- Daiichi Sankyo, Inc. (Bernards, NJ)
- … cleaning needs for DS Programs / Studies.- Serve as the subject matter expert for Study Data Managers during the planning/start-up, conduct and close-out of ... areas centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end delivery of External data… more
- Merck & Co. (Rahway, NJ)
- …sites and global GMP SMEs.-Job Function:serve as a subject matter expert for good manufacturing practices (GMP) for drug products, active pharmaceutical ... and devicessupport remediation activities and pre-approval inspection readiness activitiesprovide expert guidance and assistance to our company's manufacturing sites… more
- Aequor (San Diego, CA)
- Expert Engineer - Automation/OT Hybrid San Diego site Pay range: - based on experience and qualificationsJob Description Summary: Provide technical support for ... in networking Analytical and Process Equipment for Gene Therapy Operations Data management: o Software / data integration o Data migration / archiving o… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based ... in Raritan, NJ. Role OverviewWe are actively seeking a proficient Master Data Governance Sr. Specialist with a specific focus on Materials orchestration throughout… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …end-user experience.Responsibilities- HR Systems ManagementAct as the principal functional expert and advisor for implementation and ongoing management and ... all system requirements for associated module(s).Serve as the Subject Matter Expert (SME) for respective modules to fully demonstrate knowledge and understanding… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …make a difference? The Position The Medical Director serves as the subject matter expert for our products and related data within a Therapeutic Area ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... head of Patient Safety will act as the safety expert to establish and maintain processes, procedures and controls...to technical complaint handling at NNI and NNCI Risk-Based Data Insights: Responsible for the creation of KPIs for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Sr. Specialist will also be responsible for researching and analyzing data relevant to EEO investigations, executing trend analysis, developing work products and ... Compliance, business leaders and employees. The Sr. Specialist leverages subject matter expert understanding of the application of EEO and affirmative action laws,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …metSubject matter expert (SME) in 2 or more focus areasSupports Data Monitoring Committees (DMCs) and due diligence activities for assigned product(s), as ... materials, in support of the PSL. Independently evaluates safety data of any source to identify potential safety signals...ensure timelines and business objectives are met. Subject matter expert (SME) in 2 or more focus areas. May… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... with us? The Position The purpose of the (Customer Data Platform) CDP Program Team Lead is to ensure...Serve as an NNI interface with vendors who provide expert staff, managing contracting and budgeting. Partner closely to… more
- Eisai, Inc (Nutley, NJ)
- …organizational, and commercial requirements.Define and execute IT compliance processes ( data privacy, GxP, JSOX).Manage Enterprise IT risks, dependencies, mitigation ... and regional teams on information security and protection, as well as data privacy initiatives.This role involves substantial global management across Tokyo, US,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... internal stakeholders through the integration of primary market research and secondary data analytics. Incumbent must have the knowledge and technical skills to do… more
- Merck & Co. (Rahway, NJ)
- …closely with DevOps teams on Infrastructure as Code, Automation, and Orchestration. Provide expert knowledge of cloud and data security architecture and consult ... Define strategy, governance, and drive best practices for protecting company data . Be responsible for evaluating new solutions and developing the supporting… more
- Merck & Co. (Rahway, NJ)
- …development, generation of experimental designs, execution experimental plans and data analysis to impact pipeline development and set strategic directionMentors ... lead the development of novel drug delivery technologiesIs a recognized subject matter expert in at least one area of drug delivery and/or drug product manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for the ... Review Boards (IRBs), and other site personnel as neededStudy-specific subject matter expert (SME) for internal audit or Health Authority (HA) questions related to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable for the ... and other site personnel as needed- Study-specific subject matter expert (ME) for internal audit or Health Authority (HA)...(MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing eligibility and medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the ... Review Boards (IRBs), and other site personnel as neededStudy-specific subject matter expert (ME) for internal audit or Health Authority (HA) questions related to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... Affairs and other NNI skill areas. External relationships include expert advisory board members, investigators, regulators, academic and pharma associations… more
- Merck & Co. (Rahway, NJ)
- …of trials, clinical trial design and Go/No Go decisionsServe as a subject matter expert and foster collaboration within QP2 and across functions to plan and execute ... of expertiseExcellent communication Skills including ability to effectively present complex data , development plans and strategies to various audiences in both… more
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