- Merck & Co. (Rahway, NJ)
- …to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on ... and solutions to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory … more
- Merck & Co. (Rahway, NJ)
- …processes/ methods in conformance to all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that ... Job DescriptionThe Associate Director , ESQL is responsible for all activities at...EQA and Division in specific Quality systems, technology platforms, regulatory expectations and/or EE management, and can represent the… more
- Merck & Co. (Rahway, NJ)
- …and guidelines for secure cloud-native architectures and practices, ensuring compliance with industry standards and regulatory requirements.Stay up-to-date ... with emerging security technologies, industry trends, and vulnerabilities, and proactively identify areas for improvement and innovation.Requirements:Bachelor's Degree in Computer Science, Information Security, or a related field required. Advanced Degree… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe have an exciting Director opportunity to join our global oncology marketing team focusing on co-commercialization of an Antibody Drug Conjugate a ... alliance global brand team, joint product development team, and joint regulatory / labeling discussionsSupport alliance forecasting and scenario planning by aligning… more
- Merck & Co. (Rahway, NJ)
- …and adhere to CFR, GMP, and data integrity regulations to ensure compliance with regulatory requirements.Develop and maintain SDLC documentation.Actively work in ... on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot… more
- Merck & Co. (Rahway, NJ)
- …vaccine programs.Interact with cross functional scientists including, Statistics, Clinical, Regulatory , QP2, CSRM, Data Management and Statistical Programming to ... appropriate and consistent application of SOPs, standards and quality and compliance measures.Engage with cross functional stakeholders to identify areas for… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to ... educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …providing direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory ... awareness of best practices for reproducible data science, global regulatory requirements, internal guidelines and Standard Operating Procedures (SOPs)- Ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key ... Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation ... of developmental and regulatory strategy; Drafts protocol profiles and sections of key...listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, develops biomarker strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this workPossesses in-depth ... knowledge of regulatory authority's requirementsTypically has administrative responsibility for recruiting, retaining, developing, and managing employeesGuide career… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …providing direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory ... Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert… more
- Eisai, Inc (Nutley, NJ)
- …customer journeys and strategies across target audiences as well as ensure regulatory /legal and compliance requirements are met.This role requires strong ... If this is your profile, we want to hear from you. The Associate Director , Omnichannel Marketing and Media position reports to the Senior Director , Omnichannel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has leadership and ... in the pharma industry, (iii) supporting consistency, coherence, and compliance , (iv) establishing area-relevant standards, (v) encouraging innovation.Build strong… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 ... knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
