- Merck & Co. (Rahway, NJ)
- …with a drug-device product. - A minimum ten (10) years of industry / CMC regulatory experience (5 years with an advanced degree) in pharmaceutical or combination ... Capability, People Leadership, Policy Implementation, Project Management, Project Tasks, Regulatory Affairs Compliance {+ 4 more}-Preferred Skills:Job Posting… more
- Merck & Co. (Rahway, NJ)
- … Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Compliance {+ 5 more}-Preferred Skills:Job Posting ... our company's Research Division. Our mission is to serve as a trusted regulatory center of excellence and lead successful interactions with FDA regarding select US… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pharmaceutical or medical device/pharmaceutical combination product experience and actual regulatory experience Advanced knowledge of pertinent FDA regulations ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position Responsible for leading process, reporting and compliance related activities for US Talent Acquisition. Responsible for oversight of ... related to US Talent Acquisition. Ensures utilized solutions are compliant with regulatory requirement and advises on the same. Ensures Talent Acquisition functions… more
- Genmab (NJ)
- …and protocol deviations and is a key driver for inspection readiness, regulatory compliance , and successful data submissions.The Associate Director will lead ... or contribute to initiatives that improve operational efficiency, inspection readiness, and regulatory compliance .Act as a Data Standards or Clinical Systems… more
- Aequor (Thousand Oaks, CA)
- …of equipment in area of expertise. 15. Extensive knowledge and application of SAP Quality Management (QM) Module 16. Advanced skills in solving complex problems. ... possible remote role Summary: Under general direction, functions as the Specialist Quality Control working at the Corporate QC Center. Description: Job Details:… 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the … 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 ... and from different disciplines and cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for Legend Biotech.Lead and direct qualification activities to meet company goals, quality , and regulatory objectives. Qualification team will consist of ... managing external resources and some internal resources.Ensure safety, quality , and compliance is the main goal for all new and existing qualification… 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
- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams… more
- Merck & Co. (Rahway, NJ)
- …compliant, collaborative, and innovation-focused work environment.Builds a culture of quality and compliance through training, oversight, and ... ethics committees, and internal auditors in conjunction with CCQM, compliance , Regulatory , Pharmacovigilance (PV) and Medical Affairs.Responsible and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelps improve metric ... focused on an EHS first mindset, a Right First Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Eisai, Inc (Raleigh, NC)
- …line extensions or site manufacturing changes in collaboration with Product Quality , Regulatory Affairs, and Technical Operations.Establish productive business ... (SCM) Unit is accountable and/or responsible for providing an uninterrupted supply of quality products to patients and DCU customers in their respective regions. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review ... and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and ... analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and… more
- Merck & Co. (Rahway, NJ)
- …(GCD) regional office. Additionally, there are important interactions with, inter alia , Quality Assurance, Finance, Regulatory , Clinical Supplies and legal in a ... - Cluster Directors, and their respective staff. Ensure that compliance , quality and timeline - objectives are...skills are an added advantage (eg MBA) Preferred: An advanced graduate degree (eg, an MD, PhD, Pharm D,… more
- Merck & Co. (Upper Gwynedd, PA)
- …leadership of cross functional teams compromised of Global Supply Chain, Global Regulatory Affairs, Labeling, Material Master Data, Finance, Quality , Transfer ... business processes, product physical & financial flows, and awareness of regulatory , quality , and technical processes/ requirements.Primary activities include,… more
