- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation, ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (eg, ... an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as...device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsible for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems. Lead the development of the global Data Integrity strategy and ... quality and integrity initiatives.Develop and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as… more
- Genmab (NJ)
- …driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, ... inspection readiness, and regulatory compliance.Act as a Data Standards or Clinical Systems Lead as...as a Data Standards or Clinical Systems Lead as needed. Regulatory and Submission SupportContribute to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. ... advanced knowledge of medical terminology capture and reporting of safety data , pharmacovigilance, industry best practices, and relevant regulatory requirements.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacovigilance, handling and processing of raw data and external data , CDASH/SDTM, industry best practices, and relevant regulatory requirements is ... ensure compliance with the programming standards and practices, SOPs, external/internal data standards, Good Clinical Practices (GCPs), applicable regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global data management strategy across regions and across studies/programs. Lead DM resource model internalization for both strategy and implementation in terms ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory complianceEnsures that Data Management Plans are consistent and… more
- Genmab (NJ)
- …Then we would love to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by the Head of Strategic Feasibility. ... Advances this effort through the coordination and development of data -driven early indication and program assessments, study-level feasibility assessments, robust… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …legal regulatory or compliance experience is required Technology and data analytics experience in a pharmaceutical or medical device compliance function is ... the Ethics & Compliance (E&C) Monitoring & Auditing function, prioritizing data analytics, trends, and insights in alignment with evolving government expectations,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the Novo Nordisk US Operations (USO) AI Center of Excellence. The individual will lead and manage a team of data scientists, including AI/ML experts and ... evolve the Data Science team to meet internal and market needs. Lead a high-performing, collaborative team environment.Core member of the AI Center of Excellence,… more
