- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data ... stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external ...to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process improvements. Collaborating with the Global QMS eCompliance team , the director oversees QA plans, promotes data governance, and engages stakeholders ... centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D... team . Lead an enterprise cross-functional QA team to deliver state-of-the-art data -driven solutions.Design a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery ... requires demonstrated line management experience and the ability to manage/ lead people and a variety of projects concurrently. Additionally,...in the Local Lab FAQ log for Local Lab team discussion topics, data trends, and escalations.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Review, Data Surveillance, targeted source document verification and targeted source data review. Lead the team to develop and implement metrics ... around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets...activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as the Point of Contact ... (PoC) for gathering country/region specific CDx RA requirements from local RA team members (eg from Japan, China, Australia, Canada, Korea etc.)For recruitment in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …designated programs.Ensure proactive representation of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality ... areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and ... on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject matter ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… 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 ... oversee a team of safety physicians and scientists across various regions,...event in relation to the drug. Ensure all relevant data and findings are incorporated into comprehensive safety reports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Merck & Co. (Rahway, NJ)
- …products, as well as combination product stewardship for inline products. The Executive Director will lead multiple functions in the department of approximately ... Job DescriptionThe Executive Director , Device Technical Operations is a pivotal leadership...and ways of working to guide them through transformation initiatives. Team Leadership and Development: Lead , mentor, and develop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …improved commercial manufacturing processes and outcomes.The Director will build and lead a high-performing small team of technical experts, fostering a ... Legend Biotech is seeking a Global Director of Platform Innovation as part of the...of Platform Innovation as part of the Technical Operations team based in Raritan, NJ. Role OverviewLegend Biotech is… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope ... / cluster representative for initiatives at all levels of the organization.Build and lead the team to effectively manage resources ensuring appropriately skilled… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for GDX global and regional projects requiring Validation services and Technical Lead assignments.ResponsibilitiesOversee and manage a team of Validation Leads ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Merck & Co. (Rahway, NJ)
- …the Associate Director of Launch Strategy and Operations, you will lead the enterprise preparation of multiple product launches in Immunology. You will ... Job DescriptionAssociate Director , Launch Strategy and OperationsLocation: North Wales (Upper...US (HH-US)Therapeutic Area: Immunology About Us: Join our dynamic team at the forefront of transforming the US market… more
- Merck & Co. (Rahway, NJ)
- …strive to understand our customers' needs and provide solutions to meet their needs.The Director , Global Market Access Oncology, lead the pipeline TROP 2 asset ... policies.The position will include, but is not limited to the following responsibilities: Lead the cross functional Global access, Team .Actively collaborate with… more
- Merck & Co. (Rahway, NJ)
- …As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our ... touch every aspect of our business processes, systems, and data .The Associate Director will collaborate and interact...listed above and be able to work in a team environment identifying gaps in the QMS documents.Working knowledge… more
- Merck & Co. (Rahway, NJ)
- …Team Management: Lead a high performing Pune GCPA Vaccines team , driving data -driven decision making and delivering actionable insights to support ... Job DescriptionDirector, Vaccines Global Commercial Pipeline Analytics, HHDDAOur Human Health Digital Data and Analytics (HHDDA) team is innovating how we… more
- Merck & Co. (Rahway, NJ)
- …metrics Recognize team achievements and promote a culture of appreciation Lead business improvement initiatives and leverage networks to drive change Enhance ... passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across...Innovation! If you're passionate about biologics and ready to lead a high-impact team , this is your… more
- Eisai, Inc (Nutley, NJ)
- …and programmers to ensure the quality of CRO deliverables and on QA of data outputs. 10%5. Functions as lead statistician in global registration trials and ... he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs… more
