- Merck & Co. (Rahway, NJ)
- …, Mentoring Staff, People Management, Pharmaceutical Management, Professional Networking, Regulatory Communications, Regulatory Compliance Audits, ... & Controls ( CMC) , Pre-approval Pharm will bring scientific and regulatory expertise, innovative approaches, and strong industry and FDA connections to our… more
- Lundbeck (North Hyde, SD)
- …for imported goods. Analyse scientific content of registration packages to ensure regulatory compliance . Liaise with government departments and consultants to ... activities across our product portfolio. This role is critical in ensuring compliance with local regulatory requirements for Lundbeck's products, overseeing … more
- Eisai, Inc (Nutley, NJ)
- …accredited law school or CPA preferred Minimum 7 years of experience in healthcare compliance within the pharmaceutical or biotech industry Experience in ... including vendor selection and onboarding Present updates to senior leadership on compliance trends, regulatory changes, and program enhancements C ontribute to… more
- Merck & Co. (North Wales, PA)
- …Process Improvement Projects, Project Management, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory ... initiatives. This role is responsible for ensuring data integrity, accessibility, and compliance with regulatory standards, while also enabling business users to… more
- Merck & Co. (Rahway, NJ)
- …to manufacturing, ensuring robust introduction, qualification, and performance monitoring. Regulatory Compliance :Collaborate closely with R&D and Manufacturing ... systems, including knowledge of damage mechanisms, common defects, and performance testing. Regulatory Compliance :Strong knowledge of relevant regulatory … more
- Merck & Co. (Philadelphia, PA)
- …Process, Manufacturing Quality Control, Organizational Performance Management, Quality Management, Regulatory Affairs Compliance , Regulatory Change ... Job DescriptionDescription The Associate Specialist of Regulatory Planning & Publishing works closely with various stakeholders of regulatory and safety… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …center intake, Technical Complaints handling, customer care and Triage to ensure regulatory compliance Lead efforts to optimize call center workflows, implement ... internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including… more
- BioAgilytix (Durham, NC)
- …and rule-based checks to identify data discrepancies in real-time, enhancing regulatory compliance and minimizing errors.Independently design and configure basic ... that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data… more
- Merck & Co. (North Wales, PA)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... industry experience, at least 6 of those in a regulatory and/or compliance area and experience with...package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family),… more
- Merck & Co. (Rahway, NJ)
- …Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance , Regulatory Requirements, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- CoxHealth (Lake Spring, MO)
- …future issues. The specialist serves as a liaison between patients, families, healthcare providers, and regulatory agencies to uphold patient rights, improve ... patient satisfaction, and maintain compliance with regulatory standards. This role involves...advocacy * Skills ◦ Advanced knowledge of patient rights, regulatory requirements, and healthcare ethics. ◦ Strong… more
- Merck & Co. (Durham, NC)
- …Project Management Tools, Project Planning, Project Portfolio Management (PPM), Regulatory Compliance , Risk Management, Risk Management and Mitigation ... materials or managing a portfolio of complex process changes with regulatory impact Responsibilities Business Case Development Understanding the requirements of a… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Quality Control, Manufacturing Scale-Up, Manufacturing Systems, Regulatory Compliance , Results-Oriented, Technology TransferPreferred Skills: ... enhance data monitoring capabilities, and drive excellence in safety, compliance , supply, and productivity.Global Impact:Collaborate with colleagues across the US… more
- Merck & Co. (Upper Gwynedd, PA)
- …Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5 more}-Preferred Skills:Job Posting ... integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare . Our Company is on a quest for cures and is committed to being… more
- Merck & Co. (Rahway, NJ)
- …Numerical Analysis, Pharmaceutical Development, Pharmaceutical Research, R&D Strategy, Regulatory Compliance , Scientific Modeling, Statistics, Veterinary ... Job DescriptionOur company is a global healthcare leader with a diversified portfolio of prescription...scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and… more
- Merck & Co. (Rahway, NJ)
- …Clinical Practice (GCP), Nursing, Patient Education, Quality Management, Quality Standards, Regulatory Compliance , Regulatory Requirements, Regulatory ... area-specific modules, monitoring processes, and systems. Maintain training materials in compliance with applicable SOPs, policies, and regulatory requirements.… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing, Process Improvements, Product Formulation, Quality Management Systems (QMS), Regulatory Compliance , Regulatory Requirements, Safety Standards, ... from the Operations Director.Works within budgetary/financial objectives set by Director- Compliance - Responsible for creating and sustaining a culture that… more
- BioAgilytix (Durham, NC)
- …to industry frameworks (NIST CSF, ISO 27001).Oversee governance, risk, and compliance activities, including policy development, regulatory alignment (GxP/CLIA, ... and operational technology security (eg, segmentation, firewalls, secure remote access). Compliance frameworks and regulatory requirements (eg, ISO 27001,… more
- Merck & Co. (Rahway, NJ)
- …platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and ... management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... shooting and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external… more
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