- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global … more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …EPA, OSHA, and the FDA. Monitors and ensures company compliance with regulatory standards.Excellent organizational and communication skills.#Li-JK2#Li-HybridThe ... Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position… more
- Merck & Co. (Rahway, NJ)
- …Management Professional) certification.Experience with Agile and Lean methodologies.Knowledge of regulatory requirements and compliance in the pharmaceutical ... Execution Excellence. We are looking for a season Program manager with a passion for driving impactful business outcomes...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of… 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 ... analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Marketing, CX and Marketing Enablement, Market Access, Legal, Compliance , Insights/Analytics, Communications, Finance, and Market Research. External relationships ... and optimizations across both live and self-service support Maintain robust compliance , quality and privacy standards in handling customer information and programs… 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
- Merck & Co. (Rahway, NJ)
- …within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans for all activities ... clinical supplies.-Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Partner with all operations work-cells to implement process improvements. Assure regulatory compliance and technical feasibility of proposed changes.Serves as ... Legend Biotech is seeking an Investigations Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Manager of CAR-T… 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)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Merck & Co. (Rahway, NJ)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our… 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 ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities:Reconcile the… 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. This position requires excellent project and people management skills, verbal/written… 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 ... Experience using generative artificial intelligence tools preferred. * Professional regulatory compliance certification preferred. * Excellent analytical skills… more
- Moss Adams LLP (New York, NY)
- **Financial Institutions Consulting Manager - Regulatory Compliance & Internal Audit** **Description** At Moss Adams, we champion authenticity. For us, that ... **Introduction to the team** The Financial Services Advisory group provides regulatory compliance , internal audit, information systems and related consulting… more
- Fiserv (Berkeley Heights, NJ)
- …functional teams. + Bachelor's degree **What would be great to have:** + Certified Regulatory Compliance Manager certification (CRCM) or Juris Doctor (JD). ... global scale, come make a difference at Fiserv. **Job Title** Lending Regulatory Compliance Director **What does a successful Lending Regulatory … more
- TD Bank (New York, NY)
- …of enthusiastic colleagues dedicated to setting new industry standards The US Compliance Regulatory Inventory Governance (RIG) Office identifies regulatory ... + Experience developing/maintaining regulatory inventories. + In-depth knowledge of regulatory compliance . + Ability to assess regulatory changes… more
