-Cola Company Innovation strategy. · Provide regulatory affairs expertise and guidance to the system to identify solutions... to regulatory issues that can impact the Innovation pipelines. · Establish Global regulatory strategies to gain government...
. Potentially manage other RaDS architecture and engineering team members. Ensure ongoing compliance with regulatory safety, Good... diverse environment. CoM spans from the early discovery and characterization of matter through labeling of clinical supplies...
, etc.) and liaise with Regulatory Legal and Litigation as appropriate Providing legal counsel and education on FDA labeling... 3 development planning (patient reported outcome plans, key market regulatory needs, CT material sourcing, drug...
and Diagnostic Radiopharmaceutical practice, workflow, patient care, reimbursement, regulatory issues as well as the benefits of PET... or experience in Theranostics radioactive labeling preferred but not required. · Ability to manage u, down and in all directions...
oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements... deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR) Essential Functions: Manages all medical...
oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements... deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR) Essential Functions: Manages all medical...
company standards to meet regulatory and compliance guidelines; plans the selection of vendor that will support the long-term... and regulatory standards; provides strategic direction and signs off on procurement budgets, and directing the strategic planning...
meetings, packaging and labeling. In addition, responsible for facilitating transition from drug development to commercial..., review and approve external and internal reports and other documentation required by regulatory agencies, customers...
, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents... study design, execution and interpretation of results. Serves as the medical authority on the global product labeling team...
as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad hoc member... regulatory documents where necessary with supervision. This position conducts regulatory risk assessment and recommends...
offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured... global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique...
of the technical and procedural aspects of laboratory tests. The technician maintains awareness and complies with regulatory... and understands basic physiology recognizing appropriate test selection and abnormal test results. Under Medical Director supervision...
: Job Responsibilities Regulatory Compliance and Quality: Employees are obligated to uphold strict compliance with all regulations... and Safety Health Administration (OSHA), The Joint Commission (TJC), and other regulatory bodies. This includes active...
to existing programs. Advise and represent Company during regulatory actions. Review and develop work and site plans. Conduct... unusually hazardous operations, chemicals or conditions; Audit products to assure Hazard Communication labeling system...
of our patients, manufacturing teams, and quality teams. As part of the Packaging Development, you will report to Director, Packaging... Development and collaborate with Quality, Mfg, Regulatory, R&D, Clinical, Legal, and external partners including testing...
. This is an individual contributor role which will report to the Associate Director, Clinical Supply Chain, and be located in the Waltham... from Technical Operations, Clinical, and Regulatory. Author, review, and/or approve relevant clinical and technical documents...
for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more information, please visit... Sales Manager or Zone Sales Director and is the primary sales support resource for the Company and its sales team...
of specimens within guidelines.Follows protocol in labeling pour-offs.Stores specimens under appropriate conditions as quickly... personnel as delegated by medical director.Teaches procedure to students, peers, and new employeesEnsures that QC is tested...
Standards of the Laboratory, Corporation, Regulatory and Accrediting Agencies. SPECIFIC ACCOUNTABILITIES: Performs basic... Laboratory, Corporation, Regulatory and Accrediting Agencies. Proves competent in the laboratory by passing all competency...
, menus, recipes, equipment, and food safety and sanitation Monitor the living areas and programming area for regulatory... compliance regarding but not limited to food temps, refrigerator temps and proper labeling of food. Work in conjunction...