- Genmab (NJ)
- …and feel like a fit? Then we would love to have you join us!The RoleThe Associate Director , External Data Quality Management, is a strategic leadership role ... for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide… more
- Merck & Co. (Rahway, NJ)
- …key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing.... - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution. -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Eisai, Inc (Exton, PA)
- … Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end ... to optimize laboratory data processes, technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical… more
- Eisai, Inc (WA)
- …from you. The Data Operations Group at Eisai, Inc. is looking for Associate Director - Data Scientist/Programmer to create insightful AI powered instantaneous ... and non-technical audiences.Eisai Salary Transparency Language:The base salary range for the Associate Director , Data Scientist & Data Operations is from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to multiple aspects of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... accountable to drive the implementation of a quality strategy and quality plan closely aligned...RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring ... Program Quality strategy, model, and operations as a key member of Clinical Quality program leadership team. **What you bring to Takeda:** + BSc in a… more
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