- 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)
- …, and process development including regulatory submission and approval processes. Including development drug - device combination product or a medical ... device component manufacture and final assembly of biologic/ drug product with device constituent...minimum of 10 years of combined experience in medical device and combination product development.… 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
- Sanofi Group (Bridgewater, NJ)
- …engaging with FDA, EMA, notified bodies spanning medical device , drug - device combination products, medicinal product , SaMD, and IVD with strong ... solid foundation in user-centered design principles specifically in medical device , drug -delivery, and/or drug - device combination products industry.… more
- J&J Family of Companies (Raritan, NJ)
- …+ Medical device development experience, preferably late-stage development is preferred. + Drug device combination product development experience is ... translate insights into opportunity statements and customer requirements to guide product development. + Collate feedback and insights on standard-of-care techniques… more
- Wells Fargo (New York, NY)
- We are seeking a Lead Digital Product Manager as part of Strategy, Digital & Innovation. This lead will be responsible for managing the overall strategy of the ... Device Trust Capability as part of an Authentication capability....capability for the 6 quarter roadmap. Works daily with Product Owners and stakeholders within the fraud, model governance,… 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
- Merck (Rahway, NJ)
- …pursuit of resolving scientific/technical packaging issues. + Significant experience with medical device or combination product transfer, operations support, ... and packaging processes. + Knowledgeable of design control, medical device , combination products, pharmaceutical packaging and related scientific/technical… more
- Merck (Rahway, NJ)
- …of regulatory activities with cross- product or cross-functional impact, including drug device / combination products and software-as-medical device ... Providing quality advice to stakeholders creating optimal development, commercialization, and drug /delivery device supply strategies + Building our leadership… 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)
- …Manufacturing & Controls (CMC) aspects of clinical phase through market product registration for the assigned portfolio of small molecule, biologic, biosimilar ... and/or combination products which are acquired or licensed externally as...strategies and execution of clinical study phase and initial product registration activities in an efficient, agile manner. +… 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
- Teva Pharmaceuticals (Parsippany, NJ)
- …**The opportunity** The Medicaid Claims Analyst is responsible for Medicaid Drug Rebate process which includes validating, verifying, disputing when necessary, and ... and qualifications** Education Required: + Bachelor's degree or equivalent combination of experience, training and/or direct work-related experience. Experience… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …**The opportunity** The Medicaid Claims Analyst is responsible for Medicaid Drug Rebate process which includes validating, verifying, disputing when necessary, and ... **Position Requirements:** Education Required: + Bachelor's degree or equivalent combination of experience, training and/or direct work related experience.… more