- 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. (Rahway, NJ)
- …limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead .Develops worldwide product regulatory strategy to optimize label ... growth mindset. The Director, Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their assigned products, in order to optimize… more
- Merck & Co. (Rahway, NJ)
- …for someone with a growth mindset.Position Description: The Senior Director, Global Regulatory Lead , is responsible for development and implementation of ... worldwide regulatory strategy for their assigned projects in...all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and… more
- Merck & Co. (Rahway, NJ)
- …ResponsibilitiesLead/contribute to device development, design controls and risk management strategy for the assigned projects.- Lead the implementation and/or ... approaches within Device Development and with external suppliersUnderstand and apply regulatory / compliance requirements relative to design controls and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts. ResponsibilitiesLeads ... Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management and performance of CRO; Participates in creation of developmental and regulatory strategy ; Drafts protocol profiles and sections of key submission ... Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy : Clinical study leader (CSL) or major… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management and performance of CRO; Participates in creation of developmental and regulatory strategy ; Drafts protocol profiles and sections of key submission ... matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy : Clinical study leader (CSL) or major… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.Operational Strategy : Develop ... Medical teams as well as alliance partners, promoting a cohesive team approach. Regulatory and Safety Compliance : Understand study conduct from supply chain/drug… more
- Merck & Co. (Rahway, NJ)
- …and implement robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage ... the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all...They will also have responsibility for the end-to-end Upgrade strategy from roadmap to execution for the entire SAP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and ... Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ensure the adherence to the Quality Manual. Responsible ... the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for the creation...the right QA assessment and looking for the best strategy to avoid any impact for commercial and investigational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy ; Develops biomarker strategy ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… 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 ... and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop a team whose roles include… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support secondary customer ... and for all Product Launch, Sales, and POA Meetings. Take the lead in "Train-the-Trainer" programs when rolling out assigned customers training programs and… more
- Merck & Co. (Rahway, NJ)
- …our alliance partner and internal cross functional team membersSupport the Global Asset Lead to develop the Integrated Business Strategy by actively synthesizing ... including product development team, target product profile development, global regulatory filing strategy , launch readiness reviews, organized customer… more
- Merck & Co. (Rahway, NJ)
- …of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering… more
- Eisai, Inc (Nutley, NJ)
- …align communications and strategies across the brand's target audiences and to ensure regulatory /legal requirements are met. The SPM will lead efforts on ... on brand initiatives and programs.Participate in Medical, Legal, and Regulatory approval process for promotional programs.Monitor products, marketplace, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory ... and manage relationships with contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesDevelops metrics to… more
