- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Principal Scientist - Device Development Lead (Director Equivalent) Our company's Device Development (DD) Team designs, ... develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective...action.- The DD Team manages the development of the device constituent of our company's pipeline of combination products… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Development (DD) Team is seeking a hands-on analytical characterization and design focused engineer. This position will be ... responsible for technical interrogation of the various drug delivery device technology platforms supporting our company's pipeline to identify risks (ie when/how… more
- Merck & Co. (North Wales, PA)
- …but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director ... is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. This position will interact with… more
- Insmed Incorporated (Bridgewater, NJ)
- …(PIP).Responsible for QA representation in Design Control Process for medical device products and combination products.Lead the quality assessment for product ... familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing.Must perform statistical analysis… more
- Merck & Co. (Rahway, NJ)
- …Affairs, Regulatory, Legal etc. as well as external partners (diagnostic & device technology companies, reference laboratories, etc.) and is fundamental to the ... Product management experience with regulated Software as a Medical Device (SaMD), and/or Digital Pathology Experience commercializing and launching oncology… more
- Eisai, Inc (Nutley, NJ)
- …two or more of the following areas: infusion, diagnostic, biologic, medical device , buy and bill, rare disease, specialty pharmacy, and/or neurology. (Neurology and ... internal success is required. A combination of infusion, diagnostic, biologic, medical device , buy and bill, rare disease, or specialty pharmacy experience is… more
- Merck & Co. (Rahway, NJ)
- …the latest mobility requirements and policies.Work with various wireless carriers, device manufacturers, software vendors to understand their strategies in providing ... with developing and communicating new mobility services offerings and device standards.Represent Mobility Infrastructure Services on various IT projects and… more
- Merck & Co. (Rahway, NJ)
- …system expansion projects from either a computer system perspective or from a field device perspective as well as also leading any efforts to relocate, remove or ... to learn and contribute.Knowledge of automation items such as wiring, electrical, device selection or integrationCandidate must be able to work independently and as… more
- Aequor (Thousand Oaks, CA)
- …a Sr. Associate Supply Chain to be a part of our Global Raw Materials and Device (RMD) Supply Chain group. The Sr. Associate will work from Remote US Location or in ... and address issues with PO submission for applicable raw material & device suppliers Ensure timely availability of consolidated forecast to RMD Category Managers… more
- Aequor (TX)
- Job Description: Must Haves: Must have Medical Device experience. (Not Pharma) European MDR Experience Manufacturing background 4 Years of experience minimum (pure ... training and guidance to Site Regulatory Assessors on EU Medical Device Significant Change Notification reporting requirements Support the implementation of project… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and experience with ... years of data management and/or related work experience in a medical device or pharmaceutical company, or similar environment (eg, CRO) required4+ years combined… more
- Merck & Co. (Rahway, NJ)
- …commercialization. Our development teams ensure robust composition, primary packaging/ device , and process selection through deep fundamental understanding and ... characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team, Clinical Safety and Pharmacovigilance Medical Affairs, Companion Diagnostics/ Device Laboratories Vendors/ CROs Leadership/ Team Management Create a high ... performing team environment and a cohesive culture driven by values of integrity, respect, and culture of speak up with non complianceLead and hold others accountable to performance, talent, and development objectivesCreate an environment that fosters… more
- Catalent (MA)
- …of 3 years of sales experience in the bio, pharma, medical device industries, or other related industriesExperience in developing and negotiating complex contracts ... specificallyBachelor's degree in scientific area required. Science related MS, Ph.D. or MBA (with science BS) preferred.Why You Should Join CatalentJoin a high growth and fast paced organization with a people focused cultureGlobal exposure, defined career path… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trial sites to support trial start-up strategies Provides system and device expertise to train and support clinical trial sites Ensures ongoing collection ... and review of relevant documentation eg, related to protocol amendments, site staff and location changes and IRB/REB/regulatory approvals to assure quality of the documentation files and compliance with NN SOPs, relevant regulatory requirements and ICH and GCP… more
- Merck & Co. (Rahway, NJ)
- …of all of the details of automation including wiring, electrical, device selection and integrationExperienced problem solver/troubleshooter, skilled in root cause ... analysisAbility to prepare Standard Operating Procedures (SOP) and cGMP documents.Experience with Quality SystemsExperience in supporting compliance investigations and change management.Familiarity with US and EU GMP and Safety compliance regulationsEffective… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design, coding/dev and deployment process Reviewing and implementing browser and device support criteria across digital content Audit and evaluate existing content ... and functionality Establish and enforce coding standards, best practices, and guidelines for UX development Collaborate with backend architects to ensure smooth integration between front-end Physical Requirements 10-20% overnight travel required.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience; including hands on related pharmaceutical or medical device /pharmaceutical combination product experience and actual regulatory experience Advanced ... knowledge of pertinent FDA regulations Detail & deadline oriented; well organized Excellent verbal & written communication skills Experience leading projects in specific regulatory area preferred Good interpersonal skills; ability to interact with staff on all… more
- Lundbeck (New York, NY)
- …of Specialty Sales experience in Pharmaceutical, Biopharmaceutical, Biologics or Medical Device sales experience Ownership and accountability for the development and ... execution of a fully integrated account plans Self-starter, with a strong work ethic and outstanding communication skills Proven track record of consistent sales performance Must demonstrate the intellectual capacity to score highly on disease and product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and/or post marketing in clinical research, pharmaceutical, CRO or medical device setting required- Experience within oncology therapeutic area and/or in late ... phase projects is desirable preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion,… more
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