- Novo Nordisk Inc. (Plainsboro, NJ)
- …on clinical research documentation, regulatory requirements, Good Clinical Practice ( GCP ), and medical affairs procedures Develop training needs assessments to ... Develop and deliver training on regulatory guidelines including FDA, EMA, ICH- GCP , and other global regulatory requirements Coordinate mandatory compliance training… more
- Merck & Co. (Rahway, NJ)
- …the candidate be responsible for the conduct of Good Clinical Practice ( GCP ) studies, and occasionally Good Laboratory Practice (GLP) studies. The Associate ... each study.Ensure that the study is conducted according to legal requirements, GCP , and the applicable internal policies and procedures.Prepare the Final Study… 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
- Merck & Co. (North Wales, PA)
- …knowledge of clinical trial operations Working knowledge of ICH and GCP guidelines Exceptional communication skills, with the ability to communicate with ... Data Validation, Decision Making, Ethical Standards, Good Clinical Practice ( GCP ), Organizational Alignment, People Leadership {+ 2 more}Preferred Skills: Current… more
- Formation Bio (New York, NY)
- …Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices ( GCP ), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The ... preferred. Strong working knowledge of global regulatory requirements, including GMP, GCP , and ICH guidelines. Expertise in Quality Management Systems (QMS).… more
- Genmab (NJ)
- …of Health Authority requirements and guidelines and any updates within the GCP area.Experience with MS Office and other (relevant) systems/tools.Attributes of a ... motivated by working in a fast-paced, ambiguous environment.Strong understanding of ICH- GCP , the development process and trial operations.Detail oriented and quality… more
- Insmed Incorporated (San Diego, CA)
- …automation, reporting, and data exchange solutions.Ensure all programming solutions comply with GCP , 21 CFR Part 11, and CDISC ODM Standards.Data Quality & ... Compliance: Ensure EDC systems comply with regulatory requirements (eg, FDA, EMA, ICH- GCP ) and company SOPs.Perform user acceptance testing (UAT) and validation of… more
- Merck & Co. (Rahway, NJ)
- …Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices ( GCP ) is highly desirable. Preferred Experience and Skills: Proficiency in using ... supply chain management systems and software, including experience with ERP systems (eg, SAP), demand planning tools, and inventory management systems. Familiarity with data analytics/visualization software. Familiarity with Good Manufacturing Practices (GMP)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP , GPV, GPEP, Data Protection, and other local regulatory requirements ... proactive representation of Quality professionals in strategic project teams and GCP discussions, contributing to the broader success of Medical Affairs… more
- Eisai, Inc (Durham, NC)
- …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
- Merck & Co. (Rahway, NJ)
- …Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices ( GCP ) is highly desirable. Preferred Experience and Skills: - Results-orientation with ... the proven ability to execute on collaborative projects and develop subject matter expertise Knowledge of order management, supply chain operations and document control #eligibleforERP GCScareers GCScareer25 #PSCS #VETJOBS Required Skills: Adaptability,… more
- Merck & Co. (Rahway, NJ)
- …- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices ( GCP ) is highly desirable. - Preferred Experience and Skills: - - Results-orientation ... with the proven ability to execute on collaborative projects and develop subject matter expertise-- - Knowledge of order management, supply chain operations and document control.- #MSJR #eligibleforERP GCScareer25 GCScareer #PSCS Required Skills: Adaptability,… 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
- 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 ... Capture/related applications and industry standards, and advanced skills partnering with CROs and other third-party vendors. He/She will have excellent verbal/written skills, analytical, organizational, and people management skills and collaborates effectively… more
- Merck & Co. (Rahway, NJ)
- …or biotechnologyKnowledge of regulatory aspects of pharmaceuticals including GLP, GCP and GMPAbility to manage multiple projects, including budgets, contracts, ... and timelinesAbility to independently plan, recommend and complete research programsExcellent communication and interpersonal skillsEffective creator of executive level presentations and documentsExperience in preparing patent applications in support of patent… more
- Aequor (Thousand Oaks, CA)
- …standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP , GLP & GPvP) and other applicable regulations Manages and provides oversight ... of documents / records within the Quality Management System Oversight of process key performance indicators and metrics Manages external contractors providing services to the Digital QMS Working across teams managing prioritiesPreferred Qualifications: Strong… more
- Genmab (NJ)
- …research, metadata management, industry standards (CDISC), FDA & ICH, GCP , and related regulatory requirements Demonstrated experience managing multiple tasks, ... complex projects and working with cross functional teams delivering to project and portfolio timelines and metrics Strong verbal and written communication skills; independent and effective working in a multi-study, multi-disciplinary atmosphere in a matrix… more
- Aequor (South San Francisco, CA)
- …libraries like scikit-learn.Familiarity with cloud computing environments (eg, AWS, Azure, GCP ) or querying with SQL.Knowledge of architecture and building standards ... is a plus, but not required more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …leadership abilities, strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management systems.Preferred but Not Mandatory: Medical ... practice experience in respiratory medicine.Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability,… more
- Eisai, Inc (Nutley, NJ)
- …the Quality management system. This role is responsible for Good Clinical Practice ( GCP ) and for assuring the compliance of projects, products and programs with ... Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (eg EU Directives, US FDA, PMDA, ICH, and National regulations).In the current times, drug development is going through a significant transformation… more
