- Insmed Incorporated (San Diego, CA)
- …strategic direction with cross functional working groups to identify and mitigate GCP quality and compliance issues.Supports the evaluation and acceptability of ... Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical… more
- Aequor (Athens, GA)
- …and interpersonal skills. Previous experience in pharmaceutical industry and/or familiarity with GLP/ GCP /GMP compliance a plus. BBA or equivalent experience. ... Physically escort any visitors in the archive and ensure sign into the logbook. Manage the Chain of Custody procedures to ensure the integrity of all study documentation. Assists with client requests and document management. Performs other duties as assigned.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Project Management:Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP , GPV, GPEP, Data Protection, and other ... audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the… more
- Merck & Co. (North Wales, PA)
- …Compliance Program Development, Crisis Management, Cross-Cultural Awareness, Detail-Oriented, Global Compliance , Good Clinical Practice ( GCP ), IS Audit, Issue ... this role. Strategic duties involve providing proactive assessments of compliance culture and governance through input to the GRACS... culture and governance through input to the GRACS Compliance Council. This role also supports GRACS within our… more
- Eisai, Inc (Nutley, NJ)
- …of the Quality management system. This role is responsible for Good Clinical Practice ( GCP ) and for assuring the compliance of projects, products and programs ... clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality /CQA conducting a broad… more
- Eisai, Inc (Nutley, NJ)
- …of the Quality management system. This role is responsible for Good Clinical Practice ( GCP ) oversight, and for assuring the compliance of projects, products and ... operations/ data management or related area. 5+ years of experience in GCP auditing. Substantial experience in inspection management. Substantial experience with US,… more
- Genmab (NJ)
- …to corporate compliance policiesCurrent working knowledge of FDA, OIG, ICH, GCP , PhRMA Code, HIPAA and other compliance regulations and guidelines relevant ... to industry interactions with healthcare professionalsDemonstrated technical acumen including MS Office skills, ability to adopt and leverage multiple business applicationsFor US based candidates, the proposed salary band for this position is as… more
- Insmed Incorporated (San Diego, CA)
- …implementation of EDC systems to support clinical trials, ensuring data quality, compliance , and efficiency throughout the study lifecycle. The AD, EDC Programming ... support automation, reporting, and data exchange solutionsEnsure all programming solutions comply with GCP , 21 CFR Part 11, and CDISC ODM StandardsData Quality & … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic ... in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the management of PV… more
- Merck & Co. (Sacramento, CA)
- …standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilitiesPreferred Field-based medical ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …based on a sound knowledge of clinical research standards and GCP .Develop operational strategies for implementation of clinical studies regionally/globally in ... and review of regional / global policies and procedures. Ensure compliance with all Company and Regulatory requirements.Work with outsourcing procurement management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of continuous improvement in ... tool(s).Perform monitoring and tracking of the signal workflow to ensure compliance with procedural documents.When required, assist the product safety teams in… more
- Merck & Co. (Rahway, NJ)
- …modules, monitoring processes, and systems. Maintain training materials in compliance with applicable SOPs, policies, and regulatory requirements. - Defines ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …(TPP) development, due diligence projects, and clinical-regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design ... and execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop study… more
- Merck & Co. (Rahway, NJ)
- …or biotechnologyKnowledge of regulatory aspects of pharmaceuticals including GLP, GCP and GMPAbility to manage multiple projects, including budgets, contracts, ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for projects/studies. This individual has sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data ... the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures inspection readiness of all data management… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** GCP Quality Compliance Manager** **What you will do** Let's do this! Let's ... Provide hands-on support to the Senior Manager/Associate Director in ensuring procedural compliance with GCP standards and other regulatory requirements across… more
- ThermoFisher Scientific (Wilmington, NC)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Job Summary** As the GCP Compliance and Process Lead at Thermo Fisher Scientific, ... field + Solid knowledge of drug development, clinical trial management, and/or GCP compliance processes + Proven awareness of sponsor oversight requirements… more
- BeOne Medicines (Tallahassee, FL)
- …role (as Lead or Co-auditor) who is responsible for independently overseeing and conducting GCP audits, to ensure compliance with GCP regulations and ... Audit : Perform on-site or remote audits (routine, for-cause/directed); Evaluate compliance with GCP regulations, internal quality standards, and relevant… more
- ThermoFisher Scientific (Wilmington, NC)
- …**Job Description** **Job Description** Join Thermo Fisher Scientific Inc. as an outstanding GCP Compliance Oversight Manager and play a crucial role in ensuring ... well as team performance and understanding on evaluated processes. + Represent GCP Compliance in meetings as needed. + Performs other duties as assigned.… more
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