- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation ... and ensure its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis ... and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position develops and proposes strategies for laboratory data ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… more
- Merck & Co. (Rahway, NJ)
- …more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to ... cross-functional experts as necessary to facilitate progress.Actively participate in regulatory audits and inspections in close collaboration with business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM, ... and related processes, policies, regulatory requirements and ICH guidance.... requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, organizational,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo… more
- Eisai, Inc (Nutley, NJ)
- …and drug development plans within the clinical development. Works with the clinical, project management, and data manager teams on strategic designs of studies; ... & Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management,… more
- Merck & Co. (Rahway, NJ)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... least three (3) years in direct management of shop floor production activities. Project Management - Proficient with Project Management and Virtual Collaboration… more
- Insight Global (New York, NY)
- Job Description Insight Global is looking for a Regulatory Project Manager for one of our top financial clients in the New York City area. The successful ... . Skills and Requirements 5+ years of experience as a project manager Background in regulatory projects Strong understanding of capital… more
- Robert Half Management Resources (New York, NY)
- Description Robert Half is seeking a Senior Technical Project Manager with strong regulatory remediation expertise. + Ideal Senior Risk & Project ... or OCC. + 8+ years experience in dealing with regulatory related findings such as MRA's and MRIA's or...regulations, compliance processes, and industry best practices. * Exceptional project management skills with a focus on delivering results… more
- RWJBarnabas Health (Somerset, NJ)
- …through establishing, tracking project milestones and coordinating submissions. Manager assists in obtaining regulatory approval for enterprise programs ... Regulatory Planning Manager (Hybrid) - Somerset,...outpatient shifts, resource consumption, payer categories, etc. + Provides project coordination support for the department, including designing spreadsheets,… more
- TD Bank (New York, NY)
- …enthusiastic colleagues dedicated to setting new industry standards. The Compliance Regulatory Change Office (CRCO) supports TD business lines in identifying, ... assessing, and implementing regulatory change. The Regulatory Implementation Team within...progress (including metrics formulated in Excel) + Collaborating with project teams/business + Escalating when the business is not… more
- Grifols Shared Services North America, Inc (Newark, NJ)
- … authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to ... approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced… more
- City National Bank (New York, NY)
- *GRC REGULATORY AFFAIRS AND GOVERNANCE MANAGER * WHAT IS THE OPPORTUNITY? Position reports to the Head of Regulatory Affairs & Governance in the GRC Office ... and will be responsible for reviewing regulatory communications concerning remediation within the GRC program and ensuring the Bank and RBC US/Combined US Operations… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As an Senior Manager , Global Regulatory Affairs, Precision Medicine, you will help develop ... and execute Precision Medicine regulatory strategy in alignment with the drug global ...in a team-oriented, matrixed environment. + Strong organizational and project management skills (familiarity with MS Office Suite, SharePoint,… more
- American Express (New York, NY)
- …impact, and together, you will help us define the future of American Express. ** Regulatory Compliance Manager ** American Express Company is seeking a skilled ... role will support the proactive identification, assessment, and implementation of regulatory changes across the organization, ensuring that all business units adhere… more
- American Express (New York, NY)
- …programs and reporting. Corporate Functions Control Management is looking for a ** Manager of Governance, Regulatory Change Management** , focused on ensuring ... multiple partners across numerous business units, functional areas, and geographies. The Manager will primarily be responsible for ensuring regulatory changes… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The ** Project Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/Clinical Research Sponsor ... regulatory requirements, and facilitating collaboration among multidisciplinary teams to meet project goals. The Project Manager II will work closely… more
