- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP /Document Audits supports end-to-end audit activities per audit program of GxP ... document reviewMust have at least 4 or more years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials… more
- Insmed Incorporated (San Diego, CA)
- …and maintain a risk-based and scientific-based quality system to support GCP .Oversee regulatory agency inspections and vendor audits.Ability to ensure that a ... are conducted, and reports written according to SOPs and regulations.Oversee GCP activities (including internal or external audit observations and development of… more
- Merck & Co. (Chicago, IL)
- …operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilities.PreferredField-based medical experienceResearch ... Medicine, Cross-Functional Teamwork, Dermatology, External Engagement, Good Clinical Practice ( GCP ), Healthcare Delivery Systems, Healthcare Education, Hospital Medicine, Immunology,… 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, ... Communication, Data Analysis, Dermatology, Drug Development, Ethical Standards, ICH GCP Guidelines, Life Science, Medical Writing, Motivation Management, Ophthalmology,… 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 , ... Critical Thinking, Data Analysis, Drug Development, Ethical Standards, ICH GCP Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization,… 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, ... Cross-Functional Teamwork, Data Analysis, Drug Development, Ethical Standards, ICH GCP Guidelines, Identifying Risks, Life Science, Medical Writing, Motivation… more
- Merck & Co. (Chicago, IL)
- …field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilities.Location: This is a remote ... Studies, Clinical Trials Operations, Dermatology, Gastroenterology, Good Clinical Practice ( GCP ), Inflammatory Bowel Diseases, Key Opinion Leaders, Medical Affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …marketed products; required4 or More Years Knowledge of Good Clinical Procedures ( GCP ) and Good Pharmacovigilance Procedures (GVP) required4 or More Years Knowledge ... databases; preferred4 or More Years Familiarity with Good Clinical Procedures ( GCP ) and Good Pharmacovigilance Procedures (GVP), PharmD, RN, or master's degree… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated clinical trials, clinical safety, pharmacovigilance Must have proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of ... clinical trials. Ability to provide interpretation and guidance for internal and external customers on GxP related regulations / guidelines (eg, FDA, EU, ICH) and company procedures and policies. Competencies:Professional or other related function and… more
- Eisai, Inc (Nutley, NJ)
- …Quality management system. This role is responsible for Good Clinical Practice ( GCP ) oversight, and for assuring the compliance of projects, products and programs ... 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)
- …adherence 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 follows:$0.00… more
- Eisai, Inc (Nutley, NJ)
- …the utmost compliance and quality consistent with Good Clinical Practice ( GCP ). This individual must effectively balance strategic vision with hands-on operational ... and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement strategic vision and hands-on… 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 ... delegate and assign activities to meet the business needsAbility to develop short and mid-range project plans that are realistic and effective at meeting goals.Strong analytical skills to drive operational milestones Influence opinions and decisions of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical and safety databases, preferredFamiliarity with Good Clinical Procedures ( GCP ) and Good Pharmacovigilance Procedures (GVP) preferred Daiichi Sankyo, Inc. ... is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age,… more
- Twist BioScience (South San Francisco, CA)
- …familiarity with containerization (Docker, Kubernetes), CI/CD, and cloud platforms (AWS, GCP , or Azure).Experience with monitoring, logging, and alerting tools for ... bioinformatics workflows.Cross-Functional Collaboration & Support:Ability to work closely with Field Application Scientists, translating field needs into scalable computational solutions.Strong troubleshooting skills and the ability to identify, debug, and… more
- Twist BioScience (South San Francisco, CA)
- …software architecture certifications.Experience with cloud platforms (eg, AWS, Azure, GCP ) and DevOps practices.Direct experience participating in regulatory audits ... (eg, FDA inspections) specifically related to custom software and CSV.Experience with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom reporting dashboards.About Twist BioscienceTwist… more
- Taiho Oncology (FL)
- …disease states which are of interest to Taiho Oncology, study methodology, GCP , clinical information, and product data Demonstrate full knowledge of and ability ... to execute on approved medical platforms/strategies and Sr. Manager, Medical Field initiatives Serve as technical/scientific subject matter resource to Taiho commercial personnel, if requested Research Support: At the local level, identify opportunities for… more
- Genmab (NJ)
- …highly preferred.Solid understanding of clinical development and regulatory frameworks, including GCP and ICH guidelines.Proficiency with writing tools such as MS ... Word, EndNote, document management systemsAbility to interpret and summarize tabular and graphical data presentations.Experience with AI tools preferredAbout You - additional qualities you bring to the tableYou are capable of working on multiple tasks and… more
- Eisai, Inc (Nutley, NJ)
- …with other Health Authorities the CDE. Actively participates in Health Authority GCP inspections (eg, FDA, EMA, PMDA) including responding to observations and ... development of corrective actions. Keep abreast of changes in the regulatory environment and implement necessary adaptations. Provide expert opinion, advice and strategic direction on emerging policy & intelligence matters. Ensure continued engagement,… 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, ... preparing clinical trial budgets. Ensures study is conducted within clinical trial protocols. Monitors progress and follows up with team members and line managers when issues develop. Implements and prepares the clinical development strategy as outlined by the… more
