- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, ... to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and… more
- Merck & Co. (North Wales, PA)
- …new and diverse problem solving.--Leadership Skills:Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work ... Job DescriptionUnder general supervision of an Executive Director/ Senior Director, the Principal Scientist /Director is responsible for developing and implementing… more
- Insmed Incorporated (Bridgewater, NJ)
- …different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.Provide scientific ... turn their passion for science and research into innovative solutions for patients. That's why we were named the...in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Director, Toxicology is a key member of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific, regulatory , and business perspectives to ensure compliance with evolving ... questions during Health Authority inspections and partner PV audits. Review and ensure compliance with PV Agreements and the regulatory labeling portion of… more
- Catalent (San Diego, CA)
- …Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance , and sound fiscal responsibility. The primary ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San...include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …by management to check principles of assuring patient safety, data integrity and regulatory compliance are sufficient Monitor and escalate GxP compliance ... 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)
- …& Director, Supply Chain Operations. This position regularly interacts with the senior leadership in Pricing & Contracting, Regulatory , Marketing, Legal, IT ... to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance and Operations works...maximize your potential with us? The Position As the Senior Director Supply Chain Operations and North America Demand… more
- Insmed Incorporated (Bridgewater, NJ)
- …Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work ... to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.ResponsibilitiesAdditional representative… more
- Merck & Co. (Rahway, NJ)
- …influences site, region and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS ... collaborative relationships with stakeholders.Demonstrated ability to successfully negotiate with regulatory agencies and senior operations leaders; escalates… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of relevant information technology systems and applications to drive systematic solutions and improvements for Corporate Compliance requirements in close ... is constantly called upon to design and implement creative solutions to complex issues. From training on new procedures,...goal is to assess impact and oversee the company's compliance with new and changed regulatory obligations… more
- Eisai, Inc (Nutley, NJ)
- …of Oncology, Neurology, and Commercial Services/Value and Market Access. Aligning training with Compliance , Legal, Regulatory , Medical, Sales and Brand will be a ... Responsible for the overall creation and delivery of customized training solutions for an evolving marketplace. This includes oversight of content development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
- Eisai, Inc (Nutley, NJ)
- …customer journeys and strategies across target audiences as well as ensure regulatory /legal and compliance requirements are met.This role requires strong ... The Associate Director, Omnichannel Marketing and Media position reports to the Senior Director, Omnichannel Marketing (HCP and Patient). The associate director will… more
- Eisai, Inc (Nutley, NJ)
- …a biopharmaceutical manufacturer capacity)Strong understanding of pharmaceutical manufacturer compliance & regulatory requirementsDemonstrated success in leading ... multidisciplinary matrix team within EisaiAdvanced understanding of pharmaceutical manufacturer compliance & regulatory requirementsAbility to operate a motor… more
- Insmed Incorporated (Bridgewater, NJ)
- …different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.Provide scientific ... Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work… more
- Merck & Co. (North Wales, PA)
- …teams in order to build partnerships and trust with Commercial Legal, Compliance , Privacy and Regulatory colleagues to effectively alleviate concerns and ... Digital & Omnichannel Innovation for US Oncology-focuses on digital health solutions and emerging customer experience and/or Omnichannel pilot capabilities. The… more
- Merck & Co. (Rahway, NJ)
- …the ability to work effectively with cross-functional teams.Familiarity with relevant regulatory guidelines and compliance requirements in the biopharmaceutical ... team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... Field Access, and Payer), Brand Marketing, Training, Market Access, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has high exposure to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …engagement risks to LOB and external contracting entities and propose effective solutions for mitigation Ensure compliance with government rules and regulations ... 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
