- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance, ... to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and… more
- Aequor (Thousand Oaks, CA)
- …and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. Write or lead all aspects of the writing of ... FULLY REMOTE final BR - / hour Regulatory Writing Manager In this vital...of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance Strong… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …major programs or initiatives, and may function in a project leadership role Regulatory compliance : Ensures compliance with all Federal regulations, ... to the following: all units in Patient Safety, NNI GXP Support, NNI Legal, NNI Compliance , NNI Commercial, NNI Finance, Global Business Services (GBS), PV & GDP… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Operations Manager - Investigations and Compliance as part of the Technical Operations ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...be responsible for overseeing Operations related Investigations and general Compliance , as it relates to personalized cell therapy to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in-built controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. ... GxP and Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes… more
- Catalent (San Diego, CA)
- …Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance , and sound fiscal responsibility. The primary ... Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego,...include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of… more
- Merck & Co. (Rahway, NJ)
- …and updates country information in clinical and finance systems.Ownership of local regulatory and financial compliance . The position has a significant impact ... to make decisions independently with limited oversight from Sr.COM or manager .Requires strong understanding of local regulatory environment.Ability to… more
- Merck & Co. (Rahway, NJ)
- …with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align ... Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other...project management for assigned protocols in a country in compliance with-ICH/GCP and country regulations, Our Company policies and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations… more
- Eisai, Inc (Nutley, NJ)
- …Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with ... reports for the assigned product area, codes and enters information into the global safety database as requiredCreates and reviews individual and summary reports for… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for...- that impact the efficiency and effectiveness of own unit; Compliance - Responsible for creating and sustaining a culture… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … compliance with applicable Janssen standards, industry standards, and global regulations. Provide Quality Oversight for batch records, change controls, SOPs, ... Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one...multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for at least two global development projects that have been submitted to regulatory agencies preferred Travel Ability to travel up to 10% Daiichi Sankyo, Inc. is ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... reporting safety issues and completing corrective/preventative actionsDrive culture of compliance through actions, consistent quality-driven decision making, and coaching… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence… more
- Novo Nordisk Inc. (West Palm Beach, FL)
- …for effectively managing budget within targets Responsible for ensuring and tracking compliance with regulatory /legal mandates Review and audit direct reports' ... offer the chance to be part of a truly global workplace, where passion and engagement are met with...ability to lead through change. Relationships Internally, the Educator Manager (EM) reports to a Region Business Director (RBD)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the… 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
- Lundbeck (White Plains, NY)
- …be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative ... lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand… more
