- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas… 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
- Merck & Co. (Rahway, NJ)
- …supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply ... the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities… 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)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and performance management… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Merck & Co. (North Wales, PA)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology, Prioritization, Regulatory Compliance , Regulatory Documents, Rheumatology, ... study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment… more
- Merck & Co. (Rahway, NJ)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance , Regulatory Documents {+ 4 ... (e . g . , ICF documents/ amendments); Partners with the Study Manager on study deliverables. Ensuring CRF design supports data collection in alignment with… 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. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior-level and… 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
- Merck & Co. (Durham, NC)
- …The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the ... an inclusive team culture including significant interaction with operations, quality , automation, technology, and other groups as required.Key Duties:Ability to… more
- Merck & Co. (Durham, NC)
- …an inclusive team culture including significant interaction with operations, quality , automation, technology, and other groups as required.Key Duties:Ability to ... guided by policies, procedures and business plan; receives guidance from manager .Contributes to the performance and results of the department.Identifies and resolves… more
- Merck & Co. (Durham, NC)
- …Durham sites.- This includes Energy Center, Vaccines Manufacturing and Bulk Facilities, Quality Labs, and Maintenance and Material Storage Facility (MMSF). At times, ... guided by policies, procedures and business plan; receives limited guidance from manager .Prepares routine PMs for execution and ensures materials, tools and permits… more
- Twist BioScience (South San Francisco, CA)
- …that all products processed, packaged, stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this ... by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. ... and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees...of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires… more
- Fort Duncan Regional Medical Center (Eagle Pass, TX)
- …and compliance . Ensure adherence to TJC, CMS, and state regulatory standards. Participate in interdisciplinary care planning meetings and discharge rounds. ... and oversee the hospital's case management department, ensuring patients receive high- quality , efficient, and coordinated care from admission through discharge and… more
