- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Director , Consumer Marketing, will be a pivotal driver in shaping an insights-driven consumer ... Proven knowledge of the pharmaceutical industry, including medical, regulatory, clinical processes and market dynamics, especially within identified therapy area… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory), Finance, and Novo Nordisk global colleagues, to deliver ... with strategic alignment.Effective in fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams through… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Director , Market Intelligence and Portfolio Insights will leverage Competitive Intelligence methodologies ... to provide key insights into the biopharmaceutical landscape across clinical , commercial, and enterprise domains. This role involves applying data interpretation and… 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 ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for efficiencies across the Novo Nordisk portfolio. Relationships Reports to the Director , NovoCare Platform and Services. Key internal relationships include IT, all ... optimizations across both live and self-service support Maintain robust compliance, quality and privacy standards in handling customer information and programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... determining audit targets for GxP systems.ResponsibilitiesLeadership and Strategic DirectionThe Sr. Director , Data Quality and Integrity is essential in… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical ... CDP planning and individual protocols to facilitate successful implementation of programs. Clinical Operations:Ensure high quality delivery of all studies for… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to optimize laboratory data processes, technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical ... This position develops and proposes strategies for laboratory data ensuring all clinical trials meets quality requirements and best practices. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision ... within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of group members. This position also monitors trends in functional performance via quality , time, and cost indicators, and develops plans and leads the execution for ... and cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced… 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 with the Global Oncology Medical Affairs (GOMA), Oncology Business… more
- Formation Bio (New York, NY)
- …guidelines. Potentially supervises and manages external contracted medical writers to ensure quality and meeting of timelines for all clinical development and ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... the individual to bring the latest knowledge in these fields, ensuring high quality and efficiency. This role will be responsible for recruiting and developing the… 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
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs...the PositionAs Formation Bio's dedicated IP Counsel at the Director level, you will own the IP function for… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… 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
- Evolent (Trenton, NJ)
- …Join Evolent for the mission. Stay for the culture. **What You'll Be Doing:** The Director , Clinical Quality is a pivotal role, spearheading continuous ... to enhance clinical outcomes and operational efficiency. Additionally, the Director , Clinical Quality will support a portfolio of performance initiatives… more
