- 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...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external consultants to align regulatory … more
- Merck & Co. (Rahway, NJ)
- …Senior / R5-equivalent - About the role We are hiring a Senior Product Manager to lead strategic development of our Integrated Printing and Plastic Manufacturing ... across both industrial software and automation/controls. You will set the product vision, align multi-year strategy with executive priorities, and partner closely… more
- Insmed Incorporated (NJ)
- …meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all ... device combination product development at various development stages and product lifecycle management.Stay current with regulatory guidelines and industry… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Maintain learning management systems and track training completion rates to ensure compliance with safety and regulatory requirements Lead the development and ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...Evaluate training curricula and make adjustments based on feedback, compliance audits, and evolving regulatory standards Key… more
- Merck & Co. (Rahway, NJ)
- …successfully execute, design verification strategies for assigned drug-device combination product program (s) for successful clinical introduction(s) and ... development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and… 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 ... all departments, such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory , Analytical Development, Materials Management, and… more
- Merck & Co. (Rahway, NJ)
- …executive level and build cross-functional partnerships.Solid understanding of security, compliance and regulatory requirements relevant to payments (PCI-DSS) ... end-to-end solutions for Manufacturing Finance processes (costing, production variance, product costing, inventory accounting, production planning integration, shop-floor interfacing),… 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...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Safety/Quality/Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Eisai, Inc (NJ)
- …and creating, developing, and administering in whole or in part, a training program which includes sales techniques and presentations, product and product ... & Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Product Training Skills,… more
- Merck & Co. (Rahway, NJ)
- …Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory ,...the timelines for bulk manufacturing-needs and release of drug product across assigned program (s). Works directly in… more
- Merck & Co. (Rahway, NJ)
- …launch in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities: Program Leadership and ... all activities are conducted with the highest regard for safety, quality, and regulatory compliance , aligning with the company's divisional and local site… 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
- 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...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …all aspects of training materials creation and documentation to ensure vendor compliance Program Compliance : Implements recommendations and implements ... team, Commercial Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality, Legal, Privacy and Finance. External… more
- Merck & Co. (Rahway, NJ)
- …stakeholders on GxP and regulatory trends as well as the auditing program 's ability to detect compliance to current and evolving expectations.-Ensure timely ... for a health authority (particularly USDA-APHIS-CVB-IC and/or -PEL) as an inspector, product reviewer, compliance officer, other GMP/ regulatory role or… more
- Cipla (Hauppauge, NY)
- …for printed packaging materials to ensure accuracy, compliance with regulatory requirements, and alignment with product specifications. This includes labels, ... proper storage, handling, and inventory of printed packaging materials to maintain product quality and compliance . Ensure proper storage, labeling, and inventory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …vendors according to the Internal and regulatory timelines Perform daily compliance checks to ensure adverse events, product quality complaints, and ... education and collecting data to support efficacy and new product development, CMR is involved. The one thing that...post-marketed products. This role processes cases based on timelines, compliance and regulatory requirements. This roles also… more
