- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Senior Director Commercial Innovation drives commercial innovation with a specific focus on the obesity ... mitigate risks before scaling initiatives. Relationships Reports to the Executive Director of Strategic Operations. This position interacts with senior leadership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director in assuring Novo Nordisk compliance with internal SOPs and Federal ... to regulatory agencies. Supervise designated personnel. Relationships Report to the Director Regulatory Affairs. Develop and maintain positive rapport and working… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …think creatively to solve Outstanding team- and client-facing communication skills Project management skills Quantitative analysis skills Statistical programming ... us? The Position The Senior Manager - Market Access Insights works with the Director - Market Access Insights to explore key market access topics of interest and… 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 ... optimized manner Develops and presents compelling plans and recommendations for management endorsement Function as subject matter expert on digital patient access… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiatives for the Global Finance and Procurement organization and oversee project management for Finance, driving coordination, communication, and change ... various initiatives. Through a passion for capability building and strong project management skills, this role will engage with diverse stakeholders across… more
- Formation Bio (New York, NY)
- …reduce timelines, and support decision-making in biologics development and manufacturing. Project Management Own CMC timelines, budgets, and resources across ... faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …decision-making skills. Skilled at conflict resolution / negotiation.Strong project management skillsConsiderable organization awareness (eg, interrelationship ... other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position requires skills in working in a fast-paced environment, continuous improvement, project management , change management , and risk management . ... and builds and maintains positive relationships with internal/external stakeholders/vendors/partners. Project Management : - Accountable for completion of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …priorities.Will be expected to serve as the lead with the vendor & project management requirements for initiative completion.Will partner with the Director ... centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is...to serve as the lead with the vendor & project management requirements for initiative completion. Will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred Experience Qualifications 7 or More Years of related experience, including Project Management , Clinical Supply Management , and/or Pharmaceutical ... The qualified candidate will provide knowledge-based coordination, authoring, and management of Dose Preparation Instructions in support of clinical studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …policies, regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, ... research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspections. Finally, this position has advanced skills in continuous improvement, project management , change management , and risk ... disorders. Job Summary: Position sets the vision, direction, and strategy for Data Management globally and ensures execution of the data management strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates ... the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to create and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization ... to MA activities for internal QA team (global/ local), but also to:Global Project TeamsGOMA and Specialty MA Management teamsData Management / Biostats… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and procedures.Conduct other projects as assigned within, or by, Global Project Management & Leadership group.Qualifications: Successful candidates will be ... GDP training, GPM&L Project Review Meeting, GPM&L Staff Meeting, GPM&L Records Management Training, etc. Prepare agenda and assist in management of monthly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other departments to ... as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and security, supported by regular audits, data maintenance and continuous improvement processes. Project Management : Effective management of timelines and ... the relevant HRIS Module(s) including technical process and annual cycle management , documentation, testing, training and support materials for end-users, handling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people ... start-up, conduct, reporting, and close out) including timeline, quality, and budget management . Drives and leads the successful execution of all operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to ... Biostatistics Data Management & Data Ops for EDC, edit checks, data...for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance for… more
