- BeOne Medicines (Emeryville, CA)
- **General Description** **:** The Manager , Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is ... responsible for driving program -level compliance initiatives, monitoring regulatory operations, and ensuring...commitments, and regulatory data in BRIM, the Manager , Regulatory Compliance Programs… more
- CHRISTUS Health (San Antonio, TX)
- …adhere to the core values of the corporation. Directs patient care in compliance with regulatory standards such as Joint Commission and state licensure ... for assigned areas; at CHRISTUS St. Patrick Hospital. The nurse manager affects departmental outcomes through interpretation, implementation, and evaluation of… more
- LE Cox Medical Centers (Monett, MO)
- …relates to their job. Assists General Manager as needed to complete regulatory compliance surveys. ▪ Completes all of the departmental, hospital and system ... the Assistant General Manager in leading and managing the department or program , promoting the mission, goals, budget and performance standards for the area to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … programs or initiatives, and may function in a project leadership role Regulatory Compliance : Ensures compliance with all Federal regulations, guidance, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...tasks performed by suppliers and business partners to ensure compliance with SDEA requirements. Relationships This position reports to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory submission-related activities. Updates internal processes to ensure compliance with health requirements and expectations. Qualifications A Bachelor's ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one.... May be responsible for managing projects, processes, or programs with own manager oversight Full knowledge… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …As a member of the REMS Strategy and Operations department, the Senior Manager , REMS Data Programmer will provide support for FDA mandated Risk Evaluation and ... Mitigation Strategy (REMS) programs and other patient and product risk management initiatives. This role reports to the Associate Director, REMS Analytics and… more
- Merck & Co. (Rahway, NJ)
- …Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... clinical development teams and the operational/executional arms within the business.- - The Program Clinical Supplies Project Manager ( Program CSPM) serves… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and deliver comprehensive training programs that support clinical excellence, regulatory compliance , and medical affairs expertise across our global CMR ... regular reviews of training programs to ensure relevance, accuracy, and regulatory compliance Implement quality improvement initiatives based on feedback and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have a strong background in documentation management, process oversight, and regulatory compliance within the pharmaceutical or biotechnology industry. ... 7+ years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotechnology industry Strong… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience and ensure technical complaints are managed with internal timelines, compliance and regulatory requirements. Relationships Reports directly to Patient ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...you ready to make a difference? The Position The Manager - Technical Complaints Call Center Oversight is responsible… more
- Insmed Incorporated (NJ)
- …coordinates the management and execution of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.Detailed management and ... for the future of science, we're in. Are you?About the Role:The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US Operations (USO) post-marketed products. This role processes cases based on timelines, compliance and regulatory requirements. This roles also serves as the ... you ready to make a difference? The Position The Manager PS Case Management is responsible for the management...the hubs and vendors according to the Internal and regulatory timelines Perform daily compliance checks to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Vault Quality system. Supports development of comprehensive, relevant resources (eg training program , FAQs) to enable local compliance to Deviation process ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...requirements. Execute regular surveillance, follow-up, and reporting program to ensure local process compliance . Acts… more
- Insmed Incorporated (San Diego, CA)
- …lifecycle management and remain in a validated state per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of ... and resolution guidance. Train, coach, and mentor GxP system owners. Provide CSV program trainings, lunch and learns and guidance to new stakeholders as well as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives of more patients than ever before. The Position The Brand Manager , Hemoglobinopathies is responsible for marketing activities directed at customer channels to ... Commercial Head. Collaborates closely with cross-functional teams, including marketing, medical, regulatory and legal, and other relevant NNI departments to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, ... internal systems audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure… more
- International (Lisle, IL)
- …the front-line representative for International supporting compliance related issues. The Regulatory Compliance Manager supports a variety of reporting ... the needs of customers worldwide. We're looking for a talented, experienced, and passionate Regulatory Compliance Engineer to join our team and help us take our… more
- Insmed Incorporated (NJ)
- …in a validated state (eg SDLC, IT Change Control) per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of ... support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)Generous paid time off policies, fertility and family-forming benefits,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to maximize your potential with us? The Position The Regional Security Manager US Ops position has responsibility for the development, implementation and management ... perimeter defenses, supply chain security, general investigations, security related compliance issues, physical and logical access control and profile management… more
- Repligen (Waltham, MA)
- …and Documentation: Own updates to SOPs as necessary. Ensure asset-related activities meet regulatory and internal compliance (eg, FDA, GMP, ISO)Data Analysis and ... contribution drives progress. Join us!The Blue Mountain Reliability Asset Manager is responsible for the administration, implementation and continuous improvement… more
