- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Technical Data Reviewer reports to the Data Review Supervisor or quality management (ie, Manager or Director). The reviewer will ... Raw Material, Finished Drug Products, Stability and Microbiology testing. Data Review may include release, raw material,...Review may include release, raw material, and stability data and laboratory notebooks. Additionally, the reviewer … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …facilitation, and post-inspection-related activities under the supervision of the IMT Lead.Management Review : Collect the data and information needed to ensure ... standards for continuous improvement and operations excellence. This may include the review of business partner SOPs and participation in QA initiatives.Partner and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintain specifications as per CDISC SDTMIG. Perform SAS programming to provide complex data review listings and reports to support Data Management and ... and database structures.Develop reports & graphs in Spotfire for easier data review and visualization. This includes developing programs for patient profiles on… more
- Merck & Co. (Rahway, NJ)
- …reference and nomenclature data into a centralized databasePerforming data integrity review activities, including proofreadingDeveloping rules to ensure ... Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small molecules… more
- Genmab (NJ)
- …and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities and ... and authentic is essential to fulfilling our purpose.The Role:An Associate Director, Data Management is operationally responsible for the oversight of Clinical … 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 ... a difference? The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is responsible for supporting planning and… 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), ... and maintenance of animal facilities. This position is responsible for providing data , documentation, and other information as needed for annual reports to Federal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... group and across the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to achieve high quality and… more
- Insmed Incorporated (San Diego, CA)
- …report development, and database lock processesParticipate in activities related to data review , database lock, medical monitoring, and query resolutionWork ... through final reporting of results Provide scientific input and review of clinical study data , support in...scientific input and review of clinical study data , support in assessing medical monitoring reports, study integrity/conduct,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable ... Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/… more
- Genmab (NJ)
- …reports, as applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification plans Perform UAT ... needed Collaboration with Genmab Global Drug Safety:Participate in definition, review , and approval of data packages for Data Monitoring Committees Review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and maintenance of the CCDS, US and EU labeling, and manages the review of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with ... group and across the cross-functional and cross- regional representatives on the labeling review teams as well as with business partners to achieve high quality and… more
- Aequor (Salt Lake City, UT)
- …must be deferred to more senior QA personnel. Responsible for labeling issuance, review and/or returns; document processing including data entry, data ... issues on the manufacturing/packaging floor and during batch record documentation/ review . 6. Investigations and Recommendations: Participate in investigations and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical terminology concepts and industry standards and technical skills in coding data received from CROs and vendors. This position requires solid verbal/written ... working knowledge of medical terminology capture and reporting of safety data , pharmacovigilance, industry best practices, and relevant regulatory requirements. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Merck & Co. (Lower Gwynedd, PA)
- …develop and implement automation workflows and tools to increase the efficiency of processes, data review , and data visualization in support of our Vaccines ... updated or new LIMS systems, and develop visualization tools for the review of experimental data and for IT tools used to track material through automated… more
- Merck & Co. (North Wales, PA)
- …relationships with system and tool vendors and research new tools to enhance data capabilities. (10%) Impact: Under the supervision of their manager, the Sr. GTOS ... have strong analytical skills and be able to synthesize data and differing points of view to navigate to...with support from GO TA lead, at cross functional review meetings such as LDRC/EDRC TA DRC, FORce, Operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study/CRO plans across the portfolio.Ensure study-specific monitoring plans meet the above standards. Review quality oversight plans that CRO CRAs have in place to ... plan for on-site and remote site visits (expectations of staff contact, ISF review , IP review , SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit… more
- Genmab (Plainsboro, NJ)
- …and document reference architecture for various R&D systems and functions.Provide data architecture skills to support core solution architecting and integration of ... data sources, pipelines, and platforms, in collaboration with our Data & Analytics, and Data Science & AI colleagues.Collaborate with POD Managers, Product… more
- Insmed Incorporated (San Diego, CA)
- …and oversight of assigned clinical programs including monitoring of clinical studies, review & interpretation of clinical trial data , authoring clinical study ... and regulatory communications and documents, and monitoring of competitor activities and data . This individual will play a crucial role in formulating the company's… more
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