- Genmab (NJ)
- …a fit? Then we would love to have you join us!The RoleThe Senior Manager , Clinical Programming is responsible for the establishment, governance, and integrity of ... Tabulation Model (SDTM) standards that support the scientific need of a study/ program while ensuring quality, consistency and compliance to CDISC standards and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders to execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance ... around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP...have proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical … more
- Insmed Incorporated (NJ)
- …and teamsProven ability to work within a multi-functional team (legal, regulatory , clinical /medical, quality, research, etc.)Able to multi-task and prioritize ... future of science, we're in. Are you?About the Role:The Senior Manager , Global Medical Information will be primarily responsible for creating/updating/reviewing… more
- Insmed Incorporated (NJ)
- …Role:Reporting to the Sr Director, Quality Assurance - Pharmacovigilance, the Manager of Pharmacovigilance Quality Assurance serves as a strategic partner managing ... quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and...Drug Safety & Pharmacovigilance (DSPV), Medical Information (MI), and Clinical Departments. The incumbent will provide support and promote… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Manager , Programming will provide statistical programming and analytic support clinical ... studies. As a team member of the Programming function, the Manager , Programming will be working interactively with functional colleagues from Biostatistics, … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a Strategic Initiatives & Capacity Expansion Project Manager as part of the Technical Operations team based in Raritan, NJ. ... for strategic initiatives and capacity expansion activities at the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effective project management in cross-functional drug development teams or clinical , regulatory , pharmaceutical sciences/technical operations in the ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , Site PMO as part of the Technical Operations team based in… more
- Insmed Incorporated (NJ)
- …with project goals including Manufacturing, Analytical Development, Quality Assurance, and Regulatory , with input from Commercial, Research, and Clinical .Prepare ... throughout all stages of product development, including Research, Preclinical, Clinical , Regulatory , Operations, Quality Assurance.Innovative thinking and an… more
- Insmed Incorporated (NJ)
- …abilities within the team. In addition, this individual may also take on a leading program manager role for major programs. As a leader, the Executive Director ... and lead activities associated with moving Insmed's late-stage pipeline through clinical development, regulatory submissions and commercial launch. This position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
