- Merck & Co. (Rahway, NJ)
- … Affairs Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine ... as the single, accountable, global point of contact on those projects.Develops global regulatory strategy for their assigned products, to optimize labeling and… more
- Merck & Co. (Rahway, NJ)
- … Affairs Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine ... Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more company investigational… more
- Merck & Co. (Rahway, NJ)
- …strategic direction of the company's product pipeline and regulatory strategy .Drive operational excellence initiatives that improve quality, compliance , and ... and implement continuous improvement strategies for device quality and regulatory processes.Monitor and ensure compliance with global regulations… 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
- 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
- Eisai, Inc (Nutley, NJ)
- …assesses and provides objective risk assessments and guidance regarding Eisai's compliance with regulatory , organizational, and commercial requirements that ... compliance initiatives (strategic and execution).Assess and guide on compliance with regulatory , organizational, and commercial requirements.Define and… 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
- Merck & Co. (Rahway, NJ)
- …other parts of the AR&D organization in aspects of quality control and compliance . Your main responsibilities will include: - Strategy and Operational ... exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience...needs, which can include impact of the external business, regulatory , and compliance environment. Promoting our company's… 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
- Merck & Co. (Rahway, NJ)
- …of the following: process performance qualification, risk assessment, control strategy , process comparability reports, and/or regulatory submissions.Adaptability ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… 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
- Merck & Co. (Rahway, NJ)
- …modalities for clinical and/or commercial manufacturing would be idealExperience in regulatory compliance expectations across all phases of product development ... (SPD) team. The successful candidate will be expected to lead the team focused on the design of new...formulation and process development and document technical reports and regulatory filings. The successful candidate will be key in… 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)
- …support development, IND-enabling stability, commercial stability (PSS), and Design Verification (DV). Lead method tech transfer strategy and execution to ... stability, and Design Verification. This role involves leading the method tech transfer strategy and execution to internal and external GMP testing nodes in support… more
- Merck & Co. (Rahway, NJ)
- …for delivering a fully integrated stage-appropriate development and commercialization strategy which yields the target commercial product.-Leads the cross-functional ... risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure high quality data. Work closely with internal statistical programmer.Global strategy to Improve Drug Development: Primarily participates and may occasionally ... lead moderately complex biostatistical initiatives, with supervision, to improve...statistical methodologies.Some understanding of current drug development trends and regulatory environments.Sufficient programming skills in SAS and/or R and… 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
- Merck & Co. (Rahway, NJ)
- …Lung cancer for our Company's oncology business.- The Global Marketing Director will lead strategies and marketing efforts for Non-small Cell Lung Cancer (NSCLC) and ... thought leader engagements, medical symposia, webcasts, and speaker forumsLung Disease lead for the evolution of the organization's Early Detection / Screening… more
- Merck & Co. (Rahway, NJ)
- …contributor, shape and realize innovation across the Biologics' pipeline, strategy , and scienceAdvance the pipeline by collaborating with cross-functional teams, ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable purification processes for… more
- Merck & Co. (Rahway, NJ)
- …from individuals around the world.The future incumbent of this position ensures regulatory compliance and operational excellence by managing the DSR process ... on best practices and optimal DSR service models, ensuring process readiness for regulatory compliance .DSR Process & Technology: defines the plan for the global… more
