- Merck & Co. (Upper Gwynedd, PA)
- …CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal Scientist in Pre-approval ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance with… 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
- Merck & Co. (Durham, NC)
- …in aseptic process simulations, including sampling, testing of simulation units, and reporting of data .Schedule daily testing of laboratory samples based on ... ingredient, finished product, and laboratory testing for the BCG vaccine.The Specialist, Quality Control participates in a team of analysts in the development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and continually improve data representation and delivery applications (including data quality ) in support of US Talent Acquisition Evaluates processes ... Are you ready? The Position Responsible for leading process, reporting and compliance related activities for US Talent Acquisition....for US Talent Acquisition. Responsible for oversight of master data and data integrity related to US… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting … 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting … 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting … 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
- Aequor (Thousand Oaks, CA)
- …smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance: Ensure all data management activities comply with ... and identify bottlenecks with new ways of working Implement best practices in data collection, cleaning, and reporting including knowledge of Pinnacle 21,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with and/or manage vendors and corporate partners related to Patient Support reporting , data and database management as appropriate Helps identify work-process ... assist with audits and inspections, both internal and by regulatory authorities Design, develop and manage tools which are...with a minimum of 8 years of experience in data management and reporting ; advanced degree preferred… more
- Merck & Co. (Rahway, NJ)
- …(SDS QM), provides oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug ... tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data... data standards plan, preparing questions for FDA e- data mailboxes (CBER/CDER), attendance at meetings with regulatory… more
- Merck & Co. (Rahway, NJ)
- …clinical development, including study design, initiation, execution,- monitoring, analysis, regulatory reporting , publication, and presentation at national and ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and… 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
- Twist BioScience (South San Francisco, CA)
- …solutions across our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams… more
- Merck & Co. (Rahway, NJ)
- …projects under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company ... in the cross-functional teams for the clinical trial planning, execution, and reporting .Develops individual protocols and data analysis plans and determines… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of ... responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting … 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. (Rahway, NJ)
- …collaborate effectively; andEffective knowledge and experience in developing analysis and reporting deliverables for research and development projects ( data , ... Job DescriptionResponsibilities:Provide high quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD Modeling… more
- Merck & Co. (Boston, MA)
- …to collaborate across departments to ensure awareness and access to high- quality information that drives scientific discovery and innovation.- The ideal candidate ... Familiarity with GenAI is a plus.-In addition, the candidate will leverage data to drive resource utilization and maintain up-to-date awareness of literature-related… more
