- Novo Nordisk Inc. (Plainsboro, NJ)
- …items are created, approved submitted and maintained for use. The Labeling Specialist is also responsible for maintaining product and establishment registrations ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Merck & Co. (Durham, NC)
- …team is seeking a highly motivated individual to serve as a Senior Operations Specialist within the Operations Manufacturing Support team. -In this role, you must be ... Responsibilities include, but are not limited to: Supports the end-to-end product Value Stream Map driving production improvements, inventory management, cost… more
- Merck & Co. (Durham, NC)
- …of Deviation Management, Complaints, Corrective Action/Preventive Action Management, Annual Product Review Authoring, and Quality Council.The Senior Specialist , ... with strategic direction facilitated by our global business model and regulatory compliance.--General Profile:Investigation of Product Quality Complaints and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Maintenance Specialist I (3rd shift) as part of the Facilities & Engineering team ... troubleshooting ability to drive effective and robust production, testing and release of product to patients. This person must be able to work 3rd shift/overnight… more
- Merck & Co. (Durham, NC)
- …includes facility start up, licensure, and ramp up to full production. As a Specialist , Operations you will be in a critical position to the organization with direct ... you are looking to build or expand your career in Vaccine Manufacturing. As a Specialist you will be given the opportunity to challenge and grow your talents through… more
- Legend Biotech USA, Inc. (Iowa City, IA)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Senior Cell Therapy Account Specialist as part of the Commercial team based Remote / Field based in ... Iowa and Nebraska. Role OverviewThe Cell Therapy Account Specialist is responsible for representing Legend's products and services to a defined customer base,… more
- Merck & Co. (North Wales, PA)
- …Office (PMO), and Administrative Professionals. - Position Description/Summary - The Senior Specialist , Project Manage r is a core member of Early Drug Development ... and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive cross-functional… more
- Merck & Co. (Rahway, NJ)
- …compliance with promotional, positioning and pricing policies.Interface with appropriate R&D and regulatory teams to ensure existing and new product development ... brand messaging, internal and external communications including all marketing, advertising, product pricing and related trade and industry programs. He/she will be… more
- Merck & Co. (Rahway, NJ)
- …including first-line leader for day-to-day operations activities.- Adherence to regulatory , global and site policies and procedures governing activities is ... areas/processes to identify process improvements and ensure adherence to regulatory requirements.Author, review and approve SOPs related to operational… more
- Merck & Co. (Rahway, NJ)
- …development related meetings (i .e., Clinical Trial Team s ) and product development related meetings . The incumbent must have demonstrated understanding of ... E2E product development process & connectivity between functions supporting pipeline...Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's ... biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred Experience with Quality Assurance oversight and support for all… 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
- Omnicell (Tampa, FL)
- ** Product Regulatory Specialist II (Quality Assurance Engineer II)** Reporting to the Manager of Product Regulatory and located at the Omnicell ... the Quality and Regulatory Engineer will be responsible for supporting product regulatory activities. **Responsibilities:** + Maintain and track product … more
- DuPont (Wilmington, DE)
- …(https://careers.dupont.com/us/en/whyjoinus) As part of a global Product Stewardship and Regulatory (PS&R) team, the PS&R Senior Specialist will lead ... throughout each stage of the product life cycle + Leads product regulatory compliance strategy globally with support from regional regulatory experts +… more
- Capgemini (Nashville, TN)
- …impacts on product quality, safety, and regulatory compliance. + The Product Change Control Specialist ensures that all product changes are ... reviewed, evaluated, and implemented in a controlled manner, minimizing risks to product quality and ensuring compliance with regulatory requirements. +… more
- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** The **Principal RA Specialist - US New Product Introduction** will work on-site out of ... metrics/information. **What You'll Work On** + Develop global regulatory strategies for product development and planning throughout the product lifecycle.… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Specialist II, US Product CMC Regulatory Affairs supports the ... for various tasks and responsibilities performed in the context of regulatory submissions and maintenance, change management activities, and compliance related… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** Senior Regulatory Affairs Specialist - hybrid - Covington, Georgia Urology and Critical Care (UCC) is an established and trusted ... process in the Acute Care Hospital setting. The Senior Regulatory Affairs Specialist is responsible for preparation...help support RA management. **Key responsibilities will include:** + Regulatory support through the product life cycle… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) Manager of Regulatory Affairs, the Specialist of Regulatory Affairs provides ... design and/or development in support of worldwide registrations. The Specialist of Regulatory Affairs will ensure functional...registration of products + Provides a high degree of regulatory expertise and experience to MMS-PA's new product… more
- J&J Family of Companies (Cincinnati, OH)
- …Surgery, part of Johnson & Johnson MedTech, is currently recruiting for a Senior Regulatory Affairs Specialist . This role will work a Flex/Hybrid schedule and ... health for humanity. Learn more at https://www.jnj.com/. The Senior Regulatory Affairs Specialist is responsible for ...resolution of regulatory issues and questions from regulatory agencies during the pre-market product development… more
