- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting , and publication.Specifically, the Senior Director ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (Rahway, NJ)
- …human health.This position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Insmed Incorporated (NJ)
- …to help us expand what's possible for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs, Tactical Implementation, you'll ... the future of science, we're in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs team… more
- Merck & Co. (Rahway, NJ)
- …:This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and ... function areas. Primary Activities :Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
- Insmed Incorporated (NJ)
- …Safety to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, DSPV, you'll be the medical expert for assigned ... completed on time and in accordance with all relevant company and regulatory policies and procedures. In addition, the Senior Director will be responsible,… more
- Merck & Co. (South San Francisco, CA)
- …project teams, working closely with biomarker scientists, clinical and medical leads, regulatory affairs, clinical operations, and CMC teams. Reporting & ... implementation of novel PET tracers in oncology studies, guide regulatory submissions, and act as the PET imaging expert...ensuring robust study design and high-quality PET data collection. Regulatory support : Familiarity with regulatory and… more
- Insmed Incorporated (NJ)
- …to help us expand what's possible for patients with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, ... a strategic leader, ensuring that development programs meet scientific, quality, regulatory , and commercial standards, while ensuring execution across internal teams… 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. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings,… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... health.This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics. The… more
- Insmed Incorporated (NJ)
- …for creating and implementing programs that ensure workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key duties ... This position will also work with staff to provide in-depth regulatory expertise, robust interpretation, clear guidance and employee education regarding a… more
- Merck & Co. (Rahway, NJ)
- …(canine, feline), equine, and livestock (beef, dairy, swine, poultry, aquaculture). Reporting to the Executive Director, Channel Operations & Engagement, you will ... marketing teams within the organization along with sales, product development, regulatory affairs, customer service, and other cross-functional teams to ensure an… more
- Insmed Incorporated (NJ)
- …Neurology to help us expand what's possible for patients with serious diseases. Reporting to the VP, Clinical Development - Gene Therapy, the Executive Director will ... & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data.… more
- Genmab (NJ)
- …standards and other industry standards that supports the exchange of data, reporting , and analysis. Ensures alignment of SDTM standards with data collection ... study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality… more
- Cipla (Fall River, MA)
- …maintenance of the QMS in line with GMP (Good Manufacturing Practice) and regulatory requirements (eg, FDA, ). Maintain and ensure the proper documentation of all ... up to date and correctly implemented. Assist in the collection, analysis, and reporting of quality data (eg, quality metrics, CAPA (Corrective and Preventive Action)… more
- Insmed Incorporated (NJ)
- …requests Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, ... Collaborates with cross-functional team members within Biometrics, Clinical Operations, Regulatory , and Clinical Development, as well as with external vendors.… more
- Merck & Co. (Rahway, NJ)
- …cell-line platforms. This role will be a member of the Process Automation team, reporting to the Process Automation leader. In this role, this individual will be ... systems.Lead integration of control systems with MES, Quality, and Batch Reporting applications.Understand and adhere to CFR, GMP, and data integrity regulations… more
- Insmed Incorporated (NJ)
- …team to help us expand what's possible for patients with serious diseases. Reporting to the Director, Clinical Systems & Business Intelligence, you'll be responsible ... FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and other applicable regulatory guidelines.What You'll Do: In this role, you'll have the opportunity to work… more
- Insmed Incorporated (NJ)
- …to help us expand what's possible for patients with serious diseases. Reporting to the Compliance Manager, Analytical Services, you'll be essential to maintaining ... using the Veeva Quality Management System to ensure alignment with regulatory and internal quality standards.Work closely with Quality Assurance, Regulatory… more
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