- 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. (Durham, NC)
- …a comprehensive technology transfer of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse ... new HPV vaccine drug substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will be accountable for the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …hires during on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal/external SOPs/rules and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Merck & Co. (Millsboro, DE)
- …to our Company guidelinesBrings together the right stakeholders to ensure compliance and sustainability of IT/OT solutionsParticipate in regulatory audits ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Manage and oversee all assigned projects/products/processes. Assist the Director /Associate Director in assuring Novo Nordisk compliance with internal SOPs ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …hires during on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal/external SOPs/rules and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …communication (oral, written, and presentation) and interpersonal skills Knowledge of regulatory , legal, privacy and healthcare compliance requirements preferred ... focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include… more
- Catalent (Harman, WV)
- …to ensure a process of business recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related to ... Senior Director , Supply Chain Position Summary: The Senior ...sustains customer relationships through direct interaction, responsiveness and accountability.Insures compliance with all corporate and applicable regulatory … 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
- 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
