- Tris Pharma (Monmouth Junction, NJ)
- …direction for Clinical Quality Assurance Operations, ensuring compliance with regulatory standards and driving implementation and continuous improvement ... an immediate opening for a full-time permanent Director/Senior Director, Clinical Quality Assurance. This is a hybrid...maintain the GCP QA programs, policies, and SOPs.Ensure GCP compliance of clinical trials.Oversee and manage the… more
- Merck & Co. (Rahway, NJ)
- …GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes. This ... of GRACS, including training process standards and strategies to ensure optimal quality and compliance in GRACS business processes.Core Responsibilities may… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of ... sections of key submission documents; Point of contact for interactions with regulatory -agency clinical reviewing divisions on clinical matters; Represents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of ... sections of key submission documents; Point of contact for interactions with regulatory -agency clinical reviewing divisions on clinical matters; Represents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment… more
- Novo Nordisk Inc. (WA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... About the Department The Clinical , Medical and Regulatory (CMR) department...scientific integrity; regulatory and process compliance ) for monitoring and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with legal and compliance as required. Proactively collaborate with other GxP quality representatives and act as QA point person for US and EU Medical Affairs ... learned information flow based on read outs from audits, inspections, Quality Events, regulatory intelligence, effectiveness checks on process implementations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting ... the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of...independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements… more
- Eisai, Inc (NJ)
- …and management. Collaborates with study teams, legal, finance, clinical planning, compliance , clinical quality , data protection, IT security and other ... functions, as required. Ensures compliance of work product to SOPs, guidelines, work instructions...contract research organization or other relevant providers. Knowledge of clinical research process and regulatory environment Demonstrates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with Global QMS to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good ... technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of… more
- CHRISTUS Health (Alex, LA)
- …in-person environment of care rounding to medical practice sites assessing clinical quality and regulatory compliance Identifies practice gaps that may ... Description Summary: Reporting directly to the Manager of Clinical Quality , this position is the...rounding on practice sites to assess best practice in regulatory standards and quality and safety initiatives.… more
- Novo Nordisk Inc. (Philadelphia, PA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …or biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non- clinical , Clinical , and ... Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance : Understand study conduct from supply chain/drug ... execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical… more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non- clinical , Clinical , and ... pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, ... global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs,… more
- Merck & Co. (North Wales, PA)
- …clinical studies per our company's process es and standards to ensure compliance with internal policy, regulatory requirements, and health literacy principles ... informed of problems or unresolved issues that could affect compliance timelines or work quality - Building...clinical trial PLS and adapting to the changing regulatory environment as needed - - Education: - Bachelor's… more
