- Merck & Co. (Rahway, NJ)
- …development including regulatory submission and approval processes. Including development drug- device combination product or a medical device component ... of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and... Working Groups to ensure full integration of the device development activities with the clinical, regulatory ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Merck & Co. (Rahway, NJ)
- …of technical business solutions, reviewing and approving medical device /combination product documentation to support regulatory filings and audits ... Job DescriptionReporting to the Director of Medical Device and Combination Product Quality... device development and commercialization, product approval, and/or regulatory inspection experience with medical devices.Must be… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.Able to write detailed investigation summary memos ... documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and CDR rules,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory requirements. This position has experience working within the medical device and/or pharmaceutical industry across complex disease areas, and ... an ongoing basis according to applicable Daiichi Sankyo and regulatory requirements. Study Closure: Accountable for medical ...data management medical coding experience in a medical device , pharmaceutical company, or similar environment… more
- Merck & Co. (Rahway, NJ)
- …BS Required Experience and Skills: Experience in the pharmaceutical, biotechnology, chemical, medical device , or closely related industry.- Experience in one or ... (including new modalities such as ADCs) to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …systems (Ethernet) 10 plus years of experience at a medium to large scale medical device , Pharmaceutical or biotechnology process firm in an automation role is ... the BMS system throughout the component and software lifecycle Provide input during regulatory inspections of BMS and relevant projects as needed Work with the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and EMEA Regulatory requirements Experience at a medium to large scale medical device , pharmaceutical or biotechnology process firm in an automation role ... (5) year of direct engineering Pharmaceutical, Biotechnology or other regulatory industries experience preferred Knowledge, Skills, and Abilities: Strong knowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …database and data validation programming and/or related work experience in a medical device , biotech, or pharmaceutical company, or similar environment (eg, ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Merck & Co. (Rahway, NJ)
- …development and support for Clinical Supply Chain Strategy, Quality Planning, Medical Device /Combination Products and New Technologies, Global SAP Process ... key stakeholder groups including Global Clinical Supplies, Global Quality, Global Regulatory Affairs, Global Clinical Trial Operations, Device Development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant includes clinical or basic research in a Pharmaceutical company, a Medical device /Diagnostic company, Academic Research Organization (ARO) or Contract ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the global TA strategy by working closely with global marketing and medical leaders. Embody NN leadership behaviors, embracing innovation, leadership over process, ... teams, including Feld Sales, Marketing, Strategic Partnership and Engagement, Medical Affairs, Market Access and Public Affairs (MAPA), Portfolio Strategy,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …possess strong knowledge manufacturing within a regulated industry such as medical device , automotive, or defense.Must be detail-oriented with exceptional ... of user requirements and ensure they conform with company processes and regulatory guidance.Critical process parameter (CPP/CQA) - assure CPP/CQAs are defined and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …more than 3 year of experience.Engineering experience in the Pharmaceutical, Biotech or Medical Device industries.Experience in WFI and HVAC systems, clean and ... is maintained to meet GMP requirements.Support utilities areas in Regulatory / FDA inspections ensuring successful outcomes.Cross functional collaboration with… more
- Lundbeck (Little Rock, AR)
- …from an accredited college or university 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Lundbeck (Seattle, WA)
- …5+ years of Specialty Sales experience in Pharmaceutical, Biopharmaceutical, Biologics or Medical Device sales experience Ownership and accountability for the ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations… more
- Lundbeck (Flint, MI)
- …from an accredited college or university 4+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience Must ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with FDA, advertising and promotion, anti-kickback, antitrust, privacy, pharmaceutical or medical device product liability) preferred though not required Strong ... and individuals in other NNI departments, including but not limited to Medical , Regulatory , Marketing, Sales, Commercial Operations, and Ethics, Compliance &… more
- Merck & Co. (Rahway, NJ)
- …large molecule development programs.-Additional experience in drug substance manufacturing and medical device and/or combination products would be preferred.- ... the resolution of issues affecting quality and efficiency.Interpreting complex regulatory requirements for various audiences, including source area management, and… more
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