- Insight Global (Rahway, NJ)
- Job Description Insight Global is seeking a Combination Device Development Project Manager to join a pharmaceutical client's Device Product & Process ... DPPD Team manages the development of the device constituent of our company's pipeline of combination...reports/dashboards/risk register that summarize key progress and issues on development programs across different device project… more
- Merck (Rahway, NJ)
- …focuses on the design, development , and commercialization of novel biologic/drug/vaccine- device combination products for safe and effective delivery to their ... sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic… more
- Sanofi Group (Morristown, NJ)
- …Development , manufacturing, quality, supply chain) and drug product development . Combination product and drug delivery device systems technology is often ... on assigned projects. The role will represent the GRA Device perspective as a member of project ...lifecycle management activities for device aspects of combination product submissions. + Contribute to product development… more
- Sanofi Group (Morristown, NJ)
- …closely with key stakeholders including clinical, medical affairs, Industrial Affairs ( Device Development , manufacturing, quality, supply chain) and drug product ... team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro...part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development .… more
- Pfizer (Parsippany, NJ)
- …for device lifecycle management of on-market medical devices and combination products + Develop change management technical impact assessments, design and ... accelerated development timelines + Contribute expert level knowledge of device standards, regulations, processes and/or technology to ensure project success… more
- Merck (Rahway, NJ)
- …JANUS IT system. This position interacts closely with cross functional teams, including Device Development & Technology (DD&T), working in the system in support ... to act as Lead System Owner of the Medical Device and Combination Product (MDCP) Design Controls...guidance to our Manufacturing Division and our Research & Development Division device functions and other personnel… more
- Merck (Rahway, NJ)
- …focuses on the design, development , and commercialization of novel biologic/drug/vaccine- device combination products for safe and effective delivery to their ... of design verification testing strategies for innovative combination products? Join our company's Device Product & Process Development (DPPD) Team, which… more
- Bayer (Whippany, NJ)
- …Understand and communicate scientific principles and regulatory requirements relevant to global drug- device combination product development ; + Provide global ... etc.); + Lead and/or participate in key new product development Regulatory Affairs Teams and/or Global Project ...regulatory assessments for requirements of drug- device combination products according to existing global… more
- Grifols Shared Services North America, Inc (Freehold, NJ)
- …countries and regions. **Summary** Grifols Diagnostic Solutions is seeking a Senior Project Management Manager to help oversee our West Coast customers. This ... coordinate the available GDS and third-party staff necessary for each go live project . This position is also responsible for collaborating with resource managers of… more
- J&J Family of Companies (Raritan, NJ)
- …for:** + Design, manage and conduct microbiology lab testing for new product development and life cycle management projects of combination products, including ... media preparation, spectrophotometers, colony counters + Ability to work in a project -driven, collaborative team setting in the Medical Device industry… more
- New Jersey Institute of Technology (Newark, NJ)
- …especially microfabrication. - Experience in cleanroom operations and business development . - Well-developed project management and organizational skills ... Title: Associate Director of Operations and Business Development Department: York Center for Envir Engr and...oversee the technical aspects of MIC and business and project management aspects of both the centers. Working closely… more
- Merck (Rahway, NJ)
- …Skills: . **Manufacturing** - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination Products. ... with External Partners that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver… more
- System One (Park Ridge, NJ)
- …Senior Writer will lead and drive the technical (CMC) writing to accelerate the development of small molecules, combination drug/ device products, and other ... areas with high unmet medical needs. + Coordinating reporting needs with project teams, regulatory strategies, and product development timelines. The incumbent… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …the areas of biologic/small molecule drug substances, drug products, and drug- device combination products. + Determine regulatory and scientific/technical ... including biologic upstream and downstream processes, analytical methods, and drug/ device combination products. + Comprehensive knowledge and experience… more
- Terumo Medical Corporation (Somerset, NJ)
- …part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations ... Brand Communications Manager is responsible for managing the strategic development , planning and implementation of digital and traditional brand communications… more
- Terumo Medical Corporation (Somerset, NJ)
- …part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations ... product commercialization plans. Collaborate with training partner to support the development of sales education with updated materials and communicates on an… more
- Grifols Shared Services North America, Inc (New Brunswick, NJ)
- …+ May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed ... implements worldwide regulatory programs for marketed products and/or those for development , and has interactions with regulatory authorities to expedite approvals.… more
- Terumo Medical Corporation (Somerset, NJ)
- …of Enterprise Risk Management or related experience required, preferably in medical device ; or equivalent combination of education, training and experience. + ... part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations… more
- Terumo Medical Corporation (Somerset, NJ)
- …part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations ... Summary** The Manager, Digital Learning Experience er drives the development , engagement, and transformation of knowledge, skills and organizational capabilities… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and executing downstream commercial tactics, assessing and executing market development activities, generating and creating content to drive sales globally, ... and customer insights to maintain deep market and customer knowledge using a combination market research, internal and external data sources, and external trends and… more