- 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
- Sanofi Group (Morristown, NJ)
- …a project or functional context + Poven experience in drug/ device combination product regulatory approvals + Demonstrate strategic thinking, initiative, ... key stakeholders including clinical, medical affairs, R&D, Manufacturing & Supply ( device development , manufacturing, quality, supply chain) and Global Business… more
- Merck (Rahway, NJ)
- …Device Analytical Lead will partner closely with cross-functional teams, including device development and technology, quality assurance, and analytical teams ... as a Device Analytical Lead supporting medical device and combination product (MDCP) programs at...ICH and relevant HA guidelines + Experience with medical device development with understanding of Design Controls… 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
- 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 (Newark, 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
- 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
- Grifols Shared Services North America, Inc (Newark, 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
- Guidehouse (New York, NY)
- …any combination of the following: + Therapeutic area strategy development + Product opportunity assessments + Commercial strategy + Business development ... Health Care Practice. Our clients include - pharmaceutical, biotechnology, medical device , drug delivery and diagnostic. Examples of Guidehouse Life Sciences diverse… 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
- Eaton Corporation (Mountainside, NJ)
- …coordinate, and supervise on-site testing and commissioning activities as required by project scope. + Provide field engineering support to the electricians in the ... functional test plans, equipment lists, final documentation uploads, complete project binder, equipment energization lists, equipment energization notifications, and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Federal Markets including VA, Department of Defense and 340B Program preferred. + Device /Drug combination strongly preferred + Minimum 5 years of people ... (edaravone) oral suspension in 2022. The company handles research, clinical development , sales, marketing, medical affairs, supply chain,and business development … more
- Amazon (New York, NY)
- …as the ability to handle a mix of disparate tasks which may include project and software development work. This role will provide career growth opportunities ... to help secure our foundational platforms such as OS kernels, virtualization, device emulation, firmware and hardware. You will be responsible for conducting… more
- RWJBarnabas Health (Newark, NJ)
- … of clinical practice guidelines, usage tracking, MCS database, new project / device implementation and participates in program related quality ... health of local residents to creating educational and career opportunities, this combination greatly benefits the state. We understand the growing and evolving needs… more