- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other initiatives. Proactively identifies and manages risks to data quality , data integrity, programming and reporting deliverables, and timelines. ... data protection, operational metrics, and clinical trial quality and risk management reporting requirements that...and processing of raw data and external data , CDASH/SDTM, industry best practices, and relevant regulatory… more
- Merck & Co. (North Wales, PA)
- …in the EMA region with responsibility of meeting the reporting deadlines and quality measures specified in local SOPs- - Data Centric Business System Owner ... and maintained . This role has broad accountabilities for the following: - Regulatory Data Management ( RDM) Strategy & Regulatory Data Standards… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, ... regulatory procedural documentation, in line with company-wide policy and relevant regulatory requirementsCoordinate with broader DS quality teams to support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This ... knowledge of medical terminology capture and reporting of safety data , pharmacovigilance, industry best practices, and relevant regulatory requirements. This… more
- BioAgilytix (Durham, NC)
- …to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA.Design data quality KPIs and implement initial quality checks independently, ... at diagnosing data challenges and designing innovative solutions to improve data quality , integration, and regulatory adherence.Capable of growing with… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... and trend evaluations, process characterization, new WCB qualification, and regulatory submission authoring, with a focus on standardization across programs.In… more
- Merck & Co. (North Wales, PA)
- …and presentation skills Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics, ... deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) US and/or worldwide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity- Oversee statistical ... monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality , proactively ensure the resolution of… more
- Merck & Co. (Lower Gwynedd, PA)
- … Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting , Regulatory Strategy ... may provide direct support to automation asset maintenance, system security, data management, obsolescence initiatives and all SDLC and Compliance needs.Job duties… more
- Merck & Co. (North Wales, PA)
- …presentation skillsBroad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- Job Description Primary Activities :Provide high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development ... skills; broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics,… more
- Genmab (NJ)
- …compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrityCreates quality ... to support the portfolio towards the ultimate objective of data quality and consistency across programs and...and other industry standards that supports the exchange of data , reporting , and analysisEnsures alignment of SDTM… more
- Eisai, Inc (Nutley, NJ)
- …training and oversight to employees and CROs on timeliness, completeness, and quality metrics.Manage the Safety Alert Reporting Departments, ensuring high- ... ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity.- Provide hands-on ... review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor,… more
- Insmed Incorporated (San Diego, CA)
- …scale-down models for biopharmaceutical processes, including interpretation of results and reporting that stands up to regulatory inspection.Demonstrated expert ... deliver under pressure and time constraints, while maintaining a high level of work quality .Ability to present scientific data and concepts to CMC team members… 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 ... affairs, market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs, and other relevant NNI departments to ensure alignment of… more
- Merck & Co. (North Wales, PA)
- …must also possess effective knowledge and experience in developing analysis and reporting deliverables for R&D projects ( data , analyses, tables, graphics, ... clinical development projects. Develop and execute statistical analysis and reporting deliverables (eg, safety and efficacy analysis datasets, tables, listings,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the individual to bring the latest knowledge in these fields, ensuring high quality and efficiency. This role will be responsible for recruiting and developing the ... operational execution and excellence by applying best practices in accordance with regulatory requirements and guidelines worldwide, and in alignment with the CSPV… more
- Merck & Co. (Durham, NC)
- …in order to resolve process/equipment issues, minimize downtime, and ensure product quality . - - This role will support manufacturing activities at the Durham ... Regularly help the team troubleshoot issues to minimize downtime and maintain product quality - Identify opportunities to improve the process ( eg cycle times, ease… more
