- Merck & Co. (Rahway, NJ)
- … precedence and competitive intelligence to facilitate development of regulatory strategy .- Assist the global regulatory lead in authoring of ... collaboration skills and will work closely with a global regulatory lead (s) to help develop and implement...all aspects of planning and implementation of a global regulatory strategy and regulatory submissions… more
- Merck & Co. (Rahway, NJ)
- …Affairs, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory ... to define and implement user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for electronic… more
- Formation Bio (New York, NY)
- …Affairs lead is responsible for developing and directing the regional regulatory strategy , objectives, policies, and programs pertaining to developing and ... marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global...registration and life cycle support and the leadership of regulatory strategy for projects that are currently… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director and Global Lead , Patient Advocacy & Strategic Alliances position resides in the Value & Implementation (V&I) organization, ... Affairs as well as Outcomes Research. This position executes the patient engagement strategy in alignment with our company priorities. This leader is innovative and… more
- Eisai, Inc (Nutley, NJ)
- …with a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and executes outsourcing ... across the organization. Collaboration is central, working closely with Finance, Legal, Regulatory & Compliance , IT Security, and Clinical teams to align… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development & ... Responsibilities: Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from… more
- Merck & Co. (Rahway, NJ)
- …executive level and build cross-functional partnerships.Solid understanding of security, compliance and regulatory requirements relevant to payments (PCI-DSS) ... Job DescriptionWe are seeking a seasoned IT SAP Finance Director to lead the design, delivery and continuous improvement of SAP Finance solutions across our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Strategy and Study Execution while exhibiting leadership qualities.Responsibilities- - Lead the core study team while project managing and collaborating with ... areas centered around rare diseases and immune disorders. SummaryThe Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team… more
- Merck & Co. (Rahway, NJ)
- …for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial product.-The specific role will ... DCT deliverables including - robust processes & analytics, an integrated control strategy , successful tech transfer packages, filing and approval, and a robust… more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization and manufacturing operations- Strong understanding of regulatory requirements- Ability to lead without authority, build trust, ... be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …content of any documents sent to regulatory authorities. Provides compliance metrics to management, as needed. Lead continuous improvement around development ... across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a...to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance… more
- Merck & Co. (Rahway, NJ)
- …Expertise in cell culture commercialization and manufacturing operations Understanding of regulatory requirements Ability to lead without authority, build trust, ... be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing… more
- Merck & Co. (Rahway, NJ)
- …and stakeholder engagement for our Company communications teams. Key Responsibilities Product Strategy & Roadmap Lead and manage IT applications supporting ... and communications stakeholders to refine, scope, and deliver technology solutions. Regulatory & Compliance Ensure technology solutions for communications comply… more
- Merck & Co. (Rahway, NJ)
- … Lead will drive/execute the patient engagement and advocacy strategy in alignment with company priorities, work cross-functionally with various internal ... Job DescriptionRole SummaryThe Director Scientific Patient Engagement Lead is responsible for developing and implementing a global headquarters strategic patient… more
- Formation Bio (New York, NY)
- …of Quality Assurance are to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and ... you will establish and manage the organization to ensure our organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good… more
- Merck & Co. (Rahway, NJ)
- …including method development and validation, internally or externally, per design verification strategy . Lead strategy and execution of accelerated and real ... Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our… more
- Merck & Co. (Rahway, NJ)
- …Competencies Required: Strong cross-functional leadership across teams, eg, marketing, IT, compliance , and analyticsProven ability to lead scaled teams with ... design, identity architecture, and digital personalization strategiesExperience with content strategy , campaign platforms, omnichannel compliance (DAM, Consent… more
- Merck & Co. (Rahway, NJ)
- …Networking and Partnerships, Program Management, Quality Management Systems (QMS), Quality Strategy , Regulatory Compliance , Risk Management, Stakeholder ... DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a...core member of the Value Chain Management Team, guiding strategy , ensuring compliance , and enabling manufacturing excellence… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... strategic direction for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Center of Excellence… more
- Formation Bio (New York, NY)
- …clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving ... clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating… more
