- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... policies, regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical,… 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)
- …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)
- …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 ... as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team...and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV ... and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient...Required Skills10 or more years of professional experience at senior management level leading quality organization and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful ... components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …risk management , and/or translational researchMust have excellent communication, project management , writing and analytic skillsMust be organizational leader ... CSPV HR-related matters, including performance reviews and departmental talent development.Line management and senior leadership accountabilities in CoELead a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of ... to ensure compliance, contract fulfillment, and service excellence.Oversee global project budgets to ensure cost-effective solutions that meet compliance and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Senior Director Commercial Innovation drives commercial innovation with a specific focus on ... prioritization, and budgeting Proven ability to work with and influence senior management Ability to synthesize complex information into user-friendly,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or internal project manager as a dotted line. Essential Functions Program/ Project Management : Oversee program/ project management for launches ... milestones, and measurement to drive successful execution. Drive stakeholders for effective project management and realization of objectives in timely manner… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …years of experience, including demonstrated history in business excellence, launch excellence, project management , project launch, or related roles ... with US operations within life sciences preferred Excellent communication and stakeholder management skills, with the ability to influence senior leaders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …incorporate brand positioning into payer value propositions. Relationships Reports to Senior Director , Value Communication and Contracting Strategy. Interacts ... private & public channels Have strong interpersonal; communication; analytical and project management skills Ability to translate strategies into measurable… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Managed Markets, Legal, Compliance, and Finance. The position has high exposure to senior management and requires a highly motivated individual who is able ... Develops accurate short- and long-term plans, forecasting, and business analysis Project Management and Quantitative analysis skills Intermediate proficiency in… more
- Merck & Co. (Rahway, NJ)
- …of clinical pharmacology components of regulatory filings. Preferred Skills and Experience: -Solid project management skills and the ability to partner with ... Analysis, Data Management , Data Science, Drug Development, Numerical Analysis, Project Management , Project Support, Regulatory Submissions, SAS Language,… more
- Merck & Co. (Rahway, NJ)
- …related discipline required , MS/MBA preferred . - At least 8 years of experience in project management . - - At least 5 years of experience in planning, ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong… more
- Merck & Co. (Rahway, NJ)
- …and negotiate with key c ross functional Leaders is critical. Th e Senior Director should have strong managerial experience, a high-level strategic understanding ... regulatory, clinical & pharmacovigilance processes- Demonstrated ability to collaborate with senior management and information workers on the importance and… more
- Merck & Co. (Rahway, NJ)
- …least three (3) years in direct management of shop floor production activities. Project Management - Proficient with Project Management and Virtual ... and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also… more
- Merck & Co. (Rahway, NJ)
- …DescriptionThe greatest inventions would not be brought to market without the right project management and administrative support. Woven into every part of the ... education or certifications such as (eg Certified Administrative Professional, Project Management Professional Certification, Professional in Human Resources… more
