- Amneal Pharmaceuticals (Bridgewater, NJ)
- Description: Drug Device Combination Product Manager is a position within the Global Quality Management department.This position is a Corporate Quality ... dynamic, high paced and highly interdisciplinary environment to support Drug Device Combination Products. The...resourceful for troubleshooting and problem solving that pertain to Combination Product and Medical Devices. + Establish… more
- Merck (Rahway, NJ)
- …one of the above disciplines plus 5 years related experience + Experience with the development drug - device combination product or a medical device ... Development (DD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination ...position will be responsible for leading and implementing medical device and combination product design… more
- Sanofi Group (Bridgewater, NJ)
- …the development of connected medical devices, preferably within the pharmaceutical and drug / device combination product industries. **Languages:** English ... they meet the specific needs of the pharmaceutical and drug - device combination products. Accountable for...related to connected medical devices and incorporate them into product development strategies. Director of Connected Device … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …scientific principles and regulatory requirements relevant to global drug and drug - device combination product development, registration, and ... perform signal management process activities for assigned products, including combination products ( drug and device )...risk management, both written and verbal. + Utilizes technical combination product and device knowledge,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …oversight and contribution to product development / design control for Drug - Device Combination Products. + Collaborate with cross-functional team in ... studies, audit and inspection readiness/support, training, ICSR excellence, and Medical Device / Combination Product safety. Gilead Sciences is seeking a… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …testing network of finished goods and components for the BMS portfolio of commercial drug - device combination products. This position is accountable for the ... sites to enable efficient validation, transfer and investigation support for commercial drug - device combination products. This individual has technical… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …BU's innovation agenda and shaping the future of a broad, global portfolio of drug , device , combination products, where materials science innovation is ... make a transformative impact at BD. As Director, R&D, Product Development, you will become the architect of our...shaping the future of a broad, global portfolio of drug , device , combination products, where… more
- Pfizer (Parsippany, NJ)
- …and Control (CMC) strategist and project leader for projects within the global medical device , combination product and/or IVD portfolio. Partner with other ... efficient regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle. + Serve as a... industry + Min 3+ years of relevant pharmaceutical/medical device /IVD or combination product development… more
- Merck (Rahway, NJ)
- …background. + Experience with design of IV and SC drug products including drug - device combination products for biologics + Experience with process design ... scale, step across boundaries and implement novel innovations during drug product development to enable best science...tools, and requirements for all dosage forms (liquid, lyo, drug - device combinations) + Review and approval of… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …primary container systems such as stoppers, vials, and seals for commercial biologic drug product . This individual has technical ownership of global primary ... packaging systems for parenteral drug product throughout the commercial ...primary packaging systems. Builds a strong relationship with the combination device organization, including the individuals that… more
- Merck (Rahway, NJ)
- …candidates that will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, compatibility ... supporting regulatory filings. + Have deep fundamental knowledge around large molecule drug product development and have management responsibilities for a small… more
- Englewood Lab, Inc (Totowa, NJ)
- …cGMP, Environmental, and Regulatory audits. + Assist the Manager to create and collate product master files (dossiers), drug master files (DMF). + Generate and ... changing global regulatory requirements. + Assist with CARES Act drug reporting, Product Listing and MoCRA registrations....Three + years industry or related experience in any combination of cosmetic, medical device , food, or… more
- Englewood Lab, Inc (Totowa, NJ)
- …audits. + With the assistance of Head of R&D (or designee), create and collate product master files (dossiers), drug master files (DMF). + Generate and Review of ... + Two+ years industry or related experience in any combination of cosmetic, medical device , food, or...or manufacturing experience - a plus. + Experience of drug , cosmetic, medical device regulatory process is… more
- Bausch Health (Bridgewater, NJ)
- …7-10 years of business experience with at least 5 years in medical device and/or pharmaceutical sales/marketing functions; or equivalent combination of education ... collaboration with cross functional groups to drive downstream marketing execution, product innovation with research and development, and flow-through processes with… more
- Terumo Medical Corporation (Somerset, NJ)
- …and evaluating impact of standard/regulation updates to existing product families and QMS processes. **Job Details/Responsibilities** + Support ... service providers to execute the recall. + Support cross-functional projects (New Product Development, Sustaining, Acquisition, etc ) as a compliance SME + Act… more
- Organon & Co. (Jersey City, NJ)
- …in Regulatory CMC Biologics and/or authoring of regulatory documentation. + Device and/or combination product regulatory experience. **Professional ... but are not limited to: **Responsibilities** + Provide input to global product and project regulatory strategies by performing assessments of CMC changes,… more
- Southern Glazer's Wine and Spirits (Syosset, NY)
- …of our Top Shelf Benefits, including comprehensive medical and prescription drug coverage, dental and vision plans, tax-saving Flexible Spending Accounts, disability ... sales territories, quotas, and goals + Conduct sales meetings, product presentations, train, develop, and motivate the team to...degree plus five years of experience; or an equivalent combination of education and experience + Three years of… more
- Merck (Rahway, NJ)
- …students interested in the Regulatory field, covering small molecule drugs, biologics, drug - and biologic- device combination products, and vaccines. ... principles and strategies. This includes learning about manufacturing and testing of drug substance/ drug product /raw materials, compliance with regulatory… more
- RWJBarnabas Health (Newark, NJ)
- …as procedure booking sheets, schedules two weeks out and daily, and historical product usage to proactively prepare and forecast all procedure supply needs + ... Responsible for identifying and reporting safety concerns, medical errors, device malfunction, and facility damage walls, ceiling tiles, etc...+ Risk of injury from equipment used in moving product + Ability to lift and push up to… more
- Southern Glazer's Wine and Spirits (Syosset, NY)
- …of our Top Shelf Benefits, including comprehensive medical and prescription drug coverage, dental and vision plans, tax-saving Flexible Spending Accounts, disability ... remain apprised of market trends and development within specific product categories, geographic regions, and accounts + Support POS...Bachelor's degree in a related field; or an equivalent combination of education and experience + Five years of… more