- Xcelerate Solutions (Frederick, MD)
- Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking a Senior program analyst who will support Joint Program Executive ... Office for CBRN Defense (JPEO-CBRND) Medical Regulatory and Acquisition Strategy (MRAS) team. In...ensure compliance with regulation + Monitor EVMSs appropriate for pharmaceutical development and within the constraints of the FDA… more
- Guidehouse (Philadelphia, PA)
- …Market Access team focuses on value, access, pricing and commercialization strategy projects for pharmaceutical , biotechnology, medical device, and diagnostics ... experience, with demonstrated experience in value, access, pricing and commercialization strategy projects for pharmaceutical , biotechnology, medical device, and… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + 7-years CMC regulatory experience in the pharmaceutical industry with a history of… more
- Cardinal Health (Lincoln, NE)
- …who provide consulting services in a myriad of capacities, including: + Global Regulatory Strategy Development + Global Regulatory Affairs + Chemistry ... Standards + Drug, Biologic (IV, Injectable) and Medical Device Development + Regulatory Outsourcing + Pharmaceutical Compliance + Product Lifecycle Management +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (eg, technical regulatory strategy documents, storyboards, risk ... to drive organizational evolution. + Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support… more
- BGB Group (New York, NY)
- …marketing, helping them embrace the potential of these platforms while addressing regulatory challenges. From strategy development to execution, you will design ... regulatory concerns and build confidence in pharma social strategy execution. Community Management: Develop MLR-approved response matrices and provide oversight… more
- Otsuka America Pharmaceutical Inc. (Montgomery, AL)
- **Position Summary** Provides critical support in developing global regulatory strategy , planning and execution of global investigational and marketed ... **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy , planning and execution of global investigational and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary:** Responsibility for regulatory strategy to support the development of biomarkers, companion ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry experience and 4+ years direct or related CMC regulatory experience ... Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical… more
- J&J Family of Companies (Raritan, NJ)
- …are searching for the best talent for a** **Director, Global Commercial Strategy , Precision Medicine** **to be base in Raritan, NJ.** **Purpose:** The Director, ... Global Commercial Strategy , Precision Medicine will have responsibility for supporting the...with key cross-functional stakeholders in the global and regional pharmaceutical organization. The successful candidate should have diagnostic commercial… more