Affairs Product Labeling Content: Leads and manages the coordination of activities of labeling matters for assigned products ... and providing substantial functional support for discussions, drafting/revising product labeling (US Prescribing Information) and compiling supportive documentation in… more
- J&J Family of Companies (Raritan, NJ)
- …role and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA. The Associate Director , Global Labeling Product Leader is a leading expert individual ... accounting for new and changing government regulations. The Senior Manager, Global Labeling Product Leader will be responsible for the following: + Lead the… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …reviews, revises, and approves content and context required of promotional labeling materials for prescription drug and medical device products. Must be ... reviews, revises, and approves content and context required of promotional labeling materials for prescription drug and medical device products. Must be… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... key regulatory milestone, and activities for agency filing + Coordinate with the Labeling Lead for the development/maintenance of product labels + Ensure labeling… more
