- 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
- 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
- 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
- Novo Nordisk Inc. (Virginia, WA)
- …with superior ability to lead through change. Relationships Internally, the Educator Manager (EM) reports to a Region Business Director (RBD) in the Commercial ... work is focused on those standards Ensure teams effectively identify "at risk " patient populations and utilize education and other relevant treatment guidelines to… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... supply of API, during the execution of the job duties, the senior manager should seek to actively support continuous improvement initiatives and identify wherever… more
- 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
- 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
- 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
- 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)
- …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
- 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
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Project Manager II is responsible for managing larger, more complex projects or multiple projects simultaneously. This role focuses on driving ... implementing project strategies, and ensuring alignment with business objectives. The Project Manager II serves as a key contributor to the organization, fostering… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for overseeing the health of the manufacturing processes. This starts with proper risk analysis in manufacturing design, then goes into addressing risk in ... Engineer will participate in Internal Audits as directed by the Quality Manager . In addition, the Quality Engineer will lead continuous improvement efforts following… 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
- 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. (Durham, NC)
- …process control systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus & ... Standards "Gatekeeper". Relationships Senior Project Manager - OFP. Essential Functions Support plans to maintain...within compliance with a Quality Mindset that focuses on risk management & mitigation Implement effective Change Management Support… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …System (BMS) and Environmental Monitoring System (EMS). Relationships Reports to: Manager of Automation Engineering Essential Functions Lead, plan, organize and ... throughout the component and software lifecycle Provide input during regulatory inspections of BMS and relevant projects as needed...and relevant projects as needed Work with the project manager to coordinate the activities and needs of the… more
