- BeOne Medicines (Emeryville, CA)
- **General Description** **:** The Manager , Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible ... regulatory commitments, and regulatory data in BRIM, the Manager , Regulatory Compliance Programs ensures these activities are performed in a… 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
- International (Lisle, IL)
- …the front-line representative for International supporting compliance related issues. The Regulatory Compliance Manager supports a variety of reporting ... of customers worldwide. We're looking for a talented, experienced, and passionate Regulatory Compliance Engineer to join our team and help us take our company… 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...responsible for managing projects, processes, or programs with own manager oversight Full knowledge of FDA and Health Canada… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …major programs or initiatives, and may function in a project leadership role Regulatory Compliance : Ensures compliance with all Federal regulations, ... 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
- Aequor (San Diego, CA)
- …procedures.Evaluate and maintain quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements ... infrastructure qualification documentation and protocols, in accordance with global regulatory guidelines.Provide input into developing scope, actions, and timelines… 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)
- …coordinate and deliver comprehensive training programs that support clinical excellence, regulatory compliance , and medical affairs expertise across our global ... Conduct regular reviews of training programs to ensure relevance, accuracy, and regulatory compliance Implement quality improvement initiatives based on feedback… more
- ValSource, Inc. (Rahway, NJ)
- …Verifications and system walkdowns to confirm systems meet design and client specifications. Regulatory Compliance : Ensure compliance with all relevant ... locations, overseeing on-site validation and equipment qualification activities, and ensuring compliance with FDA, GMP, and other regulatory requirements.… 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
- 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
- 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)
- 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)
- …Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... operational/executional arms within the business.- - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of… 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 ... budgets and forecasts.Experience leading cross-functional teamsExperience supporting audits or regulatory inspections.Experience with Veeva QualityDocs /QMS and understanding of… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and ... audits, remediations implemented and CAPAs pending.Support Risk Mitigation programs to ensure compliance to regulatory guidelinesEnsure up to date audit CAPA… 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 ... validated systems through participating in release management, change control, periodic reviews, and audit trail reviews.What You'll Do: Responsibilities (Essential Role Responsibilities): Responsibilities will include, but not necessarily limited to the… 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
- 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
