- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key...with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality ,… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position Responsible for leading process, reporting and compliance related activities for US Talent Acquisition. Responsible for oversight of ... related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions… more
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience working with drug-device ... Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management...Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, … more
- Genmab (NJ)
- …and protocol deviations and is a key driver for inspection readiness, regulatory compliance , and successful data submissions.The Associate Director will lead ... or contribute to initiatives that improve operational efficiency, inspection readiness, and regulatory compliance .Act as a Data Standards or Clinical Systems… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for Legend Biotech.Lead and direct qualification activities to meet company goals, quality , and regulatory objectives. Qualification team will consist of ... managing external resources and some internal resources.Ensure safety, quality , and compliance is the main goal for all new and existing qualification… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summar y : The Manager , Data Management is accountable for end-to-end delivery of clinical data management ... collaborating with study teams, CROs, external vendors, and partners to ensure high quality deliverables are on time to support drug development processes and global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP/Document Audits supports end-to-end audit ... provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with ... you ready to experiment with us? The Position The Manager of HCP Marketing will be a pivotal driver...access and public affairs (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to the development of tools/techniques to enhance the project management processes Ensure compliance with the Quality Management System when repair, re-design or ... strategy development for risks to schedule, scope, resources, budget and quality . In coordination with project champion, conducts start-up meeting with project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …full alignment across internal and external stakeholders and partners Maintain robust compliance , quality and privacy standards in handling customer information ... Are you ready to experiment with us? The Position The Senior Manager , Patient Support Data Intelligence is responsible for process improvement, technology,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... relevant processes. Ensures alignment of training processes to corporate & quality systems. Responsible for maintaining Standard Operational Procedures (SOPs) for… more
- Cepheid (Miami, FL)
- …assessment to identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance .This position is part of the ... Audit Program (MDSAP) participating regulatory authorities Provide cross-functional compliance support for global QMS and Intracompany Quality Agreement… more
- Leica Biosystems (Miami, FL)
- …reports to the Manager , Quality Assurance and is part of the Quality Assurance and Regulatory Compliance Department located in Richmond, Illinois and ... Danaher Business System which makes everything possible.The Senior Histotechnician, Quality Control, is responsible for developing and implementing testing,… more
- BioAgilytix (San Diego, CA)
- …and Formulation Chemistry departments. This role oversees daily laboratory operations, scientific quality , and regulatory compliance across both functions, ... and ongoing training for department staff.Develop and maintain SOPs in compliance with regulatory requirements.Drive innovation through evaluation and… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to… more
- Merck & Co. (Durham, NC)
- … compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).- ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
