- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory ...within NAO Quality PV Oversight and NAO Quality Department as needed and assigned by ... the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory ...within NAO Quality PV Oversight and NAO Quality Department as needed and assigned by ... the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… 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. (Millsboro, DE)
- …an interdependent global manufacturing network that's committed to delivering a high quality , reliable supply to customers and patients on time, every time.Our ... departmentsReview and revise processes and procedures against corporate and regulatory policies.Review production records for completeness and compliance to… 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 ... language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of… more
- Genmab (NJ)
- …of high- quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help craft scientifically ... part of a dynamic, collaborative team that values innovation, quality , and scientific integrity? At Genmab, we are seeking...are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for...of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Imagine being a part of a team committed to helping people defeat diabetes and other serious chronic conditions. Here at Novo Nordisk, we seek ... related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our Marketing & Patient Solutions group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving the ... ready to experiment with us? The Position The Senior Manager , Patient Support Data Intelligence is responsible for process...assist with audits and inspections, both internal and by regulatory authorities Design, develop and manage tools which are… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Merck & Co. (North Wales, PA)
- …DescriptionIn Biostatistics and Research Decision Sciences (BARDS), a distinguished department within our renowned Research and Development division, quantitative ... 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)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific mentorship… more
- Merck & Co. (Rahway, NJ)
- …(e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with ... Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and integrity of trial conduct. Providing… more
- Merck & Co. (Durham, NC)
- …Durham sites.- This includes Energy Center, Vaccines Manufacturing and Bulk Facilities, Quality Labs, and Maintenance and Material Storage Facility (MMSF). At times, ... assisting with successful shutdown planning and implementation with associated department (s).- General Profile: Individual contributor role working with maintenance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of quality /performance and budget, resources and timelines across the department and ensures timely delivery of high- quality deliverables at reasonable ... Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the...of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires… more
- Novo Nordisk Inc. (Durham, NC)
- About the Department For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...the core processes to meet all customer, business & regulatory requirements through the following activities: People Focus, Process… more
- Capital One (Richmond, VA)
- Department Operations Manager - Regulatory Complaint Quality and Exec Close Loop (Hybrid) **Do these statements describe you? If so, please consider this ... getting to the root cause and driver of operational quality . You enjoy seeking and actioning stakeholder feedback. ....be regularly worked. McLean, VA: $126,700 - $144,600 for Department Operations Manager Richmond, VA: $115,200 -… more
- Tecomet (Woburn, MA)
- **TITLE** : Quality Assurance & Regulatory Affairs Manager ** Department :** Quality Assurance / Regulatory Affairs **Classification:** Exempt ... **Reports To:** Senior Director of Quality Assurance and Regulatory Affairs **Date:** XX Mar 2025 **JOB SUMMARY:** Provide overall company leadership and… more
- Cole-Parmer (Franklin, MA)
- Job Title: Sr. Manager , Quality and Regulatory Assurance Reports To: VP, Quality Position Location: Franklin, MA FLSA Status (Exempt/Non-Exempt): FLSA ... Status: Exempt Position Summary: The Senior Manager , Quality and Regulatory Assurance...all products or services + Maintain and communicate all quality data to department managers for problem… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …continued growth of Amneal and the department to reach company and department goals and maintain complaint with regulatory agency requirments. + Fosters and ... Description: The Manager , Field Alert & Recall Compliance is responsible...Field Alert & Recall Compliance is responsible for overseeing regulatory activities related to Field Alert Reports (FARs), product… more
