- 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)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key...with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position Responsible for leading process, reporting and compliance related activities for US Talent Acquisition. Responsible for oversight of ... related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience working with drug-device ... Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management...Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summar y : The Manager , Data Management is accountable for end-to-end delivery of clinical data management ... collaborating with study teams, CROs, external vendors, and partners to ensure high quality deliverables are on time to support drug development processes and global… 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)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of… 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)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit ... provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... you ready to experiment with us? The Position The Manager of HCP Marketing will be a pivotal driver...access and public affairs (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …full alignment across internal and external stakeholders and partners Maintain robust compliance , quality and privacy standards in handling customer information ... Are you ready to experiment with us? The Position The Senior Manager , Patient Support Data Intelligence is responsible for process improvement, technology,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. ... and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees...of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Manager , Field Alert & Recall Compliance is responsible for overseeing regulatory activities related to Field Alert Reports (FARs), product ... staffing, and ensures timely follow-up, closure, and reporting. Additionally, the manager supports the development, revision, and maintenance of Global Quality… more
- Novo Nordisk (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
- Grifols Shared Services North America, Inc (Lehigh Valley, PA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more
- Sumitomo Pharma (Trenton, NJ)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Manager , Compliance , Training & Strategic Alliance (CTSA), PVRM** . The ... Associate Manager , Compliance , Training & Strategic Alliance (CTSA),...and maintenance of PV staff learning plans, assisting with compliance activities, quality monitoring, management of the… more
- Chemours (Trenton, NJ)
- …team! This position will report directly to the APM Product Stewardship & Regulatory Manager at our Wilmington, DE location or remote. **The responsibilities ... Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw material components and/or 5+… more
- Bausch Health (Bridgewater, NJ)
- …to Regulatory Authorities + Manage interactions with other BHC functions (eg, Quality , Compliance ) during Regulatory Authority inspections + Provide ... are in place and delivered to time cost and quality pre- and post-approval dossier management. Ensures that data...filing, approval, registration, market launch, maintenance of business and regulatory compliance . + Active member of product… more
- Highmark Health (Trenton, NJ)
- …the growing number of laws and regulations governing managed care organizations. The Manager , Medicaid Compliance & Operations acts as a trusted business ... to the risk assessment. + Oversee the development of Quality Action Plans and compliance work plans....for improvement. + Participate in operational meetings to provide compliance guidance and support. + ** Regulatory Monitoring… more
