- Daiichi Sankyo, Inc. (Bernards, NJ)
- …By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure ... compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model… more
- Eisai, Inc (Nutley, NJ)
- …and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes but is not limited to: Program design ... areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of Clinical...Assoc. Director of Clinical Programming will oversee the Data Review programming and JReview within IODS. Reporting to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planned, communicated and that audit targets for MA audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within ... to stakeholders via the QMS framework (ie, Quality Management Review , Quality Review Board) across the global medical affairs organization (Oncology and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …decision. By guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data ... submissions. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation and SDTM dataset, identify… more
- Aequor (Thousand Oaks, CA)
- …sampling for Biotech/pharma Proficiency in SAP and MES for batch record review and sampling documentation Strong attention to detail and excellent communication ... drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Oversight of annual reports Participate in project team meetings as assigned Review data from contributing departments (including NNAS) and provide comments to ... assure accurate and complete documents for inclusion in these applications Review of regulatory strategy documents; eg, provides supervisor with input on regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes globally. This role will be responsible for coordinating the authoring, review and approval of new or updated procedural documentation. In addition, this ... completing requests/initiatives from the GSOP Committee)Proactively manage required periodic review for controlled proceduresEnsure global and cross-functional consistency of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as needed.ResponsibilitiesContract Coordination: Collate exhibits to create contract draft, review contract documents for completeness and accuracy; ensure compliant ... and update CLM system/trackers throughout the process.Conduct Simple Negotiations: Review contractual amendment details against original contract. Ensure internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complex study problems.Responsibilities:Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as lead planner for all logistics related to execution of quarterly Business Review (BRM). Meetings are scheduled from HQ and include participation from the highest ... Develops ET meeting and offsite calendar, schedules Vision meetings, annual ET budget review meetings, NNCI BRM meetings, product working group meetings and other ad… more
- Merck & Co. (North Wales, PA)
- …/ training content development, business operations, system operations, and/or pipeline review .Under the broad guidance of the Executive Director, Head of our ... limited to:Conducting stakeholder interviews and focus groupsProcess mapping, process review , improvement identification, process redesignProcess improvement ideation, pro/con … more
- Repligen (Waltham, MA)
- …have thorough understanding of Good Documentation Practices (GDP), identification and review and approval of deviation investigations and Out of Specifications (OOS) ... metrics for daily tier meetings, Operations meetings and annual management review meetings. Review and approval of validation plans/reports, deviations, root… more
- Aequor (Aliquippa, PA)
- …staff and partner groups Perform receipt, storage, and distribution documentation review to ensure alignment with procedures, current Good Manufacturing Practices ... and other applicable regulations Perform cGMP process, procedure, document and record review , and approval, including but not limited to deviations, CAPAs, change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface with ... and build appropriate mitigations. Drive interface with Integrated Data Review , Data Surveillance, targeted source document verification and targeted source… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product safety team in critical areas such as individual case medical review , risk management, aggregate safety reports, and translational medical safety. This role ... May directly manage complex safety issues related to individual case review , risk management, translational medical safety, and aggregate safety reports, including:… more
- Merck & Co. (Durham, NC)
- …policies and procedures.-Responsible for ensuring required safety guidelines are followed.- Review and approval of electronic batch records and associated ... Quality management.Train employees on new or revised processes or procedures. Review and approve automation interventions.Actively participates in project suite… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operations. This role includes overseeing the marketing materials planning and review process, management of internal agency's operations, and facilitation of POA ... to measure the success and impact of the in-house agency as well as PRB review and approval Support and foster marketing efforts for all POA and regional meetings… more
- Merck & Co. (Rahway, NJ)
- …requests from the business and procurement.Typical Activities : Contract review /negotiations; PO issue resolution; creation of new vendors; supplier issue ... meetings with business partners and suppliers in connection with Target; review , analysis and negotiation of contracts pursuant to Target; data gathering/analysis… more
- Novo Nordisk Inc. (San Francisco, CA)
- …sites; ensuring effective coordination and facilitation of studies to ensure timely review , initiation, and completion, as well as publication of study results. ... standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications Doctoral degree required At least two… more
- Merck & Co. (Durham, NC)
- …Global Vaccine Technology (GVTE), Automation, and Quality approvers.-Perform a thorough review of design & engineering records and related Good Manufacturing ... in a timely manner, and implementing corrective actions to improve the execution/ review process for equipment.Develop training material. Working as a subject matter… more
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