- Merck & Co. (Rahway, NJ)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance , Regulatory Documents {+ 4 ... protocol in collaboration with Data Management/Programming. Collaborating cross-functionally to monitor clinical data -to ensure quality , completeness , and… more
- Merck & Co. (Rahway, NJ)
- …key partner organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to ... Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement,… more
- Merck & Co. (Rahway, NJ)
- …US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders ... contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function...implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory … more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit...Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Merck & Co. (Upper Gwynedd, PA)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... Mentorship, Neuroanatomy, Pharmaceutical Development, Pharmacovigilance, Psychiatry, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality , CSPV, Clinical Operations, Clinical Development, RA CMC) to keep ... years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years… more
- Eisai, Inc (Nutley, NJ)
- …ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study ... of end-to-end clinical trials with the utmost compliance and quality consistent with Good ...and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and… 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
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates clinical … more
- Merck & Co. (Rahway, NJ)
- …solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality , Regulatory , Operations, Non- clinical , Clinical , and ... / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to...having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of… more
- Merck & Co. (North Wales, PA)
- …Process Improvements, Project Information Management, Project Management, Project Planning, Regulatory Compliance , SAS Macros, Social Collaboration, Software ... quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory , Statistical Programming, Data Management and other ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or… more
- Eisai, Inc (Raleigh, NC)
- …QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh facility. ... This position is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to the ... with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings… more
- Formation Bio (New York, NY)
- …early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our ... development, formulation, analytical methods, and technology transfer to manufacturing sites. Regulatory Compliance & Submissions Ensure all CMC activities… more
- Merck & Co. (Rahway, NJ)
- …operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ... Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations.Current… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QualificationsMust have at least 7 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement ... in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at least 4 or more years proficiency in ICH GCP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... strategies and tactics that will Improve strategic planning Expand and improve the quality of clinical research Increase accuracy of medical and marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.Ensures ... disciplines and cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position… more
