- Aequor (New York, NY)
- …as an occupational nursing professional Minimum experience of 1-3 years in case management, utilization review and/or quality assurance Experience in episodic ... services to employees within regulated scope of practice and disability case management. Experience/Education: MS/NP in nursing degree and current NP license… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other functions) to implement clinical development plan: study ideation, protocol development, review case report from creation, study initiation, study conduct ... allocation, budget allocation, and assessment of needs including training, data review tools, etc.Standing PRG reviewer for mid-to-late-stage asset protocolsCore… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …medical support. Support MLs with ISS development, such as providing independent reviewer support when needed Analysis and translation of insights and Competitive ... exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications Doctorate degree in...The Company may however extend this time-period, in which case the posting will remain available on our careers… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date ... of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …teams.Develop, implement and maintain SAS programming standards and performs quality checks. Review annotated case report forms and database structures.Develop ... per CDISC SDTMIG.Perform SAS programming to provide complex data review listings and reports to support Data Management and...reports & graphs in Spotfire for easier data review and visualization. This includes developing programs for patient… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …assessment from a physician's perspective- May provide clinical input into the eCRF ( Case Report Form) design, participate in the UAT (User Acceptance Testing) and ... CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review Plan- Accountable for the assessment of protocol deviations-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of regulatory submissions. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation and SDTM dataset, ... guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis...identify data inconsistencies and support data review , review analysis dataset specifications and ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …under some supervision to solve complex study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners ... forums, workshops and training on new guidances, regulations to enterpriseSharing case studies with enterprise Qualifications: Successful candidates will be able to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and managing a learning program from content to delivery. ** Prior to applying, review the Education & Qualification section - Be sure you possess the Minimum years ... project kick-off decks, project status updates, executive summaries and case studies, and document client meetings. Qualifications: Successful candidates will… more
- Insmed Incorporated (Bridgewater, NJ)
- …from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.Production of ... eg MACE, Potential events related to metabolite, Liver enzymes. Review of mortality cases, evaluation of CIOMS, production of...with PIs in each reported SUSAR to understand the case assessment. Production of initial narrative to understand each… more
- Tris Pharma (Monmouth Junction, NJ)
- …of safety vendors Oversees adverse events handling, including individual case reviews, assessment of expectedness and relatedness; Collaborates closely with ... Drug Safety activities including, but not limited to: safety data review , signal detection, risk communication including safety information updates, potential risks… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Development of People Ensure that reporting personnel ... 15, 2024. The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk-us/careers.com… more
- Merck & Co. (Rahway, NJ)
- …then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please ... Management, Stakeholder Relationship ManagementPreferred Skills:Business Analysis, Business Analysis, Business Case Analyses, Business Case Development, Business Data… more
- Merck & Co. (Rahway, NJ)
- …supplier relationships such as: Vendor selection, contract negotiation & review , supplier risk assessments, savings calculations, financial controls, budgeting, ... cost savings and assessing other terms and conditionsProvide business case support for supply decisions based on cost optimizationPrepare,...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …is: Accountable for HHDDA Taxonomy, Demand Management Tool & Project Approval & Review (PAR): Acting on behalf of Human Health Operating Committee (HHOC) and HHDDA ... and synthesize inputs.Maintain a taxonomy playbook complete with structured business review templates to facilitate tradeoffs / reprioritization discussions with BU… more
- Merck & Co. (Rahway, NJ)
- …and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and associated ... coordinates cross-functional regulatory support for development programs and marketed products. Review and provide final approval of local registration study… more
- Merck & Co. (Rahway, NJ)
- …and/or support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard ... on best practices. Author lessons learnt through after action review summaries or other reports to capture knowledge gained....pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (Rahway, NJ)
- …AH enterprise application architecture.Design and chair the Animal Health Architecture Review Board (AH-ARB) to facilitate the governance process for architecture ... managing architecture governance processes, such as leading an Architecture Review Board (ARB).Experience integrating legacy systems with modern technologies to… more
- Merck & Co. (Rahway, NJ)
- …guidance and work with stakeholders to prepare such guidance for review /approval.Identify and promote best practices. Adhere to SOPs, ethics and departmental ... then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please… more
