- Aequor (Thousand Oaks, CA)
- …degree and a minimum of 2 years of hands-on experience in document management, including workflow coordination and system administration. Proficiency with Viva or ... comparable document management platforms is required. Strong background in project...management of R&D controlled documents to ensure compliance with regulatory standards and internal quality procedures. This role emphasizes… more
- Christus Health (Beaumont, TX)
- …as promulgated by state and federal agencies, the hospital, and other regulatory entitiesPerforms all duties in a manner that protects the confidentiality of ... patients and does not solicit or disclose any confidential information unless it is necessary in the performance of assigned job dutiesPerforms other duties as assigned Requirements: Associate's Degree in NursingRN License in state of employment or compact… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... through demonstrated expertise in technical writing, including the authoring of procedures, regulatory or audit responses, process flows, and a variety of reports,… more
- Merck & Co. (Rahway, NJ)
- …and supply.A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a ... frictionless flow of data from source systems to regulatory documentation.- Under the guidance of dCMC Leadership, the Senior Specialist, Digital CMC Data Analyst,… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... to ensure integrity, accuracy, and completeness of GxP data-Participate in regulatory or internal QA audits-Monitor lab operations and quality metrics, identifying… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement ... and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... computer sciences, medical technology, business management, etc.-Responsibilities-Strong knowledge of document or training management systems. May also be involved… more
- Merck & Co. (Rahway, NJ)
- …and external stakeholders, representing your functional area on cross-functional teams. Document Your Impact:-Author essential regulatory and technical ... in late-stage process development, including viral clearance studies and regulatory submissions.Proficiency in statistical methods for design of experiments (DOE)… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings.- As the new facility will not be fully constructed and ready ... of laboratory processes and data to ensure compliance with existing regulatory regulation and departmental SOPs- Required Experience & Skills -Experience with… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... data. -May review data generated by others-Understand and apply regulatory /compliance/scientific requirements relative to their role-May publish and/or present… more
- Merck & Co. (Lower Gwynedd, PA)
- …utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. -As the AdVAnce facility will not be fully constructed and ... laboratory processes and data to ensure compliance with existing regulatory regulation and departmental SOPs-Required Experience & Skills-Experience with molecular… more
- Christus Health (Tyler, TX)
- …the Radiology Medical Director, understand patient assessment/treatment procedures, and document appropriate procedural information in the patient's medical record. ... management in determining methods and procedures for new tasks. Assists with regulatory compliance. May be asked to participate in educational presentations to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of ... PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly,… more
- Repligen (Waltham, MA)
- …supporting root cause investigations, and ensuring Repligen's supplier network meets regulatory and quality standards. This role is based in Waltham, MA, ... Supplier Change Notifications to ensure compliance with internal and regulatory quality standards.Coordinate cross-functional teams to assess and mitigate risks… more
- Monster (Houston, TX)
- …remittance processing, and service initiation), Consumer Operations, Marketing, Legal and Regulatory . Responsibilities: Perform and document Customer Care impact ... the effectiveness of business processes, conduct analysis, make recommendations, document processes, communicate those processes to the organization, and coordinate… more
- Merck & Co. (Rahway, NJ)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory , manufacturing, and Supply Chain to facilitate effective technical… more
- Merck & Co. (North Wales, PA)
- …effectiveness to the business and communicate suggestions for improvement Document needs for customization or localization of learning programsReview ... in medical/legal/ compliance (CRT) reviews-Understanding of the US and Global regulatory stages and requirements-Job Owner - Fully responsible for asset management… more
- Aequor (Irvine, CA)
- …and clinical customer complaints. Perform hands-on technical investigations and document results per established procedures and timelines. Performs hands-on ... requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices Minimum Requirements: Bachelor's Degree -… more
- Monster (Newark, DE)
- …with the CEO to take, transcribe, and distribute minutes, ensuring timely regulatory uploads and document retention. Coordinates domestic and international ... travel for the CEO, working with internal and external stakeholders including investors, regulators, and consultants. Submits expense reports, processes contracts and corporate documents, and supports legal and administrative tasks tied to committee and… more
- Repligen (Clifton Park, NY)
- …ensure a motivated and effective team environment Provide training in document -controlled manufacturing techniques. Approve shift schedules and vacation requests to ... production leads as required. Ensure compliance with GMPs, SOPs, and all regulatory standards that are carried out in accordance with Repligen's Quality Management… more
