- 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
- 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
- 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
- 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)
- …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
- 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. (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
- 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. (Durham, NC)
- …make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant ... connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.Our Manufacturing Site in Durham,… 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
- 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
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... matter expertise, a strong understanding of drug commercialization and the regulatory landscape.In this role, the successful candidate will be responsible toLead,… more
- Aequor (Thousand Oaks, CA)
- …as the primary liaison representing the country and region with Manufacturing, Quality , Regulatory Affairs, Corporate & Local Planning, and Product Delivery ... environment), especially PowerPoint, Excel and Word Knowledge of analyses and reporting techniques Strong interpersonal skills Experience with data visualization… 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
- 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 ... on track and align on major milestones and business reporting requirements. The role has a team of Launch...role will drive alignment of commercial readiness activities with regulatory , medical, supply, market access and sales Implement Launch… 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
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program ... SOPs, and close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations… 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
