- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational… more
- American Honda Motor Co Inc (Marysville, OH)
- …Implementation:* Develop, implement, and maintain governance policies and procedures ensuring compliance with all legal and regulatory requirements.* Ensure ... policies are communicated effectively across the organization.* Monitor compliance with policies and recommend improvements.* Proactively review the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for US, EU and Company Core documents as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Windstream (Columbus, OH)
- …is counted weekly. Maintain daily metrics of all construction yard operations and review actual metrics to applied standards for the operations. Coach and develop ... Occasionally: 0-33% Types of Driver's License Required: Driver's License Our Benefits: Medical , Dental, Vision Insurance Plans 401K Plan Health & Flexible Savings… more
- BioAgilytix (Durham, NC)
- …Computer System Validation Status listing and the Master Equipment listing Assist during regulatory agency and sponsor inspections Review and approve site change ... that facilitates organizational success and meets business needs.Essential Responsibilities Review and approve equipment work orders Maintain equipment in site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThe Quality Compliance - Lead Auditor CAR-T is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies/ Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...and regulators.Ensure a process is in place for routine review of regulatory documents such as IB,… more
- Novo Nordisk Inc. (Atlanta, GA)
- 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Merck & Co. (Upper Gwynedd, PA)
- …leading edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other ... Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates...regulatory working teamsSuccessfully collaborate and lead resolution of regulatory , reputational (ie public relations), compliance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data information from critical manufacturing steps process and authoring Annual Product Review as per internal procedures and current regulatory requirements ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GMP Compliance Programs to assure product quality, integrity and compliance with regulatory guidelines and internal/global standards and procedures. ... of Standards and Procedures (SOPs) and Training Activities: Responsible for development and review of procedural documents that set compliance in QA GMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... with cross functional teams and various departments to include Marketing, Medical Affairs, Regulatory Affairs, Supply Chain Technical Operations, Pharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to achieve marketing's goals. Learn the core fundamentals of Medical Accuracy Review and Medical Review in an assigned therapeutic area(s). Participate ... About the Department The Clinical, Medical and Regulatory (CMR) department at...ensure that assigned programs are funded and executed in compliance with these guidelines. Participate in the review… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory … more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of those functions. Prepares legal documents such as contracts, correspondence (eg, to regulatory agencies), both independently and for review , approval, and use ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...school experience required- 4 or More Years experience in regulatory , compliance , and legal matters relating to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance : Understand study conduct from supply chain/drug ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
