- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... Managers, Data Managers, Clinicians, vendors) to support the overall development strategyProficient in managing service agreements and vendor contracts.Where you… more
- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... Job Description Job Description: - The drug development Project Manager is part of Global Project...of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary Responsible for managing the design, development , optimization and administration of global HCM Platforms and processes. This ... as a liaison between the customer community and the software development team, documenting functional, system, and process requirements.Possess a blended… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …objective setting sessions, Mid-Year Assessments, Year-End Assessments. Leads an employee development planning with each direct report. Sustains the payroll staff by ... recruiting, selecting, orienting, and training employees. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and interpersonal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... under some supervision to solve complex study problems. Responsibilities Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The project teams will be defined based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on ... Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case...strategies and activities for early and late phase drug development candidates within the team to support overall CMC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Associate Director , Global Business Process Manager, Global DX is responsible ... transformation and automation across the organization. Responsibilities Process Design, Development , and Optimization:- Coordinate and lead the conception, design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... (CSR): Leads statistical activities for complex studies including study design, protocol development , CRF review, SAP development , analysis files development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must ... include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation ... requests, orphan drug applications.Participate in global product team meetings ( development and marketed products); provide regulatory support and guidance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Specialty Medicine Business Units and is responsible for executing business development opportunities across a range of categories designed to advance the ... require participation in supervising, training and developing entry-level business development professionals within the Global BD function (eg Fellow).Responsibilities-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& ManagementOversight of Data Request processing by Service ProvidersTraining and development of Service Provider resourcesFacilitates and participates in vendor and ... 8.0.x and 7.0.x Patches.Experience with SQL programming/querying, custom report design/ development from Argus Safety backend database.Strong knowledge of Oracle… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate ... growing portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … development . Are you ready to maximize your potential with us? The Position The Associate Director will be the lead who is responsible for ensuring that all ... Reports to the Sr. Director , Patient Support Solution Quality/Safety Associate Director . Interacts with colleagues within Patient Support Programs, Patient… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... trials. The ideal candidate will be responsible for overseeing the development and maintenance of clinical databases and ensuring the integrity, consistency,… more
