- 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
- Insight Global (Rahway, NJ)
- …https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements 10 years' experience in Medical Device Combination Product / Drug Delivery ... and Risk Management Engineer on the Combination Product Team, specializing in a unique drug ... development, commercialization and life-cycle management activities of medical device and combination products. They will be… more
- Merck (Rahway, NJ)
- …and the fundamentals of documentation structure/systems + Experience with medical device combination product commercialization, operations support, and ... supporting global and site-specific projects, including those related to Combination Products and Drug Delivery Systems. The...Utilize device risk management tools to build device or combination product risk… more
- Merck (Rahway, NJ)
- …responsible for translating a therapeutic agent into a functional drug product optimized for patients. The Device Development & Technology department's ... project with key tasks that include, but not limited to, the following: combination product design and process development, mechanical test method development… 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
- Stryker (Mahwah, NJ)
- …plans for the product or portfolio * Apply clinical knowledge in combination with technical knowledge to educate and articulate value * Work closely with sales ... (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) Develops specific marketing plans and activities for specific product (s) or product line(s) to establish, enhance… 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)
- …formulators and device engineers to develop robust and innovative drug product manufacturing processes. Close partnership with colleagues from Formulation ... commercial formulation development and GMP clinical supply manufacture of our Company's drug product pipeline. The FLEx Process Engineering Lead drives process… 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
- Bausch Health (Bridgewater, NJ)
- …+ 5 years quality experience, 3 years minimum in Pharmaceutical or medical device Quality Organization with handling of Annual Product Reviews (APRs), ... global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology,… more
- Pfizer (Pearl River, NY)
- …Documentum platforms **Nice-to-Have** + Experience in Quality Systems in pharmaceutical, medical device , or combination product industry + Quality experience ... directly impact patients. **What You Will Achieve** As a QA Manager, ADC (Antibody- drug conjugates) Operations, you will be a member of Pfizer's dedicated and highly… 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