- Merck & Co. (Rahway, NJ)
- …objectives. Within the EIT SAP Platform Team, the EIT SAP Integrated Delivery & Design Authority Lead will assume the crucial role of leading the SAP Design ... end-to-end business processes. They will provide strategic direction, manage the Design Authority team, and ensure the efficient and effective operation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the processes associated with Blinded Independent Central Review (BICR) vendors.Responsibilities:Protocol Development: Ensure appropriate imaging strategy ... analysis) applied to study; author imaging sections of protocol; conduct periodic review of standardized protocol language to ensure alignment with current practices… more
- Merck & Co. (Millsboro, DE)
- …training and oversight of the animal care staff, serving as a designated reviewer and voting member of the Institutional Animal Care and Use Committee (IACUC), ... renovation or construction of facilities in which animals are housed, including design and maintenance of animal facilities. This position is responsible for… more
- Merck & Co. (North Wales, PA)
- …to the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and ... as the liaison and manages correspondence with FDA's promotional review divisions Office of Promotion and Advertising Review...and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the… more
- Merck & Co. (North Wales, PA)
- …tools for the production of Study Data Tabulation Model (SDTM) datasets. Design and develop complex programming algorithms and user interfaces.Supporting project ... aCRF; knowledge of Analysis Dataset Model (ADaM) and Analysis Data Reviewer 's Guide (ADRG) considered a plus.Excellent communication and interpersonal skills and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and reviews IME grant proposals, represents Medical Affairs in Promotional Review Board (PRB) activities including reviewing medical and scientific content of ... Serve as NNI Medical Affairs representative on Medical & Science Team Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical… more
- Merck & Co. (Rahway, NJ)
- …and external to GDMS as well as our company when needed.Responsible to design , create, validate, review , approve and maintain data management tool ... tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in… more
- Merck & Co. (Rahway, NJ)
- …and antibody-drug-conjugates. The qualified candidate would have expertise in design , development, optimization and transfer of robust label-free affinity and ... in the group to establish these types of assays, to write and review technical reports, and to participate in cross-functional teams.The candidate would have good… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Architect is responsible for leading triaging, root cause analysis, solution design and implementation until problems are resolved. Relationships Reports to the ... Serve as a subject matter expert and lead architecture design of websites and web applications Conduct necessary data...test scenarios to build an effective and efficient solution Review all SDLC documents associated with new functionality and… more
- Merck & Co. (North Wales, PA)
- …those needs.Transform and manage Oncology and Non-Oncology Promotional Content Review Operations, including:Oversee Associate Directors and support them in ... implementing opportunities to improve the review process for both oncology and non-oncology brand teams.Directly drive the transition from dedicated promotion … more
- Catalent (Philadelphia, PA)
- …that they conform to requirements of cGMP and Clinical Trial Protocol.Includes review of material status, protocol conformance, clinical design layout, ensuring ... Quality Assurance Document Control individual is responsible in preparing customer files, review and approve batch records, and release batch records and finished… more
- Merck & Co. (North Wales, PA)
- …plans and determines appropriate statistical methodology for data analysis.Participates in database design meetings to ensure that the data evaluated are in high ... agencies, or individual investigators.Provides responses to queries relating to study design , analysis, and interpretation posed by the clinical monitors, regulatory… more
- Merck & Co. (Durham, NC)
- …and our Company's Quality Management System.Supporting areas such as Design , Commissioning, Qualification and Compliance covering Manufacturing Equipment (isolator, ... formulation vessel, lyophilizers, etc.).Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents… more
- Tris Pharma (Monmouth Junction, NJ)
- …analysis plans and data displays; provides input to Case Report Form (CRF) design and data management processes; Performs periodic review of clinical ... Clinical Leaders and other scientific colleagues, the incumbent contributes to the design , data collection and reporting of clinical studies in a manner consistent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …well as external suppliers and partners. Essential Functions Lead evaluation, design , and analysis of enterprise-wide solutions Translate business and technical ... in the development and/or maintenance of technical documents. Reconciles solution design with business requirements. Designs application prototypes when necessary … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design . In addition, he/she will develop a QSP strategy to ... feasibility, efficiency and validity of new modelsConduct extensive literature review to identify suitable mechanistic elements, interactions, rate constants and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(CSR): Leads statistical activities for medium complexity studies including study design , protocol development, CRF review , SAP development, analysis files ... for medium complexity studies including contributing to development of optimal study design , independently develop and execute statistical analysis plan and helps in… more
- Merck & Co. (Rahway, NJ)
- …the Specialist level will serve as a team member of the MACS Center Basis of Design Phase and will go on to support new and/or existing facilities across the Small ... the selected candidate will contribute to automation equipment and software design , system commissioning/qualification, as well as other automation areas critical… more
- Eisai, Inc (Exton, PA)
- …early to late stage manufacturing programs.This position will be responsible for the review and interpretation of analytical testing data as well as protocols and ... company's discretion. Essential Functions Managing external testing lab collaborations 15% Review and interpretation of analytical data 20%Troubleshooting of analytical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study report (CSR): Leads statistical activities for complex studies including study design , protocol development, CRF review , SAP development, analysis files ... supports early phase oncology development and leads complex studies in study design , statistical analysis and interpretation of results with some supervision. This… more
