- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address...our Company marketed products . Analyzes and anticipates project risk s as they relate to clinical supply chain… more
- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business. The Program Clinical Supplies Project Manager serves as the primary program-level Global Clinical Supply point of ... development related meetings.- Working independently, the Program Clinical Supplies Project Manager designs strategic and operational plans for all clinical supply… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality...of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape Assess risk and advise on ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- 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)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and resolution) of key quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drive and shape the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with the BPQLs and ... PV/MA Quality).Participate and support lessons learned activities from audits, regulatory authority inspections, and internal process deviations delivered to program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …delivery and implementation Invests time to understand business goals, strategies, emerging risk areas, and the regulatory landscape, ensuring ability to serve ... (E&C) program by strategically identifying, assessing, and mitigating the organization's top risk areas. The role serves as an E&C Business Partner for assigned… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, ... plans across functional teamsDefines the interdependent deliverables and ensures that quality, risk , cost, time are managed within the overall approved plan to drive… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of ... manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through building positive relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across NAO, aligned to executing E&C strategy and initiatives, and responding to risk Develops communications plans to disseminate information to E&C Team, the US ... Champions a proactive approach to ethics and compliance, focusing on partnership, risk mitigation, and prevention Informs management of ethics & compliance issues in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a proactive approach to ethics and compliance, focusing on partnership, risk mitigation, prevention, and the advancement of business development areas, including ... fields is preferred A minimum of eight (8) years combined pharmaceutical, legal, regulatory , and compliance experience required OR a minimum of six (6) years'… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is ... those functions. Prepares legal documents such as contracts, correspondence (eg, to regulatory agencies), both independently and for review, approval, and use by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... within DSI and global entities, advising on legislative and regulatory compliance, lobbying activities, political contributions, public policy development, and… more
- Genmab (Plainsboro, NJ)
- …role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and others) and ... VP and Global Head of Information Security and IT Risk & Compliance, playing a strategic role in the...Security Operations TeamBusiness leaders (eg, VP Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers… more
- Genmab (Plainsboro, NJ)
- …This role will serve as Chief of Staff to the US, General Manager focusing on evolving operating models, building new capabilities, optimizing resources, and leading ... with legal and compliance teams to ensure adherence to all regulatory requirements and ethical standards.Stay updated on biotech industry trends, competitive… more
- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a single or ... in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development… more
- Citigroup (New York, NY)
- Citibank, NA seeks a Regulatory Risk Manager for its New York, NY location. Duties: Build sustainable, repeatable, and automated analytics on the Model ... EO Employer. Wage Range: $142,000.00 - $142,000.00 Job Family Group: Risk Management Job Family: Regulatory Risk **Job Family Group:** **Job Family:** **Time… more
- JPMorgan Chase (New York, NY)
- …FDIC and other banking regulators. You will report to the Regulatory Engagement Manager (REM) for the Risk , CCOR and Corporate Functions (RCCF) Team. You ... status quo and striving to be best-in-class. As a Regulatory Strategy Engagement Manager , you will lead...Regulatory Strategy and is a centralized resource supporting Risk Management and Compliance in managing regulatory … more
