- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. We are currently seeking a Global Regulatory Affairs Labeling Operations Intern for Summer 2026. This full-time ... Summary:We are seeking a detail-oriented and tech-savvy student to join our Global Regulatory Affairs Labeling Operations team as an intern.The Global … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Automation Specialist provides end-to-end automation and quality engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & ... sterile clinical manufacturing within Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering (Pharm Ops Engineering). The role ensures reliable,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports to the Senior Director of the GxP Compliance & Technical Operations or the Director, GxP Compliance, Patient Safety, & Vendor Oversight. This job will ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...understanding and adherence Key Area #3 Performance Monitoring and Reporting Define key performance indicators (KPIs) for GxP documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical ... for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in... levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibility for clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget. The SDL will partner ... standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics,… more
- Insmed Incorporated (NJ)
- …Small Molecules, to help us expand what's possible for patients with serious diseases. Reporting to the SVP, Technical Operations , you will lead all Chemistry, ... activities for the company's small molecule pipeline. As a senior leader, you will oversee drug substance and drug...vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs, Operations , and Commercial teams to… more
- Insmed Incorporated (NJ)
- …you?About the Role:The Director, EHS (Environmental, Health, and Safety) isa senior -level role responsible for creating and implementing programs that ensure ... workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key...of a company-wide EH&S program that encompasses both lab operations and office environments. This critical leadership role will… more
- Insmed Incorporated (NJ)
- …we do. We are seeking an experienced leader to oversee cybersecurity operations , enterprise risk management, and Computer Systems Validation (CSV) program. This role ... will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, Cybersecurity… more
- Novo Nordisk Inc. (Boulder, CO)
- …Functions Lead, manage, and advise all aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved ... meeting patient and business needs Rapidly and accurately communicate issues to Senior Leadership. Resolve manufacturing and facility issues to mitigate any supply… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Relationships Reports to the Director, Media & Stakeholder Relations, and interacts with senior leaders across all areas of Novo Nordisk US Operations (USO), ... and Public Affairs, Legal, Finance and Investor Relations, Clinical, Medical and Regulatory , plus other cross functional teams as needed. Key relationships in NN/AS… more
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