- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …outsourced or contracted activities utilizing both performance and quality measurements.The Associate Director , SCBM Financial Reporting & Strategy position ... management and liaises with internal/external stakeholders on cross-functional initiatives.The Associate Director , SCBM Financial Reporting & Strategy's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The CRA Oversight Associate Director plays an integral role in the strategic development, ... and implement a monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures as outlined… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders. + Provides… more
- BeiGene (Hopewell, NJ)
- **_General Description:_** The Associate Director Site Technical Services is responsible for the day-to-day activities of the Validation team, Metrology, CMMS ... technical services functions. Supports site objectives, whilst adhering to regulatory compliance and achieving commercial success. Reviews, authors and works with… more
- Sanofi Group (Bridgewater, NJ)
- ** Associate Director , Omnichannel Strategy, US Vaccines** To enable Sanofi's Play to Win ambition, and to compete and win in an ever-changing and increasingly ... competitive healthcare environment, we have created the Marketing Operations and Execution Team, of which the Omnichannel Engagement Strategy Team for US Vaccines… more
- Sanofi Group (Bridgewater, NJ)
- …gastrointestinal diseases. **Main Responsibilities:** The Global Medical Immunology Pipeline Associate Director , Gastroenterology, reports to the Global Medical ... needs. + Work effectively within the established corporate and industry compliance guidelines + Support advisory boards, outreach meetings at key institutions,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... optimizations on relevant topics. **Responsibilities** - Supports CMC regulatory compliance activities for portfolio biologics to meet US, International Conference… more
- Sanofi Group (Bridgewater, NJ)
- …respiratory, and gastrointestinal diseases. **Main responsibilities:** The Global Medical Director of the Dermatology, reports to the Global Medical Head ... plans. + Work effectively within the established corporate and industry compliance guidelines. + Represent medical teams at advisory boards, outreach meetings… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …record keeping and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling ... approval for either the US or EU. + Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to...for the review of country labeling deviations. + Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs, ... systems and architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business leadership in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. **Responsibilities** + Study ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. Responsibilities + Study ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… more
