- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Merck & Co. (Rahway, NJ)
- …Affairs, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory ... Job Description Associate Director , Regulatory Submissions Archive Operations -...and implement user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team.- The individual ... to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the… more
- Eisai, Inc (Nutley, NJ)
- …performance, and mitigate operational and regulatory risks. The Senior Director oversees vendor qualification, governance frameworks, and compliance with ... with a proven track record in inspection-facing roles and global regulatory compliance .Essential Functions Clinical Outsourcing Designs and executes outsourcing… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director , will report to the Animal Health Global Quality Compliance and Technical ... authority (particularly USDA-APHIS-CVB-IC and/or -PEL) as an inspector, product reviewer, compliance officer, other GMP/ regulatory role or Site Quality Head… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... the regional regulatory strategy, objectives, policies, and programs pertaining to developing...to all appropriate departments in Formation Bio to assure compliance with applicable regulations. Remains knowledgeable about current regulations… more
- Merck & Co. (Rahway, NJ)
- …Name Development, Process Improvements, Professional Presentation, Project Management, Regulatory Compliance , Strategic PlanningPreferred Skills: Current ... the brand while ensuring adherence to internal processes and regulatory guidelines.- To prepare for these launches, we are...for these launches, we are looking for an Associate Director (AD) to join our center of excellence.Description:-Under the… more
- Merck & Co. (Rahway, NJ)
- …Project Management Information Systems (PMIS), Project Planning, Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement {+ ... Office (PMO); and Administrative Professionals. Position Description/Summary: The GPAM Associate Director , Value & Implementation Project Manager (VIPM), is a core… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. ... as well as with all applicable regulatory requirements.Support GxP regulatory inspections as required.Support the local Compliance and auditing teams… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... Evidence (RWE) Capabilities & Analytics team is looking for an Associate Director , Data Strategy & Partnerships with expertise in data strategy, advanced analytics,… 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, ... documents that govern activities and updates/ revises in collaboration with legal and compliance , to drive agility and innovation as we develop and enhance ways of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryThe Director Scientific Patient Engagement Lead is responsible for developing and implementing a global headquarters strategic patient ... successful implementation of meetings with PAO leadership and executive staffEnsure compliance with existing company guidelines as they pertain to patient… 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
- Merck & Co. (Rahway, NJ)
- …DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) Team ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …Collaboration: Work closely with cross-functional teams (medical affairs, communications, regulatory , GEMs etc.) to ensure alignment and compliance ... and Reporting: Ensure all activities adhere to relevant legal, regulatory , and ethical standards. Maintain accurate documentation and generate reports on… more
- Formation Bio (New York, NY)
- …vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and ... review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, and… more
- Merck & Co. (Rahway, NJ)
- …Program Management, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk Management, Stakeholder ManagementPreferred Skills: ... Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across...of the Value Chain Management Team, guiding strategy, ensuring compliance , and enabling manufacturing excellence from development through commercialization.… 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 ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
