- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance , GCP /Document Audits supports end-to-end audit activities per audit ... provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that evidence is… more
- 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
- Eisai, Inc (Nutley, NJ)
- …utmost compliance and quality consistent with Good Clinical Practice ( GCP ). This individual must effectively balance strategic vision with hands-on operational ... components. Key Responsibilities:Manage and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement… 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
- Merck & Co. (North Wales, PA)
- …the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing priorities with good planning, ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage multi e competing priorities with good -planning , ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (North Wales, PA)
- …Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing priorities with good-planning, ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (NJ)
- …operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilitiesPreferredField-based medical experienceResearch ... 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)
- …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. (Chicago, IL)
- …field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilities.Location: This is a remote ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices ( GCP ) is highly desirable. - Preferred Experience and Skills: - - Proficiency ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (North Wales, PA)
- …the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing priorities and effectively ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …management. - Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices ( GCP ) is highly desirable. - Preferred Experience and Skills: - - - ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Merck & Co. (Rahway, NJ)
- …of Good Manufacturing Practices (GMP) and Good Clinical Practices ( GCP ) is highly desirable.-Preferred Experience and Skills: --Results-orientation with the ... consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents… more
- Aequor (Thousand Oaks, CA)
- …and ensure smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance: Ensure all data management activities comply with ... regulatory standards (eg, FDA, EMA, ICH- GCP ). Cross-Functional Collaboration: Collaborate with clinical teams to ensure data collection aligns with study objectives.… more
- Twist BioScience (South San Francisco, CA)
- …technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the full Software Development ... and data visualization capabilities to support operational decision-making and quality reviews. Compliance & Validation: Ensure our custom MES solutions comply with… more
- Eisai, Inc (Nutley, NJ)
- …and in accordance with standard operating procedures (SOP), good clinical practice ( GCP ) and specific country regulations such as site and vendor selection, ... the vendor reconciliation processAdhere to financial standards, guidelines and compliance requirements Technical Competencies: Functional development for resource planning.… more
- Alira Health (Framingham, MA)
- …strategies for sites. Maintains regular contact with study sites to ensure protocol/ GCP compliance , assesses patient accrual rates, and responds to sponsor ... Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance , address site questions, and assist with study recruitment, site training,… more
- Kaiser Permanente (Panorama City, CA)
- …to compliance and privacy/ confidentiality requirements and standards. Adheres to GCP and compliance regulations for clinical trials. Assists with and/ or ... oversees quality assurance of study activities; ensures quality data. Acquires and maintains knowledge of KP systems and databases. Identifies, recommends and implements solutions to study issues. May interface with IRB and/ or draft portions of IRB protocols,… more
