- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety/Quality/Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous ... living. Are you ready to make a difference? The Position The Patient Safety, Compliance & GxP Operational Excellence Lead is responsible for driving efficiency,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and track training completion rates to ensure compliance with safety and regulatory requirements Lead the development and delivery of training on case ... based on feedback, compliance audits, and evolving regulatory standards Key Area #2 Lead the...also offers time off pursuant to its sick time policy , flex-able vacation policy , and parental leave… more
- Formation Bio (New York, NY)
- …pertaining to developing and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life ... and guidance, interprets and notifies appropriate personnel and works with regulatory policy /intel. Makes recommendations for regulatory department… more
- Novo Nordisk Inc. (WA)
- …health outcomes. Are you ready to realize your potential? The Position The Team Lead , State Government Affairs oversees the State Lobbyist team, in all aspects of ... an Administration, including communicating, advocating, and executing Novo Nordisk's policy positions. Proactively collaborates with internal partners on all aspects… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development and implementation of Inflation Reduction Act ("IRA") processes and compliance activities for the Medicare Drug Negotiation Program. Ensures accurate and ... of Maximum Fair Price ("MFP") effectuation requirements consistent with regulatory requirements, NNI policies and procedures and Sarbanes-Oxley regulations.… more
- Genmab (NJ)
- …and adherence to corporate complianceCurrent working knowledge of US-specific legal, regulatory , and compliance regulations and guidelines relevant to industry ... a Director, HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an exciting, passionate,...work with integrity-we do the right thingOversee direct report compliance with the Genmab Code of Conduct, guidelines and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the...ensuring high quality and complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations in accordance with… 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 ... in the development, communication, and implementation of nursing and organizational policy and procedure. Participates on intra and interdepartmental committees and… more
- Eisai, Inc (Nutley, NJ)
- …of commercial call logs and HCP payment records Serve as the operational lead for Eisai US's Compliance Monitoring Program, managing internal resources and ... including vendor selection and onboarding Present updates to senior leadership on compliance trends, regulatory changes, and program enhancements C ontribute to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have a strong background in documentation management, process oversight, and regulatory compliance within the pharmaceutical or biotechnology industry. ... Programs, and other CMR Functional areas. This job will lead a team of Patient Safety training and vendor...years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotechnology… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Implement Medical Review Prospective ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Director is responsible for mentoring coaching and meeting the compliance requirements for the Medical Review Team. Relationship Reports… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Monitor internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...relationships within Intake and Triage, Medical Review, Submissions and Compliance , Global Safety, and centralized teams (eg, Training and… more
- Merck & Co. (Rahway, NJ)
- …Expert (SME) - Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead .-- The responsibility of this position is across ... standards established in 9CFR and enforced by USDA-APHIS-CVB Inspection and Compliance (IC), and Policy , Licensing and Evaluation (PEL).Develop and maintain… 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
- 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...for process improvements; make improvement recommendations to management and lead implementation of solutions May collaborate with Global Safety… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline ... the primary toxicology subject matter expert for interactions with regulatory agencies (FDA, EMA, etc.); support or lead...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of pricing implications and downstream impact of the evolving public policy , government, regulatory landscape and other relevant trends Identifies ... of pricing implications and downstream impact of the evolving public policy , government, regulatory landscape and other relevant trends Continuously… more
- Novo Nordisk Inc. (Boulder, CO)
- …of technical teams required Experience working to standards required for regulatory compliance of Aseptic Processing facilities required Understanding of ... perform formulation studies in a laboratory setting as needed. This position will lead a team of Drug Product Managers and manage their own projects. Relationships… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include delivering high-performing teams across designated therapeutic areas that lead to best-in-class field teams and defining capabilities and frameworks ... for patient support field teams. This role will oversee program operations, compliance , vendor contracts and relationship management. AD will drive collaboration and… more
